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Anesth Analg 2002;94:100-105
© 2002 International Anesthesia Research Society

ANESTHETIC PHARMACOLOGY

The Clinical Efficacy and Pharmacokinetics of Intraperitoneal Ropivacaine for Laparoscopic Cholecystectomy

Thierry Labaille, MD*, Jean Xavier Mazoit, MD PhD{dagger}, Xavier Paqueron, MD*, Dominique Franco, MD{ddagger}, and Dan Benhamou, MD*{dagger}

Departments of *Anesthesia and Intensive Care and {ddagger}Surgery, Hôpital Antoine Béclère, Clamart, France; and {dagger}Laboratory of Experimental Anesthesia, Faculté de Médecine Paris-Sud, Bicêtre, France

Address correspondence to Dan Benhamou, MD, Department of Anesthesia and Intensive Care, Hôpital Antoine Béclère, BP 405, 92141 Clamart, France. Address e-mail to dan.benhamou{at}bct.ap-hop-paris.fr Reprints will not be available from the authors.


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 References
 
Postoperative pain after laparoscopic surgery is less than after laparotomy, and patients may benefit from an intraperitoneal injection of local anesthetic. Thirty-seven ASA physical status I or II patients received in double-blinded fashion 20 mL of 0.9% saline solution (placebo), ropivacaine 0.25% (Rop 0.25%), or ropivacaine 0.75% (Rop 0.75%) immediately after trocar placement and at the end of surgery. We measured pain and morphine consumption until 20 h after surgery. Plasma ropivacaine concentrations were measured. The three groups were comparable for shoulder pain, parietal pain, and incidence of side effects. Visceral pain at rest, during cough, and on movement and total consumption of morphine were significantly smaller in Groups Rop 0.25% and Rop 0.75% when compared with Placebo. Although no adverse effect occurred in any patient, the largest dose led to large plasma concentrations of ropivacaine (2.93 ± 2.46 µg/mL and 3.76 ± 3.01 µg/mL after the first and second injection, respectively). We conclude that intraperitoneal administration of ropivacaine before and after surgery significantly decreases postoperative pain. Because the smaller dosage (2 x 50 mg) provided similar analgesia and was associated with significantly smaller plasma concentrations than the larger dosage (2 x 150 mg), this smaller dosage seems more appropriate.

IMPLICATIONS: Intraperitoneal ropivacaine 100 mg injected during laparoscopic cholecystectomy significantly decreased postoperative pain when compared with injection of intraperitoneal placebo. At this dose, plasma concentrations remained in the nontoxic range,


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 References
 
Laparoscopic cholecystectomy is the preferred surgical technique for uncomplicated cholecystectomy, because of an improved postoperative course. The severity of postoperative pain, as well as morphine consumption, is significantly less than after an open technique (1,2), and return to normal daily activities is also more rapid with laparoscopy (3). Postoperative pain, however, does not completely disappear after laparoscopic cholecystectomy, and several studies have shown that visceral pain is the major component (4,5). Because intraperitoneal injection during gynecologic surgery has proved to be effective and safe (6,7), it was thus logical to suggest that this technique may also provide an effective block of postoperative visceral pain after laparoscopic cholecystectomy. Unfortunately, studies in which local anesthetics have been used in this setting have provided conflicting results. Most of these initial studies have used small doses of bupivacaine or of lidocaine (8,9). By contrast, two studies that have used larger doses and concentrations have demonstrated that intraperitoneal bupivacaine can be effective (10,11). Ropivacaine, an amide local anesthetic that has similar efficacy to bupivacaine at a large dose (12), also leads to reduced systemic and cardiac toxicity (13,14). Several studies have evaluated doses of ropivacaine as large as 300–375 mg for inguinal hernia infiltration (15,16) or for intraperitoneal injection (17) and have not observed any clinical evidence of toxicity. The aim of this clinical study was to investigate whether intraperitoneal ropivacaine can provide effective pain relief after laparoscopic cholecystectomy and to record the analgesic and pharmacokinetic profiles after the administration of a moderate or large dose.


   Methods
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 Abstract
 Introduction
 Methods
Results
 Discussion
 References
 
The study was approved by our ethics committee, and all patients gave written, informed consent. A power analysis with a pain score as the primary criterion (power = 0.90, {alpha} = 0.05 unilateral, with the Bonferroni correction) on the basis of our previous studies (7,18) revealed that 12–14 patients were mandatory in each group. Therefore, 42 patients with ASA physical status I–II scheduled to undergo laparoscopic cholecystectomy were included in this prospective, randomized, placebo-controlled, and double-blinded study. Patients allergic to local anesthetics and those with a history of cardiac disease were excluded. None of the patients had acute cholecystitis. After a standardized general anesthetic, each patient received two intraperitoneal injections: the first immediately after pneumoperitoneum and the second at the end of the surgery, consisting of 20 mL of 0.9% saline solution (Placebo group), 0.25% ropivacaine (total dose, 100 mg) (Group Rop 0.25%), or 0.75% ropivacaine (total dose, 300 mg) (Group Rop 0.75%).

All patients received 100 mg of hydroxyzine orally 1 h before being transferred to the operating room. Anesthesia was induced with 4–5 mg/kg thiopental, 0.3 µg/kg IV sufentanil, and 0.6 mg/kg rocuronium. After tracheal intubation, general anesthesia was maintained with 1%–1.2% isoflurane (end-tidal concentration) and 50% nitrous oxide with oxygen. Additional doses of sufentanil (0.1–0.2 µg/kg) and rocuronium (0.2 mg/kg) were administered to maintain analgesia and surgical relaxation. Ventilation was adjusted to maintain end-tidal carbon dioxide between 34 and 40 mm Hg. During laparoscopy, intraabdominal pressure was limited to 15 mm Hg. At the end of surgery, droperidol 1 mg was administered to prevent or minimize postoperative nausea.

Local anesthetic or placebo solutions were given as follows: immediately after the creation of a pneumoperitoneum, the surgeon sprayed 10 mL of solution into the hepato-diaphragmatic space, 5 mL in the area of the gallbladder, and 5 mL into the space between liver and kidney. At the end of the operation, before the trocars were withdrawn, the surgeon sprayed an additional 20 mL of the solution onto the same areas. The surgeon was not informed of the contents of the solution. Surgical wounds were not infiltrated with local anesthetic solution.

Parietal pain (defined as superficial pain located on the abdominal wall; pain that one can "touch") and visceral pain (defined as deep, dull, more difficult to localize, inside the abdomen) were assessed with a 10-cm visual analog scale at rest (supine, 10°–15° head up), on coughing, and during mobilization (rising from the supine to the sitting position). The incidence of shoulder pain was also recorded. Pain scores, morphine consumption, nausea, and vomiting were recorded immediately at the arrival in the postanesthesia care unit (PACU), at 30 min, and at 1, 2, 4, 8, 12, and 20 h after the surgery. In the PACU patients received IV morphine to obtain a visual analog scale <=3 cm. Patient-controlled analgesia morphine was then used (bolus, 1 mg; lockout interval, 7 min; maximum dose, 20 mg/4 h). If patients experienced nausea or vomiting, metoclopramide (0.5 mg/kg IV) was given. Patients were discharged from PACU according to our local score, derived from the Aldrete score (19). The total consumption of morphine and time to first request of morphine were also recorded. Patients in whom laparotomy was required during surgery and those with inadequate analgesia necessitating rescue analgesics were excluded from the study.

Nineteen patients (6 in the 0.25% group and 13 in the 0.75% group) had ropivacaine plasma concentration measurements. Two times more patients were studied in the Rop 0.75% group to evaluate more precisely the risk of toxicity. Blood (5 mL) was sampled in heparinized tubes (Vacutainer®; Becton Dickinson, Franklin Lakes, NJ) 0, 1, 5, 10, 15, 20, and 40 min after the first and 0, 1, 5, 10, 15, 20, and 40 min after the second injection. After centrifugation, plasma was kept frozen at -20°C until analysis. Ropivacaine was measured with gas chromatography (20). Briefly, 100 µL of internal standard solution (mepivacaine 10 µg/mL), 100 µL of NaOH 2 N, and 200 µL of pentane were added to 0.5 mL of plasma. After rapid vortex agitation for 45 s and centrifugation at 3500g, 2 µL of the supernatant was injected on column. The chromatograph (Varian model 3400; Varian, Les Ullis, France), equipped with a nitrogen-phosphorus detector, was fitted with a megabore J&W DB-1701 column (30 m x 0.53 mm, film thickness 1 µm) (Varian Chromatography Systems, Walnut Creek, CA). Helium was used as carrier gas at 30 mL/min, and air and hydrogen were set at 150 and 4.5 mL/min, respectively. The temperatures were as follows: injector 250°C, detector 290°C, and oven 230°C. The standard curve was linear in the range 0.01–8 µg/mL. The limit of detection at four times the basal noise was <0.01 µg/mL for the three drugs. The intra- and interday coefficients of variation were 6% and 8%, respectively, at 200 µg/mL.

Basal demographic values (age, weight, and height), duration of anesthesia, and time spent in PACU before discharge were compared between groups by using Student’s t-tests with the Bonferroni correction. Parietal and visceral pain at rest, during cough, and with movement, as well as morphine consumption during the 20 h after surgery, were compared within and between groups by using two-way analysis of variance (one-way factorial, one-way repeated), followed by a Newman-Keuls test as appropriate. The time to first postoperative morphine administration and the total morphine consumption during the 20 h after surgery were also compared between groups by using the Newman-Keuls test. The occurrence of side effects during the postoperative period was compared by using a {chi}2 test. The maximum peak concentration observed after each injection (Cmax1 and Cmax2) and the time to peak (Tmax1 and Tmax2) were compared between the two ropivacaine groups by using the Mann-Whitney U-test. Tmax1 and Tmax2 were compared within each group by using Wilcoxon’s rank test. Data are reported as the mean and SD for demographic data, pain scores, and morphine consumption and as the median value and interquartile range for ropivacaine concentration data. P < 0.05 was considered as the minimum level of significance.


   Results
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 Abstract
 Introduction
 Methods
 Results
Discussion
 References
 
Five patients were excluded from the study: two patients in the Placebo group (because postoperative pain required additional analgesics (nonsteroidal antiinflammatory drugs) and three patients in Group Rop 0.75% (two of whom had conversion to open surgery and one because of protocol violation).

Demographic data and duration of surgery were similar in the three groups (Table 1). Intraoperative sufentanil consumption was similar in the three groups (39.6 ± 8.9 µg, 41.4 ± 8.4 µg, and 40.0 ± 10.7 µg for Group Placebo, Group Rop 0.25%, and Group Rop 0.75%, respectively). A trend toward a decreased incidence of shoulder pain at rest was seen in the ropivacaine groups, but this did not reach statistical significance (60%, 36%, and 27% for Group Placebo, Group Rop 0.25%, and Group Rop 0.75%, respectively). Parietal pain at rest and during mobilization were similar for the three groups (Figs. 1 and 2). Whereas visceral pain scores were significantly greater in the Placebo group at rest, during cough, and during mobilization (Figs. 1 and 2), there were no differences between the two ropivacaine groups. A trend toward a longer time to first request of morphine in the PACU was seen for the two ropivacaine groups, but this did not reach statistical significance (40 ± 65 min, 70 ± 85 min, and 100 ± 140 min for Group Placebo, Group Rop 0.25%, and Group Rop 0.75%, respectively). Morphine consumption in the postoperative period was significantly less in the two ropivacaine groups compared with the Placebo group (42 ± 28 mg, 19 ± 13 mg, and 23 ± 17 mg for the Placebo, Rop 0.25%, and Rop 0.75% groups, respectively; P < 0.05), and the total consumption of morphine was twice as much in the Placebo group when compared with either local anesthetic group (Fig. 3). There was no difference in morphine consumption between ropivacaine groups at any time. The incidences of nausea (10%, 21%, and 9%) and of vomiting (0%, 7%, and 0%) for the Placebo, Rop 0.25%, and Rop 0.75% groups, respectively, were not significantly different.


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  		Table 1. Patient Characteristics and Surgical Data (mean ± sd)
 


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  		Figure 1. Postoperative visual analog pain scores at rest (top), during cough (middle), and with movement (bottom) in the three groups. Analysis of variance failed to demonstrate any difference among the three groups for parietal pain (left panels), whereas the two ropivacaine groups showed significantly lower scores when compared with the Placebo group for visceral pain (right panels). VAS = visual analog scale; • = placebo; {square} = 100 mg ropivacaine; = 300 mg ropivacaine.

 


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  		Figure 3. Ropivacaine concentration (mean ± SD) in the 0.25% group (•) and in the 0.75% group ({circ}).

 


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  		Figure 2. Morphine consumption during the first 20 h after laparoscopic cholecystectomy was significantly larger in the Placebo group when compared with the two ropivacaine groups. • = Placebo; {square} = 100 mg ropivacaine; = 300 mg ropivacaine.

 
Ropivacaine concentrations observed in the 0.25% and 0.75% groups are displayed in Figure 3. Peak concentrations were significantly larger in the Rop 0.75% group than in the Rop 0.25% group (Cmax1 = 2.93 [2.46–3.25] µg/mL versus 0.66 [0.53–1.51] µg/mL and Cmax2 = 3.76 [3.01–4.32] µg/mL versus 2.34 [1.71–2.56] µg/mL, respectively). It should be noted that 6 of the 13 patients in the Rop 0.75% group had Cmax2 larger than 4 µg/mL. Tmax1 was similar in the two groups (35 [20–40] min versus 30 [20–40] min in the Rop 0.25% and Rop 0.75% groups, respectively). Tmax2 was significantly shorter than Tmax1 in the 0.25% group than in the 0.75% group (15 [10–20] min versus 30 [10–40] min in the Rop 0.25% and Rop 0.75% groups, respectively; P = 0.043).


   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
References
 
This study demonstrates the analgesic efficacy of intraperitoneal ropivacaine and is similar to recent studies (10,11) showing that intraperitoneal infiltration with large doses of local anesthetics produces reliable analgesia. However, morphine requirements recorded in our ropivacaine groups were far from negligible (~20 mg/24 hours). This suggests that, although intraperitoneal injection has some effect on postoperative pain, it remains a weak analgesic technique (5). We also believe that these large doses of morphine might be related to the long duration of surgery and the fact that multimodal analgesia was not used. In the study by Bisgaard et al. (21) and in most other recent studies evaluating laparoscopic cholecystectomy, the mean duration of surgery was 60 minutes, whereas it was 120 or 130 minutes in this study. This difference is probably related to a different training level of our surgeons (22). Moreover, in the study by Bisgaard et al. (21), patients also received nonsteroidal antiinflammatory drugs and paracetamol on a regular basis.

Several studies have described pain according to the presumed mechanism: visceral or scapular pain, which can theoretically be blocked by intraperitoneal infiltration; and parietal pain, which can be blocked by portside infiltration. Bisgaard et al. (21) and Ure et al. (23) have suggested that parietal pain is the predominant cause of pain. By contrast, our data as well as others’ (4,5) indicate that visceral pain is the main cause of pain. Because visceral pain is predominant, intraperitoneal infiltration was efficient in our study. Pain assessments were repeatedly performed during the first 24–48 hours after surgery in those studies showing predominantly visceral pain (4), whereas they were performed more loosely and for a longer period in others (2). Bisgaard et al. (21) recommended parietal infiltration rather than intraperitoneal injection. Indeed, in their study, although ropivacaine 210 mg was infiltrated into the wound and portsides, parietal pain was the predominant cause of pain. Because the total dose of ropivacaine had to be limited, only 76 mg of ropivacaine was infiltrated intraperitoneally. However, they did not observe any difference with their control group. We postulate that the technique used by the surgeon may be partly responsible for the differences between the study of Bisgaard et al. and ours. We believe that, contrary to their recommendations, intraperitoneal infiltration with 100 mg should be favored, and portside injection with small doses should be a secondary aim. In addition, the surgeon needs to carefully spray the surgical site.

This study is the first one to assess two doses of ropivacaine in this clinical setting. The studies by Mraovic et al. (10) and by Pasqualucci et al. (11) have both described significant analgesic effects with a large dose of bupivacaine (i.e., 150 mg), whereas most previous studies in which smaller doses were used were unable to demonstrate any efficacy (4,9,21). When using ropivacaine, increasing the dose also seems important. Mulroy et al. (24) assessed the analgesic efficacy of doses ranging from 37.5 to 150 mg infiltrated into the wound at the time of inguinal hernia surgery (24). Only large doses produced significant analgesia. This study, as well as others that have used even larger doses after inguinal hernia, has suggested a ceiling effect at 100 mg of ropivacaine. Indeed, 100 mg of ropivacaine (24) or 300–375 mg (16) does not produce analgesic efficacy superior to 75 mg (24) or 100 mg, respectively (23). In our study, very similar results were obtained. We found that 300 mg of intraperitoneal ropivacaine did not perform better than 100 mg, with both producing better efficacy than placebo.

The large dose (300 mg) not only produced similar analgesia (when compared with 100 mg), but also led to large plasma concentrations. Cmax1 and Cmax2 were considerably larger in patients receiving 150 mg twice. Two of them had maximum concentrations >4 µg/mL after the first administration and six after the second administration. This concentration may be considered as the limit of potential toxicity (14), suggesting that a significant risk of toxicity was present. Tmax may be longer than observed in some groups, particularly after the first injection in the 0.25% group (see Fig. 3). This is caused by the inevitable limitation in sampling time. However, Tmax2 was significantly shorter in the 0.25% group as compared with the 0.75% group. Apart from a rapid absorption process caused by vascular injury in some patients at the end of surgery, a rate-limiting process in absorption might have led to slowing absorption. However, this potential limitation in the speed of absorption is not expected to protect against concentrations larger than 4 µg/mL. We did not observe clinical toxicity, but patients were injected while they were under general anesthesia and could not describe minor toxic symptoms. Only venous samples were obtained but, because of the long time to peak concentration, the arterio-venous difference would probably be relatively small (14). These plasma concentrations were obtained within 30 minutes of each intraperitoneal injection; this probably reduced the risk of systemic toxicity. Plasma concentrations observed in this study were larger than those obtained for similar doses but injected in different sites, such as the epidural space (12), or infiltrated into an inguinal hernia wound (15,16,24). The large peak concentrations of ropivacaine observed during laparoscopic cholecystectomy may be viewed as surprising regarding its well known vasoconstrictive action (25). Moreover, increased intraperitoneal pressure should have collapsed peritoneal vessels. Injection immediately after insufflation to produce preemptive analgesia (10,11) seems necessary to ensure adequate efficacy. However, surgical dissection after peritoneal infiltration may have facilitated vascular absorption.

We cannot exclude a systemic analgesic action from intraperitoneally injected ropivacaine. Indeed, IV lidocaine can be effective in visceral pain (26), and its effectiveness seems to be dose related: small doses are almost ineffective, and large doses produce almost total inhibition in some experimental models (27). Thus, further investigation is required to test whether intraperitoneal local anesthetics provide greater efficacy than after systemic injection.

In conclusion, this study has demonstrated that fractionated injection of 100 mg of intraperitoneal ropivacaine produces postoperative analgesia after laparoscopic cholecystectomy better than what was obtained with intraperitoneal placebo. Increasing the dose to 300 mg did not improve clinical effectiveness but led to excessively large plasma concentrations. One hundred milligrams of intraperitoneal ropivacaine can certainly be recommended as a routine technique to improve postoperative analgesia after laparoscopic cholecystectomy.


   Acknowledgments
 
Supported by grants from AstraZeneca France and Association MAPAR (Mises Au Point en Anesthésie et Réanimation), Paris, France.


   References
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 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 

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Accepted for publication September 14, 2001.




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Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press