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Anesth Analg 2000;91:374-378
© 2000 International Anesthesia Research Society


OBSTETRIC ANESTHESIA

Comparison of Epidural Fentanyl Versus Epidural Sufentanil for Analgesia in Ambulatory Patients in Early Labor

Neil Roy Connelly, MD, Robert K. Parker, DO, Veda Vallurupalli, MD, Shailesh Bhopatkar, MD, and Steven Dunn, MD

Department of Anesthesiology, Baystate Medical Center, Springfield, Massachusetts

Address correspondence and reprint requests to Neil Roy Connelly, MD, Department of Anesthesiology, Baystate Medical Center, 759 Chestnut Street, Springfield, MA 01199. Address e-mail to Neil.Roy.Connelly{at}bhs.org


    Abstract
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Epidural sufentanil, after a lidocaine and epinephrine test dose, provides adequate analgesia and allows for ambulation during early labor. Epidural fentanyl has not been evaluated in this setting. The current study was designed to determine whether there is an analgesic difference between epidural fentanyl and epidural sufentanil in laboring patients. Forty-six laboring nulliparous women, at <5-cm cervical dilation, who requested epidural analgesia were enrolled. After a 3-mL test dose of lidocaine with epinephrine, patients were randomized to receive either sufentanil 20 µg or fentanyl 100 µg. After administration of the analgesic, pain scores and side effects were recorded for each patient at 5, 10, 15, 20, and 30 min and every 30 min thereafter, by an observer blinded to the technique used. There were no demographic differences between the two groups. Pain relief was rapid for all patients. The mean durations of analgesia were similar between the sufentanil group (138 ± 50 min) and the fentanyl group (124 ± 42 min). Side effects were similar between the two groups. In early laboring patients, epidural fentanyl 100 µg, after a lidocaine and epinephrine test dose, provides analgesia comparable to that of sufentanil 20 µg.

Implications: In early laboring patients, epidural fentanyl 100 µg, after a lidocaine and epinephrine test dose, provides analgesia comparable to that of sufentanil 20 µg.


    Introduction
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
We previously showed that epidural sufentanil, after a lidocaine and epinephrine test dose, provides approximately 2 h of analgesia, while allowing patients to ambulate (14). The opioid most commonly used at our institution for ambulatory epidural administration during early labor is fentanyl. Fentanyl is chosen because of its ease of use (the ampule is the dose), the ability to avoid requiring a witness to waste unused opioids, and the saving of the cost of wasted medication. It is not known whether there are differences with respect to the duration of analgesia, pruritus, nausea, or sedation between fentanyl and sufentanil. We thus undertook this study to determine whether epidural fentanyl would have a profile comparable to that of epidural sufentanil, after a lidocaine and epinephrine test dose, in nulliparous patients during the early first stage of labor.


    Methods
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Before this study was initiated, institutional review board approval was obtained. Written, informed consent was obtained from 46 nulliparous ASA physical status I or II obstetric patients, at >36 wk of gestation, who had requested labor analgesia. Patients were excluded if cervical dilation was >5 cm, they had received IV opioid agonists or agonists/antagonists, they had preeclampsia, or they had a contraindication to either sufentanil or fentanyl. A normal fetal heart rate pattern (absence of decelerations) was required for inclusion in the study.

Before the procedure was begun, the patients’ vital signs (blood pressure, heart rate, and respiratory rate) were documented, and the patients were asked to relate any symptoms of pruritus, nausea, or vomiting. Each patient also completed a baseline assessment using a 100-mm visual analog scale (VAS) for pain, with 0 representing no pain and 100 representing the worst possible pain. Each patient received 1000 mL of lactated Ringers solution IV. All procedures were performed with patients in the sitting position. A lumbar epidural catheter was inserted approximately 5 cm into the epidural space by using a Tuohy-Schiff needle (B-Braun Medical, Bethlehem, PA). The patients then received a test dose of 3 mL of 1.5% lidocaine with 1:200,000 epinephrine. If the test dose was negative for intravascular injection (heart rate within 15 bpm of baseline values in 2 min of monitoring) and intrathecal injection (no signs of spinal block after 3 min of monitoring), the patient was given one of two injections in a double-blinded fashion, as follows: Group S, sufentanil 20 µg with normal saline to a total volume of 10 mL; Group F, fentanyl 100 µg with normal saline to a total volume of 10 mL.

Patients were placed in the recumbent position, with left uterine displacement. VAS scores and the severity of side effects were recorded 5, 10, 15, 20, and 30 min after the administration of the study analgesics and every 30 min thereafter. Observations were performed by an individual blinded to the analgesic technique. At the time of each assessment, vital signs, modified Bromage motor scale scores (5), and pruritus, nausea, vomiting, and sedation were evaluated. Motor block was defined as none, partial (just able to move the knees), almost complete (able to move the feet only), or complete (unable to move the lower extremities). Pruritus was rated as none, minimal (present with minimal symptoms), moderate (bothersome but not requiring therapy), or severe (requiring therapy). Sedation was categorized as none (awake), mild (drowsy), moderate (sleepy), or severe (unarousable). The fetal heart rate pattern was evaluated at each interval, and any changes were documented. After the first 30 min, patients were allowed to ambulate with assistance, provided there was no detectable motor block and the fetal heart rate pattern was reassuring. The time at which each patient requested additional analgesia was recorded, vital signs were documented, pain and side effect assessments were performed, and the study period was concluded. The epidural anesthetics were subsequently managed by the anesthesia team, as appropriate, for the remainder of labor. The length of labor, incidence of cesarean delivery, incidence of postdural puncture headache (PDPH), and neonatal Apgar scores were recorded.

A plan for treating inadequate analgesia was standardized. If a patient did not experience adequate analgesia 20 min after the initial study dose, 15 mL of 0.125% bupivacaine was administered via the epidural catheter. If this did not provide relief after an additional 20 min, 10 mL of 2% lidocaine was administered. If this did not result in an adequate level of analgesia, then the epidural catheter was replaced.

Before this study was initiated, a power analysis was performed, assuming a duration of sufentanil analgesia of 160 ± 30 min, a duration of fentanyl analgesia of 190 ± 45 min, 90% power, and {alpha} of 0.05. This yielded a required sample size of 23 patients per group.

Demographic data were analyzed by using analysis of variance. Pain scores were analyzed by using the Mann-Whitney U-test. The presence or absence of side effects was analyzed by using contingency testing. Data were expressed as mean ± SD. Significance was determined at the P < 0.05 level.


    Results
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Forty-six patients were enrolled in the study. There were no differences in demographic variables, cervical dilation at the time of enrollment, rupture of membranes, or oxytocin use between the two study groups (Table 1). Baseline VAS pain scores and the incidences of nausea and pruritus were similar in the two groups. All patients except one (in Group S) achieved adequate initial analgesia with the study medication; the patient in Group S did not receive analgesia after the administration of local anesthetic, but analgesia was achieved after replacement of the epidural catheter. The data for this patient were excluded from the analyses. The median VAS scores in both groups were decreased 56% by the 5-min evaluation (P = not significant [NS]). At 10 min, Group S had a 70% decrease in VAS scores and Group F had an 81% decrease (P = NS). There was no significant difference in pain scores between the groups at any of the time points (Figure 1). The duration of analgesia was not significantly different between Group S (138 ± 50 min) and Group F (124 ± 42 min) (Figure 2).


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Table 1. Demographic and Outcome Data for the Fentanyl and Sufentanil Groups
 


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Figure 1. Visual analog scale (VAS) pain scores for the two groups at times up to 2.5 h. The boxes represent the 25th–75th percentiles, and the solid lines represent the medians. The extended bars represent the 10th–90th percentiles. The circles represent values outside this range. Pain scores were not obtained after the administration of additional analgesia.

 


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Figure 2. Duration of analgesia in the two groups. The boxes represent the 25th–75th percentiles, and the solid lines represent the medians. The extended bars represent the 10th–90th percentiles. The circles represent values outside this range.

 
Before the administration of the study analgesic, 13 patients had experienced nausea (5 in Group S and 8 in Group F) and 5 patients had vomited (2 in Group S and 3 in Group F). During the entire study period, 8 patients experienced nausea (4 in Group S and 4 in Group F) and 5 patients vomited (3 in Group S and 2 in Group F). Eleven patients experienced mild sedation at least once during the study period (6 in Group S and 5 in Group F, P = NS). No patient experienced moderate or severe sedation. At no time did any patient experience severe pruritus. There was no significant difference between the groups with respect to having at least one period of mild pruritus (9 of 22 in Group S and 14 of 23 in Group F, P = NS). At 30, 60, 90, 120, 150, and 180 min, the numbers of patients with moderate pruritus were 0, 2, 3, 4, 0, and 0, respectively. None of the patients delivered without the need for redosing. Cervical dilation was significantly greater at the time of redosing in Group S (P < 0.003) (Table 1). However, there was no significant difference between the groups with respect to the time from the initial dose to the time of achieving full cervical dilation (Table 1). The incidences of cesarean deliveries were not significantly different between the groups (5 in Group S and 6 in Group F). None of the patients required a cesarean delivery before the need for a redose. The time from redose to cesarean delivery was 8 ± 3 h (minimum 4 h, maximum 12 h). No patient had an inadvertent dural puncture and no patient in either group had symptoms of a PDPH.

During the study period, no patient experienced any detectable motor block. Eighteen patients (40%) ambulated at least once during their labor (9 in Group S and 9 in Group F). Apgar scores at birth were comparable for the neonates in the two groups.


    Discussion
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Much of the recent literature on labor analgesia has focused on the intrathecal administration of opioids, with and without local anesthetics (6,7). Epidural sufentanil at a dose of 40 µg, after 3 mL of lidocaine with an epinephrine test dose, provides analgesia equivalent (in quality and duration) to that provided by 10 µg of intrathecal sufentanil (1). An epidural dose of 20 µg of sufentanil, after 3 mL of lidocaine with an epinephrine test dose, was also shown to provide analgesia for early labor, in a group of nulliparous or multiparous patients, equivalent to that provided by 40 µg of epidural sufentanil (3). In treating patients with ambulatory epidural injections, we prefer the epidural opioid technique, rather than the combined spinal epidural (CSE) technique, because the former avoids an added step, the expense of a CSE needle, and the necessity of an intentional dural puncture (14). The accidental dural puncture rate using the epidural technique has been reported to be 0.69%–4.2% (7,8). We had no inadvertent dural punctures in our study of 46 patients (with epidural catheters placed by residents in a teaching institution). If we combine the current study with our previous studies (14), our recognized dural puncture rate is 0 of 251 and our PDPH rate is 1 of 251 (0.4%).

The current study compared 20 µg of sufentanil with 100 µg of fentanyl, after a lidocaine and epinephrine test dose, in nulliparous patients. Epidural sufentanil was shown to achieve better obstetric analgesia than epidural fentanyl when added to small-dose bupivacaine; however, those investigators used a twofold larger fentanyl dose (9). The potency ratio for epidural sufentanil and fentanyl has been shown to be approximately 5:1 (10). Therefore, we chose a fivefold larger fentanyl dose than sufentanil dose in the current study, in an attempt to evaluate comparable regimens. An epidural sufentanil dose-response study revealed no significantly longer duration with doses of >20 µg (3). It is not known, however, whether larger fentanyl doses would result in longer analgesic duration.

As in our previous studies, only a minority of our patients (40%) with a "walking epidural" did in fact ambulate; however, the patients who did not ambulate were satisfied that they had the ability to move if they so desired. Furthermore, the patients who did not ambulate did not experience motor block; they simply chose not to ambulate. The number of patients ambulating at our institution has recently increased because of increased encouragement by the obstetric staff.

Despite the fact that the analgesic duration with epidural sufentanil (20 µg) was longer in a previous study (153 minutes), the mean analgesic durations with epidural fentanyl (124 minutes) and epidural sufentanil (138 minutes) in the present study compare favorably with findings from previous studies of epidural labor analgesics. The mean duration of action of 10 mL of 0.125% bupivacaine was 53 minutes (11). When epidural fentanyl (50 µg) was combined with clonidine (120 µg), the mean duration of analgesia was 80 minutes (12). When sufentanil (7.5 µg) was added to an epidural combination of 10 mL of bupivacaine at 0.125% and epinephrine at 1.25 µg/mL, the mean duration of analgesia was 99 minutes (13). In a study comparing CSE with epidural fentanyl, the mean duration of analgesia with epidural fentanyl was 83 minutes (14). This is significantly less than the analgesia in our studies of epidural opioids (1,2). However, the study population of Breen et al. (14) included both primiparous and multiparous patients. Perhaps the more homogeneous nature of our patient population (primiparous patients in early labor) resulted in a more consistent duration of analgesia.

The only significant difference between the groups was the cervical dilation at the time of redosing (greater in Group S). Despite the greater dilation at that time, the times until the patients were fully dilated were not significantly different between these groups. Therefore, whether the cervical dilation is indeed initially quicker with sufentanil (compared with fentanyl) and whether this has any clinical relevance (because the times from analgesia to full dilation are not different) remain to be determined. In our previous study comparing intrathecal sufentanil and epidural sufentanil, there was no difference in cervical dilation rates (1). A CSE combination of intrathecal sufentanil and bupivacaine was shown to result in more rapid cervical dilation, compared with epidural 0.25% bupivacaine; however, there was a shorter time from analgesia to full dilation (6). It is thus interesting to speculate that the cause of the more rapid cervical dilation in the study by Tsen et al. (6) may be partly attributable to some intrinsic characteristic of sufentanil hastening cervical dilation, rather than epidural bupivacaine slowing dilation.

A clinical concern regarding our technique could be a delay in administering additional medication to our patients when they began to experience pain. At our institution, an anesthesiologist is always in the labor suite. When patients desire additional medication, if they remain in the latent phase of labor, we usually administer 10 mL of a dilute local anesthetic (0.0625% or 0.1% bupivacaine) mixed with opioid and then begin an infusion of the same medication. If patients are in advanced labor and are unlikely to be ambulating, we may administer a more concentrated solution. Whether beginning this infusion earlier would increase motor block or improve analgesia remains to be determined.

A comparison of the costs of these analgesic medications suggests that fentanyl may be advantageous. At our institution, the acquisition cost of a 2-mL fentanyl (100 µg) ampule is $0.30 and that of a 1-mL sufentanil (50 µg) ampule is $4.25. The patient charges, at our institution, for these ampules of fentanyl and sufentanil are $1.24 and $17.63, respectively.

In conclusion, epidural fentanyl may offer several advantages, compared with sufentanil, for labor analgesia. Our results demonstrate comparable analgesia when these drugs are administered via an epidural catheter after the administration of a lidocaine and epinephrine test dose.


    Acknowledgments
 
The authors gratefully acknowledge the assistance of Charles Gibson, RN, Anne Marie Moineau, RN, and Kelly Dixon, RN, in data acquisition and analysis. The authors appreciate the secretarial assistance of Maria Colon. The authors also thank the obstetric nurses for their professional care of the patients.


    Footnotes
 
This work was submitted for presentation at the Annual Soap Meeting, 2000.


    References
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 

  1. Dunn SM, Connelly NR, Steinberg RB, et al. Intrathecal sufentanil versus epidural lidocaine with epinephrine and sufentanil for early labor analgesia. Anesth Analg 1998;87:331–5.[Abstract/Free Full Text]
  2. Connelly NR, Mainkar T, El-Mansouri M, et al. The effect of epidural clonidine added to epidural sufentanil for labor pain management. Int J Obstet Anesth 2000;9:94–8.
  3. Steinberg RB, Powell G, Hu XH, Dunn SM. Epidural sufentanil for analgesia for labor and delivery. Reg Anesth 1989;14:225–8.[ISI][Medline]
  4. Steinberg RB, Dunn SM, Dixon DE, et al. Comparison of sufentanil, bupivacaine, and their combination for epidural analgesia in obstetrics. Reg Anesth 1992;17:131–8.[ISI][Medline]
  5. Bromage PR. Epidural anesthesia. Philadelphia:WB Saunders, 1978:144.
  6. Tsen LC, Thue B, Datta S, Segal S. Is combined spinal-epidural analgesia associated with more rapid cervical dilation in nulliparous patients when compared with conventional epidural analgesia? Anesthesiology 1999;91:920–5.[ISI][Medline]
  7. Norris MC, Grieco W, Borkowski M, et al. Complication of labor analgesia: epidural versus combined spinal epidural techniques. Anesth Analg 1994;79:529–37.[Abstract/Free Full Text]
  8. Gleeson CM, Reynolds F. Accidental dural puncture rates in UK practice. Int J Obstet Anesth 1998;7:242–6.
  9. Cohen S, Amar D, Pantuck CB, et al. Epidural analgesia for labour and delivery: fentanyl or sufentanil? Can J Anaesth 1996;43:341–6.[Abstract/Free Full Text]
  10. Herman NL, Sheu KL, Van Decar TK, et al. Determination of the analgesic dose-response relationship for epidural fentanyl and sufentanil with bupivacaine 0.125% in laboring patients. J Clin Anesth 1998;10:670–7.[ISI][Medline]
  11. O’Meara ME, Gin T. Comparison of 0.125% bupivacaine with 0.125% bupivacaine and clonidine as extradural analgesia in the first stage of labor. Br J Anaesth 1993;71:651–6.[Abstract/Free Full Text]
  12. Buggy DJ, MacDowell C. Extradural analgesia with clonidine and fentanyl compared with 0.25% bupivacaine in the first stage of labour. Br J Anaesth 1996;76:319–21.[Abstract/Free Full Text]
  13. Claes B, Soetens M, Van Zundert A, Datta S. Clonidine added to bupivacaine-epinephrine-sufentanil improves epidural analgesia during childbirth. Reg Anesth Pain Med 1998;23:540–7.[ISI][Medline]
  14. Breen TW, Giesinger CM, Halpern SH. Comparison of epidural lidocaine and fentanyl to intrathecal sufentanil for analgesia in early labour. Int J Obstet Anesth 1999;8:226–30.
Accepted for publication April 27, 2000.




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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