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AMBULATORY ANESTHESIA

The Effect of Ketorolac on Recovery After Anorectal Surgery: Intravenous Versus Local Administration

Margarita Coloma, MD^*, Paul F. White, PhD, MD, FANZCA^*, Philip J. Huber, Jr., MD, W. Kendall Tongier, MD^*, Kimberlie K. Dullye, MD^*, and Larry L. Duffy, MD^*

Departments of *Anesthesiology and Pain Management and Surgery, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas

Address correspondence to Dr. Paul F. White, Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center at Dallas, 5161 Harry Hines Blvd., CS2.126, Dallas, TX 75235-9068. Address e-mail to paul.white{at}email.swmed.edu

	Introduction

Top Introduction Methods Results Discussion References

 
The role of ketorolac in facilitating the recovery process after ambulatory surgery is controversial. Ketorolac, a nonsteroid antiinflammatory drug (NSAID), produces pain relief with less respiratory depression, nausea, and vomiting than opioid analgesics (1). When used as an alternative to fentanyl in outpatients undergoing laparoscopy (2), ketorolac was associated with comparable postoperative analgesia and shorter discharge times. Additionally, the combination of ketorolac and local anesthesia provided superior postoperative analgesia than either drug alone in patients undergoing knee arthroscopy procedures (3,4).

Although IV ketorolac has well known opioid-sparing properties (2–4) and even possible anesthetic-sparing qualities (5), the injection of ketorolac at the surgical site has been reported to possess varying degrees of analgesic activity (6–8). When ketorolac was administered "locally" to patients undergoing hemorrhoidectomy (6) and inguinal hernia repair (7), it decreased the postoperative pain scores and enhanced patient comfort compared with systemic morphine and IV ketorolac, respectively. However, in patients undergoing breast surgery (8), the analgesic effect of ketorolac administered at the surgical site was no more effective than IV ketorolac.

We hypothesized that the administration of ketorolac at the surgical site (local) would provide more effective postoperative analgesia than IV administration during surgery performed under local anesthesia with sedation as part of a monitored anesthesia care technique. Specifically, this study was designed to determine if a single dose of ketorolac could facilitate the recovery process after anorectal surgical procedures.

	Methods

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After obtaining institutional review board approval, 105 consenting, ASA physical status I and II outpatients scheduled for minor anorectal surgical procedures were randomly assigned to one of three study groups according to a double-blinded protocol. The three study groups consisted of Control (saline), IV ketorolac, and local ketorolac. Patients with a history of sensitivity to NSAIDs, gastrointestinal bleeding, or renal impairment were excluded.

On arrival in the operating room (OR), patients were administered diazepam emulsion, 5–10 mg IV, and then positioned in either the prone or lithotomy position. Standard monitors were placed, and oxygen (2 L/min) was administered through nasal cannulae with a CO₂ sampling port. Before the start of surgery, patients received: 1) Control group: 2 mL saline IV and 2 mL of saline mixed with the local anesthetic solution, 2) IV ketorolac group: 2 mL (60 mg) ketorolac IV and 2 mL saline mixed with the local anesthetic solution, and 3) Local ketorolac group: 2 mL saline IV and 2 mL of ketorolac (60 mg) mixed with the anesthetic solution. Propofol, 50–100 µg · kg^-1 · min^-1 IV, was administered to maintain an Observer’s Assessment of Alertness/Sedation score (9) of 2 or 3 (with 5 = awake/alert to 1 = asleep). Lidocaine gel 2% was then topically applied to the anodermal area with a large cotton applicator. Fentanyl, 25 µg IV, was administered 3–5 min before infiltrating the surgical field with 35 mL of a mixture containing lidocaine 1% and bupivacaine 0.25% with epinephrine 1/200,000 and sodium bicarbonate 4.2% (3 mL). Patient discomfort during the surgical procedure was treated with boluses of fentanyl, 25 µg IV

At the end of the surgical procedure, the propofol infusion was discontinued. If the patient achieved a fast-track score of 12 or more (i.e., awake, alert, oriented, able to purposely move extremities, with stable vital signs and minimal pain, and without intractable symptoms of nausea or vomiting) (10) on leaving the OR, they were transported directly to the day-surgery (Phase II) recovery area. The degree of postoperative pain was assessed on arrival in the recovery unit by using a descriptive scale (0=none to 3=severe) and a 10-cm linear visual analog scale (VAS), with 0 = no pain to 10 = worst pain imaginable. The postoperative analgesic requirement was assessed before discharge home. Recovery times were recorded from discontinuation of the propofol infusion until the patient was able to tolerate oral fluids, walk unassisted (ambulation time), and be discharged home.

Discharge criteria required that the patient be awake, alert, with stable vital signs on sitting and standing, and be able to walk without assistance. Voiding was not a prerequisite for discharge home. A predischarge questionnaire was completed by each patient to assess their quality of recovery (QoR) score (11). Additionally, a global QoR score (11) was also obtained from each patient before discharge home by using a 10-cm linear VAS, with 0 = poor recovery and 10 = excellent recovery. Oral hydrocodone (2.5 mg) with acetaminophen (500 mg) was prescribed for pain control after discharge. Finally, a follow-up evaluation was performed via telephone at 24 h and in the Proctology Clinic 10 days after surgery.

Data analysis consisted of Number Cruncher Statistical Systems (NCSS, Kaysville, UT) version 6.0, one-way analysis of variance for all continuous variables. When significant differences were noted, the Newman-Keuls test was performed for post hoc intergroup comparisons. The VAS scores were analyzed by using the Kruskal-Wallis test, and if a significant result was obtained, Wilcoxon’s ranked sum test was performed. Categorical (discrete) variables were analyzed by using the ² test. Data were presented as mean values ± SD, numbers, or percentages, with P values < 0.05 considered statistically significant.

	Results

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The three study groups were comparable with respect to age, weight, height, sex, ASA physical status, and HIV status (Table 1). The types of surgical procedures (e.g., hemorrhoidectomy, pilonidal cyst excision, fistulotomy, anal condyloma fulguration, and sphincterotomy) were evenly distributed among the three study groups. There were also no differences in the durations of surgery and anesthesia, the intraoperative fentanyl and propofol dosage requirements, or in the volume of intraoperative IV fluids (Table 2).

	Discussion

Top Introduction Methods Results Discussion References

 
Some colorectal surgeons have been reluctant to embrace the concept of day surgery for anorectal procedures because of the perceived difficulty in providing adequate postoperative pain relief (12). Although ketorolac decreases the need for postoperative opioid analgesic medication after ambulatory surgery (2–4), some investigators have been unable to demonstrate an improvement in clinically meaningful outcome variables [e.g., time to discharge home and QoR (13,14)]. This study provides evidence to support the concept that the use of even a single dose of ketorolac during surgery can improve the recovery profile after anorectal procedures in the ambulatory setting.

The controversy regarding the optimal route of administration of ketorolac resulted, in part, because of the differential effects of the drug on the central (spinal cord) and peripheral nervous systems (15). Reuben and Connelly (4), Reuben et al. (16), Reuben and Duprat (17), and Connelly et al. (7) have suggested that the effectiveness of ketorolac is enhanced when injected at the site of the surgical incision. For example, these investigators have reported that injecting ketorolac (60 mg) directly at the surgical site in patients undergoing inguinal hernia repair produces superior analgesia compared with the parenteral (IV) route of administration (7). Although no randomized, placebo-controlled studies using locally administered ketorolac during anorectal surgery have been published, our results suggest that injection of ketorolac at the surgical site may produce a slight advantage over systemic administration with respect to discharge time. Perhaps the slower absorption after local injection produces a more sustained analgesic effect in the postoperative period.

When administered systemically during outpatient gynecologic surgery, ketorolac was not associated with an increase in side effects and facilitated an earlier discharge compared with opioid and partial opioid agonist drugs (2). This placebo-controlled, double-blinded study demonstrated a significant reduction in postoperative pain when ketorolac 60 mg was administered either IV or locally before anorectal surgery. However, with respect to the postoperative VAS pain scores and discharge times, the only statistically significant differences compared with the Control group were in the Local ketorolac group. The differences may have been minimized because all three study groups received local anesthesia at the surgical site. Although all patients achieved fast-track criteria (18) in the OR, the ketorolac-treated patients required significantly less oral analgesic medication both before and after discharge home. More importantly, ketorolac improved the QoR from the perspective of the patient without producing side effects or postdischarge complications.

In conclusion, ketorolac (60 mg) administered either IV or locally as part of the local anesthetic mixture, improved postoperative pain control and the QoR after outpatient anorectal surgery.

	Footnotes

 
Fellowship support for MC provided in part by FUNDACYT, Ecuador.

	References

Top Introduction Methods Results Discussion References

 

1. Buckley MMT, Brogden RN. Ketorolac: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs 1990;39:86–109.[Web of Science][Medline]
2. Ding Y, White PF. Comparative effects of ketorolac, dezocine, and fentanyl as adjuvants during outpatient anesthesia. Anesth Analg 1992;75:566–71.[Abstract/Free Full Text]
3. Smith I, Shiveley RA, White PF. Effects of ketorolac and bupivacaine on recovery after outpatient arthroscopy. Anesth Analg 1992;75:208–12.[Abstract/Free Full Text]
4. Reuben SS, Connelly NR. Postoperative analgesia for outpatient arthroscopic knee surgery with intraarticular bupivacaine and ketorolac. Anesth Analg 1995;80:1154–7.[Abstract]
5. Moss JT, Baysinger CL, Boswell GW, Sayson S. Possible intraoperative anesthetic-sparing effect of parenteral ketorolac. Ann Pharmacother 1992;26:922–4.[Abstract]
6. O’Donovan S, Ferrara A, Larach S, Williamson P. Intraoperative use of Toradol^® facilitates outpatient hemorrhoidectomy. Dis Colon Rectum 1994;37:793–9.[Medline]
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8. Bosek V, Cox CE. Comparison of analgesic effect of locally and systemically administered ketorolac in mastectomy patients. Ann Surg Oncol 1996;3:62–6.[Abstract]
9. Chernik DA, Gillings D, Laine H, et al. Validity and reliability of the Observer’s Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol 1990;10:244–51.[Web of Science][Medline]
10. White PF, Song D. New criteria for fast-tracking after outpatient anesthesia: a comparison with the modified Aldrete’s scoring system. Anesth Analg 1999;88:1069–72.[Free Full Text]
11. Myles PS, Hunt JO, Nightingale CE, et al. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg 1999;88:83–90.[Abstract/Free Full Text]
12. Thompson-Fawcet MW, Cook TA, Baigrie RJ, Mortensen NJ. What patients think of day-surgery proctology. Br J Sur 1998;85:1388.[Medline]
13. Wong HY, Carpenter RL, Kopacz DJ, et al. A randomized, double-blind evaluation of ketorolac tromethamine for postoperative analgesia in ambulatory surgery patients. Anesthesiology 1993;78:6–14.[Web of Science][Medline]
14. Ding Y, Fredman B, White PF. Use of ketorolac and fentanyl during outpatient gynecologic surgery. Anesth Analg 1993;77:205–10.[Web of Science][Medline]
15. Souter A, Fredman B, White PF. Controversies in the perioperative use of non-steroidal antiinflammatory drugs. Anesth Analg 1994;79:1178–90.[Free Full Text]
16. Reuben SS, Steinberg RB, Kreitzer JM, Duprat KM. Intravenous regional anesthesia using lidocaine and ketorolac. Anesth Analg 1995;81:110–3.[Abstract]
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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