Comparison of the Efficacy of Intraperitoneal Instillation of Fentanyl Versus Nalbuphine as Adjuvants to Bupivacaine for Postoperative Pain Relief in Patients Undergoing Laparoscopic Cholecystectomy

Overview

Given the complexity of postoperative pain following laparoscopic surgery, specialists recommend a multimodal approach to effective analgesic management . The origin of pain after LC is multifactorial and complex in nature. Pain arising from incision sites is parietal pain, whereas pain from the gall bladder bed is mainly visceral in nature, and shoulder pain is mainly referred owing to the residual CO2 irritating the diaphragm. Various strategies have been employed for pain relief after laparoscopic procedures, including the use of intraperitoneal local anesthetics, either alone or in combination with opioid analgesics. the efficacy of intraperitoneal instillation of fentanyl versus nalbuphine as adjuvants to Bupivacaine for postoperative pain relief in patients undergoing laparoscopic cholecystectomy

Detailed description

Laparoscopic cholecystectomy (LC) is recognized as the gold standard for managing gallbladder stones due to its numerous advantages over open surgery . These benefits include quicker and easier recovery, reduced operative morbidity, less postoperative pain, shorter convalescence, and overall lower costs

Intraperitoneal administration of local anesthetics is used by many surgeons as a method to provide effective pain relief while minimizing the adverse effects of systemic analgesics, including NSAIDs and opioids. The rationale for this route of administration is that the local anesthetics will block the visceral nociceptive conduction from peritoneum. In addition, systemic absorption from the large peritoneal surface may occur, providing additional mechanism of analgesia . This technique was first evaluated in patients undergoing gynecological laparoscopy and showed reduction in postoperative shoulder pain . With the possibility that a similar analgesic effect might be achieved in LC, several trials assessing the efficacy of Intraperitoneal local anesthetics in LC were carried out with conflicting results, regarding severity of postoperative pain, duration of analgesia, and total analgesic consumption in 24 h. The difference in outcome of studies on instillation of local anesthetics may result from dose, volume, or concentration of the drug; timing of instillation (before or after surgery); site of administration (subdiaphragmatic, over gall bladder bed, and/or port infiltration); and instillation in Trendelenberg's versus supine position .

Fentanyl and nalbuphine are two widely used opioids considered for pain management . Fentanyl is a potent synthetic opioid similar to morphine but produces analgesia to a greater extent. This robust pharmacologic agent is typically 50 to 100 times more potent than morphine . it is renowned for its rapid onset and strong analgesic properties. It is extensively used in clinical settings to manage acute pain .

On the other hand, nalbuphine, a mixed agonist-antagonist opioid, acts as an antagonist at μ-receptors and agonist at k-receptors that work reasonably potent analgesia. It offers effective pain relief, particularly with a lower risk of respiratory depression. It also provides prolonged analgesia and is associated with fewer side effects, such as pruritus, nausea, and vomiting, than fentanyl .

This route of administration is noninvasive, simple to perform, does not involve additional neuraxial block, and is particularly suited for the practice of ambulatory anesthesia. However, duration of analgesia may be limited for few hours. So, addition of adjuvants such as narcotics, α2 agonists, or NSAIDs has been proposed to prolong the postoperative analgesia

Interventions

• Drug fentanyl
  Fentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose is 50 micrograms is commonly added to the local anesthetic solution.
• Drug Nalbuphine
  Nalbuphine in doses ranging from 10 mg have been studied as adjuvants to bupivacaine

Primary outcome measures

• time to first analgesic request [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

• Age >18 years
• Both sex
• Patients who were in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)

Exclusion criteria

• • Patient's refusal.

• body mass index (BMI) ≥40 kg/m2.
• History of hypersensitivity to the drugs being evaluated
• Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
• chronic use of opioids and opioid addiction
• Patients with acute cholecystitis
• Carcinoma of gall bladder
• Pregnant female
• Bleeding disorders

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Laisalmi M, Koivusalo AM, Valta P, Tikkanen I, Lindgren L. Clonidine provides opioid-sparing effect, stable hemodynamics, and renal integrity during laparoscopic cholecystectomy. Surg Endosc. 2001 Nov;15(11):1331-5. doi: 10.1007/s004640090126. Epub 2001 Aug 16. PMID 11727145
• Khodorova A, Navarro B, Jouaville LS, Murphy JE, Rice FL, Mazurkiewicz JE, Long-Woodward D, Stoffel M, Strichartz GR, Yukhananov R, Davar G. Endothelin-B receptor activation triggers an endogenous analgesic cascade at sites of peripheral injury. Nat Med. 2003 Aug;9(8):1055-61. doi: 10.1038/nm885. Epub 2003 Jun 29. PMID 12847519
• Kuhry E, Jeekel J, Bonjer HJ. Effect of laparoscopy on the immune system. Semin Laparosc Surg. 2004 Mar;11(1):37-44. doi: 10.1177/107155170401100107. PMID 15094977

Identifiers

NCT: NCT06722963 · fentanyl vs nalbuphine cholecy

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗