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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Drug: fentanyl; Drug: Nalbuphine

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: SAMEH SAAD REYAD, resident doctor; Phone Number: +201271499376; Email: samah123@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fentanyl group; 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: 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.
Experimental: Nalbuphine group; patients will receive Nalbuphine in a Doses ranging from 10 mg have been studied as adjuvants to bupivacaine	Drug: Nalbuphine; Nalbuphine in doses ranging from 10 mg have been studied as adjuvants to bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first analgesic request	comparison of the post-operative analgesic effect regarding the time to first analgesic request of fentanyl versus nalbuphine as adjuvants to Bupivacaine in patients undergoing laparoscopic cholecystectomy	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: fentanyl; nalbuphine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Fentanyl; Nalbuphine
• Other Study ID Numbers: fentanyl vs nalbuphine cholecy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes