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

NCT06722963 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: fentanyl vs nalbuphine cholecy
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Laparoscopic Cholecystectomy

Keywords

fentanyl; nalbuphine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Fentanyl group

EXPERIMENTAL

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

Nalbuphine group

EXPERIMENTAL

patients will receive Nalbuphine in a Doses ranging from 10 mg have been studied as adjuvants to bupivacaine

Drug: Nalbuphine

Interventions

fentanyl DRUG

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.

Fentanyl group

Nalbuphine DRUG

Nalbuphine in doses ranging from 10 mg have been studied as adjuvants to bupivacaine

Nalbuphine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Fentanyl; Nalbuphine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

SAMEH SAAD REYAD, resident doctor

CONTACT

+201271499376; samah123@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent anesthesiologist randomly divided the patients into 35 groups of patients each using computer-generated random numbers fentanyl group and nalbuphine group (Group F and Group N). We discreetly placed the randomization results in envelopes until the end of the study. Both nalbuphine and fentanyl are colorless liquids, and they were digitally encoded so that the researchers who were responsible for postoperative follow-up and data processing were blinded to the group allocation during the whole study period. All patients were also blinded to the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor at Anesthesia and Intensive Care Department Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12