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NCT Number: NCT06722963

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Nalbuphine

Drug

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

Primary outcomes

  1. time to first analgesic request

    Time frame: 24 hours

    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

Study contacts

Contact information is provided by the study sponsor or research team.

SAMEH SAAD REYAD, resident doctor

CONTACT

[email protected]

+201271499376

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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