Effect of Intraperitoneal Dexmedetomidine Added to Bupivacaine 0.25% Versus Bupivacaine Alone on Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy

Summary

Laparoscopic cholecystectomy (LC) is the preferred surgical technique for the management of cholelithiasis owing to its advantages over open surgery, including reduced postoperative pain, shorter hospital stay, and faster recovery. Nevertheless, postoperative pain-particularly in the early postoperative period-remains a clinical challenge and may lead to increased analgesic requirements, delayed ambulation, and prolonged hospitalization. Postoperative pain after LC is multifactorial, resulting from peritoneal irritation, pneumoperitoneum-induced diaphragmatic stretching, and residual intraperitoneal carbon dioxide.

Intraperitoneal instillation of local anesthetics has been widely incorporated into multimodal analgesic strategies to reduce postoperative pain and opioid consumption after laparoscopic surgery. Bupivacaine is commonly used for this purpose; however, its limited duration of action has prompted the use of adjuvants to enhance analgesic efficacy. Dexmedetomidine, a selective α2-adrenergic agonist, possesses analgesic, sedative, and opioid-sparing properties with minimal respiratory depression, making it a promising adjunct to local anesthetics.

This randomized, double-blinded clinical trial was conducted at Ain Shams University Hospitals to compare the analgesic efficacy and safety of intraperitoneal dexmedetomidine combined with bupivacaine versus bupivacaine alone in patients undergoing elective laparoscopic cholecystectomy. Thirty adult patients with ASA physical status I-II were randomly allocated into two equal groups. Group A received intraperitoneal bupivacaine 0.25%, while Group B received intraperitoneal bupivacaine 0.25% combined with dexmedetomidine 0.5 µg/kg, instilled over the gallbladder bed at the end of surgery.

The primary outcome was postoperative pain intensity assessed using the Visual Analog Scale (VAS) over the first 24 hours. Secondary outcomes included hemodynamic parameters, oxygen saturation, time to first rescue analgesia, total opioid consumption, and incidence of postoperative adverse events.

The addition of dexmedetomidine to intraperitoneal bupivacaine significantly reduced postoperative pain scores during the early postoperative period, prolonged the time to first rescue analgesia, and markedly decreased opioid consumption without compromising respiratory function. Hemodynamic changes were mild and clinically acceptable, and adverse events were comparable between groups.

In conclusion, intraperitoneal dexmedetomidine combined with bupivacaine provides superior postoperative analgesia and an opioid-sparing effect compared with bupivacaine alone following laparoscopic cholecystectomy, with an acceptable safety profile.

Conditions

• Postoperative Pain Management
• Cholelithiasis
• Laparoscopic Cholecystectomy

Interventions

DRUG

Bupivacaine 0.25% intraperitoneal

Patients receive 20 mL of 0.25% bupivacaine instilled intraperitoneally across the gallbladder bed at the end of laparoscopic cholecystectomy. Standard anesthesia and perioperative care are maintained for all participants.

DRUG

Bupivacaine 0.25% + Dexmedetomidine 0.5 µg/kg intraperitoneal

Patients receive 20 mL of 0.25% bupivacaine combined with 0.5 µg/kg dexmedetomidine instilled intraperitoneally across the gallbladder bed at the end of laparoscopic cholecystectomy. Standard anesthesia and perioperative care are maintained.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Principal Investigators

• Mariam K Habib, MD · Ain Shams University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-02

Primary Completion

2025-09-01

Completion

2025-09-21

Countries

• Egypt

Study Locations