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

NCT07388251 | Completed

• 1 other identifier: FMASU MS 180/ 2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Laparoscopic Cholecystectomy; Postoperative Pain Management; Cholelithiasis

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity measured by Visual Analog Scale (VAS)

  Pain intensity will be assessed using the 10-point Visual Analog Scale (VAS) at multiple time points: At the entry to the PACU, and at 1, 2, 4, 6, 8, 16, and 24 hours postoperatively. VAS scoring: 0 = no pain, 2-4 = mild pain, 4-6 = moderate pain, 6-8 = severe pain, 8-10 = worst pain imaginable. The mean VAS score during the first 24 postoperative hours will serve as the primary outcome to evaluate analgesic efficacy between study groups.

  From the entry to the PACU up to 24 hours postoperatively

Secondary Outcomes (6)

• Mean arterial blood pressure

  From the intraperitoneal instillation of local anesthetics and up to 24 hours postoperatively

• Heart rate

  From the intraperitoneal instillation of local anesthetics and up to 24 hours postoperatively

• Peripheral Oxygen Saturation (SpO₂)

  From the intraperitoneal instillation of local anesthetics and up to 24 hours postoperatively

• Time to first rescue analgesia

  From the end of surgery to the administration of the first rescue analgesic.

• Total pethidine consumption after surgery

  Within the first 24 hours postoperatively

Study Arms (2)

Bupivacaine 0.25% intraperitoneal instillation

ACTIVE COMPARATOR

Patients undergo laparoscopic cholecystectomy and receive intraperitoneal bupivacaine alone. Postoperative pain, hemodynamics, and analgesic requirements are monitored to evaluate standard pain control.

Drug: Bupivacaine 0.25% intraperitoneal

Bupivacaine 0.25% + Dexmedetomidine 0.5 µg/kg intraperitoneal instillation

EXPERIMENTAL

Patients undergo laparoscopic cholecystectomy and receive intraperitoneal bupivacaine combined with dexmedetomidine. Postoperative pain, hemodynamics, and analgesic requirements are monitored to assess the added analgesic effect of dexmedetomidine.

Drug: Bupivacaine 0.25% + Dexmedetomidine 0.5 µg/kg intraperitoneal

Interventions

Bupivacaine 0.25% intraperitoneal DRUG

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.

Bupivacaine 0.25% intraperitoneal instillation

Bupivacaine 0.25% + Dexmedetomidine 0.5 µg/kg intraperitoneal DRUG

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.

Bupivacaine 0.25% + Dexmedetomidine 0.5 µg/kg intraperitoneal instillation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for laparoscopic cholecystectomy.
• ASA I and II.
• Agreement to participate in the study by the participant or his local guardian.

You may not qualify if:

• BMI less than 18 or \> 30 kg/m2.
• Psychiatric illness.
• Coagulation disorders.
• Those allergic to local anesthetics, or dexmedetomidine.
• Patients with heart block or heart rate less than 50 bpm.
• Intraoperatively, patients who will be converted into open cholecystectomy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

intensive care unit Department, Ain Shams University Hospital

Cairo, Cairo Governorate, 11517, Egypt

Location

MeSH Terms

Conditions

Cholelithiasis

Interventions

Bupivacaine; Infusions, Parenteral; Dexmedetomidine

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mariam K Habib, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Model Details: This is a prospective, randomized, double-blinded, parallel-group interventional study. Adult patients undergoing elective laparoscopic cholecystectomy are randomly assigned to receive intraperitoneal instillation of a local anesthetic solution with or without an adjuvant. Allocation is concealed using sealed opaque envelopes, and both patients and postoperative assessors are blinded. All participants undergo standardized anesthetic and surgical procedures. Postoperative assessments, including hemodynamic monitoring and pain evaluation using the Visual Analog Scale, are performed at predefined intervals to assess the effects of the intervention. The study evaluates the analgesic efficacy and safety of the tested solutions while maintaining consistent perioperative care.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 5, 2026
• Study Start: March 2, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 21, 2025
• Last Updated: February 5, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start Date: Upon publication of the study results. End Date: 5 years after publication.
• Access Criteria: Qualified researchers who provide a methodologically sound proposal and have obtained approval from the study investigators will be able to access the de-identified individual participant data and relevant supporting documents. Requests should be submitted via email to the corresponding author, and data will be shared under a data use agreement ensuring confidentiality and proper use.

Locations

EG (1)