Effect of Local Anesthetic Infiltration for Postoperative Pain Control in Laparoscopic Abdominal Surgery: A Prospective Randomized Study

Sponsor
Allied Hospital Faisalabad
Study ID
NCT07747584
Status
Not Yet Recruiting

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Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Bupivacaine — DRUG
    Bupivacaine 0.5% (5 mg/mL), 20 mL diluted with 20 mL of normal saline to achieve a final concentration of 0.25% (40 mL total volume). The solution will be infiltrated equally into the planned laparoscopic trocar insertion sites before skin incision.
  • Standard Perioperative Analgesia — OTHER
    Standard perioperative analgesia according to the institutional protocol, including intravenous paracetamol 1 g every 8 hours and intravenous tramadol 50 mg administered as rescue analgesia for patients with a Visual Analog Scale (VAS) pain score ≥4 during the first 24 hours after surgery.

Study Details

Brief Summary Postoperative pain remains a common problem after laparoscopic abdominal surgery despite the minimally invasive nature of these procedures. Pain mainly arises from the trocar insertion sites, tissue manipulation, and the effects of pneumoperitoneum. Although systemic analgesics are routinely used, they may not provide adequate pain relief and can be associated with adverse effects. This prospective randomized controlled trial aims to evaluate whether pre-incisional infiltration of bupivacaine at laparoscopic trocar insertion sites reduces postoperative pain compared with standard care without local anesthetic infiltration. A total of 166 adult patients undergoing elective laparoscopic abdominal surgery will be randomly assigned to receive either local bupivacaine infiltration before skin incision or no local anesthetic infiltration. All participants will receive the same standard perioperative care and postoperative analgesic regimen. The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include the time to first rescue analgesic, total opioid consumption within the first 24 hours, and overall postoperative pain control. The results of this study may help determine whether local bupivacaine infiltration is an effective, simple, and low-cost addition to multimodal analgesia for patients undergoing laparoscopic abdominal surgery.

Key Dates

First listed
Aug 5, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
166 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bupivacaine Infiltration Plus Standard Care
    Participants undergoing elective laparoscopic abdominal surgery will receive pre-incisional infiltration of 20 mL of 0.5% bupivacaine diluted with 20 mL of normal saline (final concentration 0.25%). The solution will be equally infiltrated into the planned trocar insertion sites before skin incision in addition to standard perioperative care.
  • Active Comparator: Standard Care
    Participants undergoing elective laparoscopic abdominal surgery will receive standard perioperative care and postoperative analgesia without local bupivacaine infiltration at the trocar insertion sites.

Primary Outcome Measure

Postoperative Pain Intensity [ Time Frame: At 1, 6, 12, and 24 hours after surgery ]

Central Contacts

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