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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAllied Hospital Faisalabad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: Bupivacaine Infiltration Plus Standard CareExperimental treatment 2 interventions
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain Intensity

Postoperative pain intensity measured using the Visual Analog Scale (VAS; 0-10), comparing the experimental and control groups during the first 24 hours after laparoscopic abdominal surgery.

Time frame
At 1, 6, 12, and 24 hours after surgery

Secondary outcomes

1

Time to First Rescue Analgesia

Time elapsed from completion of surgery to the first administration of rescue opioid analgesia.

Time frame
Within 24 hours after surgery
2

Total Opioid Consumption

Total cumulative opioid dose administered as rescue analgesia during the first 24 hours after laparoscopic abdominal surgery.

Time frame
Within 24 hours after surgery

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Allied Hospital Faisalabad Status unavailable 38000, Faisalābad, Punjab ProvincePakistanPakistan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: