NCT07450781

The Impact of Saline Temperature and Local Anesthetic Adjuvants on Postoperative Shoulder Pain and Inflammatory Marker Levels Following Laparoscopic Cholecystectomy

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Laparoscopic cholecystectomy has become the gold standard for the operative treatment of gallbladder disease due to its minimally invasive nature and improved patient outcomes. However, postoperative pain remains a significant concern following this procedure, affecting patient comfort, recovery, potential for same day discharge and overall satisfaction. However, visceral pain, port-site pain, and referred shoulder pain are occasionally reported in laparoscopic cholecystectomy patients . Postoperative shoulder pain is a common complication following laparoscopic cholecystectomy, often attributed to diaphragmatic irritation.

Detailed description

This study will be a randomized, double-blind, controlled trial with a factorial design, consisting of six groups based on saline temperature and the presence of local anesthetic adjuvants: Group A1: Room-temperature saline (25-30 ml/kg ) irrigation without local anesthetic. Group A2: Room-temperature saline (25-30 ml/kg l) with local anesthetic ( 0.25% bupivacaine according to body weight). Group B1: Warm saline (37°C, 25-30 ml/kg ) irrigation without local anesthetic. Group B2: Warm saline (37°C, 25-30 ml/kg) with local anesthetic (0.25% bupivacaine). Group C1: No saline irrigation. Group C2: No saline irrigation but with local anesthetic (local anesthetic instillation at trocar sites). Intervention: All of the patients will not premedicated . The anesthesia will be induced along with lidocaine 1 mg/kg, propofol 1.5 mg/kg, and rocuronium 0.6 mg/kg intravenous, and was maintained with sevoflurane (2-3%). The intraoperative and postoperative pain will be controlled with intravenous fentanyl 2-3 μg/kg. All the laparoscopic cholecystectomies (LCs) will be performed by the same team of experienced professionals. A pneumoperitoneum will be created by insufflating CO2 gas through a 10- mm trocar in the umbilicus, and will be maintained at 12 mmHg throughout the surgery. Prior to the surgery, all patients will be moved into a reverse Trendelenburg position with a left tilt (10°), and the LC will be conducted using the standard 4-port technique. After complete hemostasis, a drain insertion will be selectively performed only in cases with intraoperative bile leakage. The patients will then randomly divided into 6 groups Saline irrigation will be performed after the removal of the gallbladder but before the closure of the trocar incisions. Local anesthetic (bupivacaine: 0.25%) will be added to the saline solution in groups A2 and B2 or administered to the subdiaphragmatic area in the no-irrigation group (C2). A standardized postoperative analgesic regimen will be consisting of 8 h interval regular IV ketorolac 30mg and Patient controlled analgesia (PCA) that will be started at the PACU and continued during the first 24 h postoperatively. PCA device will be used for all patients to deliver a continuous IV infusion of 0.3 mg/h of morphine and a bolus of 1 mg IV morphine with a 20 min lockout time. Outcome Measures Primary Endpoint: Postoperative Shoulder Pain Intensity: VAS scores recorded at 6, 24, 48, and 72 hours postoperatively. Secondary Endpoints: Postoperative Abdominal Pain): Patients will rate their abdominal pain intensity on a scale of 0 (no pain) to 10 (worst imaginable pain) using, Visual Analog Scale (VAS) at 6 ,12,18,24 and 48 hours. Total Postoperative Analgesic Consumption:,Total amount of opioid and non-opioid analgesics used in the first 72 hours.Time to First Rescue Analgesic: Time from the end of surgery to the first administration of rescue analgesics (e.g., opioid).Length of Postoperative Hospital Stay: Duration from the end of surgery to discharge.Patient Satisfaction with Pain Control: Patients will complete a satisfaction questionnaire during the first 72 hours. Incidence of Postoperative Shoulder Pain: Proportion of patients reporting shoulder pain during the first 72 hours. Postoperative Nausea and Vomiting (PONV): Document the occurrence of nausea and vomiting postoperatively.Time to Return to Normal Activities: Time to return to normal daily activities, including mobility and routine tasks, measured postoperatively.Blood Levels of Inflammatory Markers: C-Reactive Protein (CRP): Measured preoperatively and at 24 and 72 hours postoperatively. Interleukin-6 (IL-6): Measured preoperatively and at 24 and 72 hours postoperatively. Blood samples will be collected and analyzed using ELISA or another validated assay

Conditions

• Shoulder Pain , Laparoscopic Cholecystectomy

Interventions

Type	Name	Description
OTHER	Room-temperature saline (25-30 ml/kg ) irrigation without local anesthetic.	Room-temperature saline (25-30 ml/kg ) irrigation without local anesthetic.
OTHER	Room-temperature saline (25-30 ml/kg l) with local anesthetic ( 0.25% bupivacaine according to body weight).	Room-temperature saline (25-30 ml/kg l) with local anesthetic ( 0.25% bupivacaine according to body weight).
OTHER	Warm saline (37°C, 25-30 ml/kg ) irrigation without local anesthetic.	Warm saline (37°C, 25-30 ml/kg ) irrigation without local anesthetic.
OTHER	Warm saline (37°C, 25-30 ml/kg) with local anesthetic (0.25% bupivacaine).	Warm saline (37°C, 25-30 ml/kg) with local anesthetic (0.25% bupivacaine).
OTHER	No saline irrigation.	No saline irrigation.
OTHER	No saline irrigation but with local anesthetic (local anesthetic instillation at trocar sites).	No saline irrigation but with local anesthetic (local anesthetic instillation at trocar sites).

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2026-03-05
• Last updated: 2026-03-17

Locations

1 site across 1 country: Egypt