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A Comparative Study to assess pain Control at Port Sites and Post Operative Analgesic Consumption in Patients Undergoing Elective Laparoscopic Cholecystectomy

A Comparative Study to Assess Pain Control and Post-Operative Analgesic Consumption With or Without the Infiltration of Bupivacaine at Port Sites in Patients Undergoing Elective Laparoscopic Cholecystectomy at a Tertiary Care Hospital - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104792
Enrollment
130
Registered
2026-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Patients with calculus cholecystitis undergoing laproscopic cholecystectomy: Infiltration of 20 ml of 0.5% Inj. Bupivacaine ( which is 100mg ) given once only at the end of procedure in

Sponsors

Dr B R SOYAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 65 years. 2. Patients with a preoperative diagnosis of symptomatic cholelithiasis or chronic cholecystitis. 3. Patients scheduled for elective laparoscopic cholecystectomy. 4. Patients willing to provide written informed consent. 5. Patients classified as ASA Grade I or II (American Society of Anesthesiologists Physical Status Classification) 6. Both genders will be included in the study.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing emergency cholecystectomy (e.g., acute cholecystitis, gallbladder perforation, gallstone ileus, emphysematous cholecystitis). 2. Patients with known allergy or hypersensitivity to Bupivacaine or amide-type local anesthetics. 3. Patients requiring conversion to open cholecystectomy during surgery. 4. Patients with coagulopathy or on anticoagulant/antiplatelet therapy (unless stopped appropriately pre-operatively). 5. Patients with severe hepatic, renal, or cardiac disease (e.g., ASA Grade III and above).

Design outcomes

Primary

MeasureTime frame
To compare the effectiveness of local infiltration of Bupivacaine at port sites versus no infiltration in reducing post-operative pain in patients undergoing elective laparoscopic cholecystectomy. Timepoint: Pain was assessed after every 2 hours after recovering from general anaesthesia and at 6 hours, 12 hours and 24 hours after the procedure in the recovery room using visual analogue scale

Secondary

MeasureTime frame
1.To evaluate the difference in total post operative analgesic consumption between the two groups. Pain was assessed at baseline & every 2 hours after recovery from general anaesthesia at 6,12 & 24 hours in the post operative period through visual analogue scale of 0 to 10. Timepoint: Pain was assessed at baseline & every 2 hours after recovery from general anaesthesia at 6,12 & 24 hours. Patient was then followed up 2 days, 1 week, 2 weeks, 4 weeks after surgery to know about the pain status & assesment was done. ;2. To assess the time to first rescue analgesic requirement post-operatively in both groups. Timepoint: ;3. To evaluate patient satisfaction regarding post-operative pain management. Timepoint: ;4. To assess the impact of Bupivacaine infiltration on length of hospital stay, if any. Timepoint:

Countries

India

Contacts

Public ContactDr MOHAMMED ARIF

Shimoga institute of medical sciences

native675agumbe@gmail.com9845069161

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026