| CTRI Number |
CTRI/2026/02/104792 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
A Comparative Study to assess pain Control at Port Sites and Post Operative Analgesic Consumption in Patients Undergoing Elective Laparoscopic Cholecystectomy |
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Scientific Title of Study
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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 |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B R SOYAL |
| Designation |
Junior resident |
| Affiliation |
Shimoga institute of medical sciences |
| Address |
Department of General Surgery, Shimoga Institute of Medical Sciences and McGann Hospital, Sagar Road, Mission Compound, Shimoga, Karnataka – 577201
Shimoga KARNATAKA 577201 India |
| Phone |
8971327972 |
| Fax |
|
| Email |
sunny9soy@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr MOHAMMED ARIF |
| Designation |
Professor and HOD |
| Affiliation |
Shimoga institute of medical sciences |
| Address |
Department of General Surgery, Shimoga Institute of Medical Sciences and McGann Hospital, Sagar Road, Mission Compound, Shimoga, Karnataka – 577201
Shimoga KARNATAKA 577201 India |
| Phone |
9845069161 |
| Fax |
|
| Email |
native675agumbe@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr MOHAMMED ARIF |
| Designation |
Professor and HOD |
| Affiliation |
Shimoga institute of medical sciences |
| Address |
Department of General Surgery, Shimoga Institute of Medical Sciences and McGann Hospital, Sagar Road, Mission Compound, Shimoga, Karnataka – 577201
Shimoga KARNATAKA 577201 India |
| Phone |
9845069161 |
| Fax |
|
| Email |
native675agumbe@gmail.com |
|
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Source of Monetary or Material Support
|
| Shimoga Institute of Medical Sciences and McGann teaching district Hospital, Sagar Road, Mission Compound, Shimoga, Karnataka – 577201 |
|
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Primary Sponsor
|
| Name |
Dr B R SOYAL |
| Address |
Department of General Surgery, Shimoga Institute of Medical Sciences and McGann Hospital, Sagar Road, Mission Compound, Shimoga, Karnataka – 577201 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B R SOYAL |
Shimoga institute of medical sciences and Mcgann teaching district hospital |
Shimoga Institute of Medical Sciences and McGann Hospital, Sagar Road, Mission Compound, Shimoga, Karnataka – 577201 Shimoga KARNATAKA |
8971327972
sunny9soy@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 into port sites |
| Comparator Agent |
Patients with calculus cholecystitis undergoing laproscopic cholecystectomy |
no bupivacaine injection at trocar and port sites |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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).
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
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.
|
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
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Secondary Outcome
|
| Outcome |
TimePoints |
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.
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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.
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2. To assess the time to first rescue analgesic requirement post-operatively in both groups.
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3. To evaluate patient satisfaction regarding post-operative pain management.
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4. To assess the impact of Bupivacaine infiltration on length of hospital stay, if any.
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Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sunny9soy@gmail.com].
- For how long will this data be available start date provided 21-07-2025 and end date provided 20-07-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Laparoscopic cholecystectomy (LC) has revolutionized the treatment of gallbladder diseases, offering advantages such as reduced postoperative pain, shorter hospital stays, and faster recovery compared to traditional open cholecystectomy. However, despite these advantages, postoperative pain remains a significant challenge, particularly at the port sites and due to intra-abdominal insufflation. The management of postoperative pain is crucial, as inadequate pain control can lead to delayed recovery, increased length of stay, and patient dissatisfaction. Therefore, effective analgesic strategies are integral to optimizing outcomes in patients undergoing laparoscopic surgery. Pain after laparoscopic surgery is typically classified as somatic pain, originating from the abdominal wall at the port sites, and visceral pain, resulting from the distension of the peritoneum due to insufflation. While systemic analgesics such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to manage this pain, their adverse effects—such as sedation, nausea, vomiting, and delayed gastrointestinal recovery—often limit their effectiveness. Opioid-induced side effects, in particular, remain a concern, as these drugs are known to impair the patient’s ability to return to normal activities, including early mobilization, and increase the risk of postoperative complications. To mitigate the need for systemic analgesics, regional techniques, including the local infiltration of anesthetics at port sites, have gained attention as promising alternatives. Local anesthetics such as bupivacaine have been increasingly used for their prolonged analgesic effects at the surgical site. Bupivacaine, a long-acting amide local anesthetic, provides superior analgesia by inhibiting nerve conduction through sodium channel blockade, thereby offering prolonged pain relief without systemic side effects. Local infiltration of bupivacaine at the port sites has been shown to reduce postoperative pain, minimize the consumption of analgesics, and improve patient comfort postoperatively, suggesting that it may serve as a valuable adjunct to multimodal pain management strategies in laparoscopic procedures. Although numerous studies have explored the benefits of local anesthesia in laparoscopic surgery, the literature lacks conclusive evidence regarding the efficacy of bupivacaine infiltration at port sites specifically in the context of laparoscopic cholecystectomy. Many studies have shown that local anesthetic infiltration at incision sites results in reduced pain scores and lower opioid consumption. However, variation in methodology, such as differences in anesthetic doses, surgical technique, and postoperative care protocols, has led to inconsistent findings. Furthermore, limited studies have focused on the long-term impact of local anesthetics on patient satisfaction and overall recovery, which remain important factors for improving clinical outcomes. This study aims to address this gap by evaluating the effects of bupivacaine infiltration at the port sites on postoperative pain levels, analgesic consumption, and overall patient recovery in patients undergoing elective laparoscopic cholecystectomy. By comparing two groups—one receiving local bupivacaine infiltration and the other receiving standard analgesic treatment without infiltration—this research will provide valuable insights into the role of local anesthetics in minimizing postoperative pain and enhancing recovery. Given that laparoscopic cholecystectomy is one of the most frequently performed elective surgeries worldwide, the findings of this study have the potential to refine pain management strategies and contribute to improved patient care. By providing evidence-based recommendations, this research could help establish a more effective and patient-friendly approach to postoperative pain management, minimizing opioid use, enhancing recovery, and reducing the risk of adverse effects. Furthermore, the outcomes of this study may influence clinical practice guidelines and pain management protocols in hospitals and tertiary care centers globally, advancing the quality of care provided to surgical patients.
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