Laparoscopic CholecystectomyPhase 4BUPA-LCNCT07098429
Postoperative Pain After Instillation Of Bupivacaine During Laparoscopic Cholecystectomy
A Phase 4 study testing Bupivacain (Postoperative) and Normal (0.9%) saline in people with Laparoscopic Cholecystectomy and Post Operative Analgesia, run by Recep Tayyip Erdogan Hospital Pakistan - Muzaffargarh at 1 site in Pakistan.
Trial summary
This study aims to compare the level of postoperative pain experienced by patients undergoing laparoscopic cholecystectomy with and without the use of intraperitoneal bupivacaine. Read more about this study
- Who is it for?
- Ages 14 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy, Post Operative Analgesia, Bupivacaine
- What is being tested?
- Bupivacain (Postoperative) and Normal (0.9%) saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Jul 2024to 10 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and female patients, having age 14-70 years, admitted to undergo scheduled Laparoscopic Cholecystectomy
Who cannot join
- Patients with history of hypersensitivity to bupivacaine Acute cholecystitis Pregnancy Lactating mothers Empyema of the gallbladder and laparoscopic converted to open surgery
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Recep Tayyip Erdogan Hospital, Muzaffargarh, Pakistan
Muzaffargarh, Punjab Province
About this study
Official title: A Comparison Of Postoperative Pain With And Without Instillation Of Bupivacaine During Laparoscopic Cholecystectomy
This study aims to compare the level of postoperative pain experienced by patients undergoing laparoscopic cholecystectomy with and without the use of intraperitoneal bupivacaine. Bupivacaine, a long-acting local anesthetic, is hypothesized to reduce postoperative pain when instilled into the peritoneal cavity at the end of the procedure. The study will involve adult patients undergoing elective laparoscopic cholecystectomy and will assess pain levels using standardized pain scoring methods at various postoperative intervals. By evaluating and comparing outcomes in both groups, the study seeks to determine whether the routine use of intraperitoneal bupivacaine provides significant analgesic benefits, contributing to enhanced recovery and improved patient comfort following surgery
Read the detailed description
Laparoscopic cholecystectomy (LC) is now widely regarded as the standard treatment for gallstones due to its advantages over open surgery, including reduced postoperative pain, shorter hospital stays, and quicker recovery. Despite these benefits, many patients still experience significant pain after surgery, attributed to factors such as port-site incisions and the residual gas used during the procedure. This study was designed to assess whether the use of bupivacaine, a local anesthetic instilled into the gallbladder bed during surgery, can help in reducing postoperative pain. The objective was to compare the pain levels in patients who received bupivacaine with those who received a placebo (normal saline) during LC.
The study included both male and female patients between the ages of 14 and 70 who were scheduled for elective laparoscopic cholecystectomy. Patients were excluded if they had a known allergy to bupivacaine, were pregnant or breastfeeding, had acute cholecystitis or gallbladder empyema, or if their surgery was converted from laparoscopic to an open procedure. A total of 60 patients were enrolled and randomly divided into two groups. Group A received 20 ml of 0.25% bupivacaine instilled into the gallbladder fossa after gallbladder removal, while Group B received 20 ml of normal saline. Both groups also received standard local anesthesia at the port sites. Following surgery, pain levels were recorded at 1, 3, 6, 12, and 24 hours using a standard pain scoring system. Additionally, the time to the first request for rescue analgesia was documented.
Participants in this study might benefit from reduced postoperative pain, decreased need for additional analgesics, and a potentially quicker recovery. The risks associated with participation were minimal, limited primarily to rare allergic reactions or local discomfort due to bupivacaine. Importantly, no narcotics were used, thereby reducing risks related to sedation or dependency.
The study was conducted at Recep Tayyip Erdogan Hospital in Muzaffargarh, Pakistan. It commenced on 19 November 2024 and concluded on 10 April 2025, with a total duration of approximately five months. The authors of the study declared that no external funding was received
- Being tested
- Bupivacain (Postoperative), Normal (0.9%) saline
- Keywords
- Laparoscopic Cholecystectomy Analgesia, Gallstones, Outcomes, Postoperative Pain
- Medical subject headings
- Gallstones, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacain (Postoperative)Drug
20ml of 0.25% bupivacaine instillation in gallbladder fossa after removal of gallbladder in laparoscopic cholecystectomy this study used less amount of drug
Normal (0.9%) salineDrug
In 30 patients who underwent Laparoscopic Cholecystectomy , 20ml of 0.9% normal saline instillation in gallbladder fossa after removal of gallbladder.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Group | Placebo comparator | In 30 patients who underwent Laparoscopic Cholecystectomy , 20ml of 0.9% normal saline instillation in gallbladder fossa after removal of gallbladder Receives: Drug: Bupivacain (Postoperative); Drug: Normal (0.9%) saline |
| Bupivacaine Group | Experimental | In 30 patients who underwent Laparoscopic Cholecystectomy , 20ml of 0.25% Bupivacaine instillation in gallbladder fossa after removal of gallbladder Receives: Drug: Bupivacain (Postoperative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment after Laparoscopic Cholecystectomy
After instillation of drug, pain assessment will be done using Wong Baker Faces
Measured: Pain assessment at 1st 3rd 6th 12th and 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start11 Jul 2024
- Primary completion20 Apr 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan Hospital Pakistan - Muzaffargarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noman Yousaf, Indus Hospital and Health Network
- Investigators
- Noman Yousaf, MBBS, Principal investigator, Indus Hospital & health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098429
- Sponsor's protocol ID
- IHHN _IRB_2024_04_002
- Acronym
- BUPA-LC
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of Postoperative Pain With And Without Instillation Of Bupivacaine During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07098429
- Acronym / sponsor ID
- BUPA-LC / IHHN _IRB_2024_04_002
- Keywords
- Laparoscopic Cholecystectomy Analgesia, Gallstones, Outcomes, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan Hospital Pakistan - MuzaffargarhUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the level of postoperative pain experienced by patients undergoing laparoscopic cholecystectomy with and without the use of intraperitoneal bupivacaine. Bupivacaine, a long-acting local anesthetic, is hypothesized to reduce postoperative pain when instilled into the peritoneal cavity at the end of the procedure. The study will involve adult patients undergoing elective laparoscopic cholecystectomy and will assess pain levels using standardized pain scoring methods at various postoperative intervals. By evaluating and comparing outcomes in both groups, the study seeks to determine whether the routine use of intraperitoneal bupivacaine provides significant analgesic benefits, contributing to enhanced recovery and improved patient comfort following surgery
Detailed description
Laparoscopic cholecystectomy (LC) is now widely regarded as the standard treatment for gallstones due to its advantages over open surgery, including reduced postoperative pain, shorter hospital stays, and quicker recovery. Despite these benefits, many patients still experience significant pain after surgery, attributed to factors such as port-site incisions and the residual gas used during the procedure. This study was designed to assess whether the use of bupivacaine, a local anesthetic instilled into the gallbladder bed during surgery, can help in reducing postoperative pain. The objective was to compare the pain levels in patients who received bupivacaine with those who received a placebo (normal saline) during LC.
The study included both male and female patients between the ages of 14 and 70 who were scheduled for elective laparoscopic cholecystectomy. Patients were excluded if they had a known allergy to bupivacaine, were pregnant or breastfeeding, had acute cholecystitis or gallbladder empyema, or if their surgery was converted from laparoscopic to an open procedure. A total of 60 patients were enrolled and randomly divided into two groups. Group A received 20 ml of 0.25% bupivacaine instilled into the gallbladder fossa after gallbladder removal, while Group B received 20 ml of normal saline. Both groups also received standard local anesthesia at the port sites. Following surgery, pain levels were recorded at 1, 3, 6, 12, and 24 hours using a standard pain scoring system. Additionally, the time to the first request for rescue analgesia was documented.
Participants in this study might benefit from reduced postoperative pain, decreased need for additional analgesics, and a potentially quicker recovery. The risks associated with participation were minimal, limited primarily to rare allergic reactions or local discomfort due to bupivacaine. Importantly, no narcotics were used, thereby reducing risks related to sedation or dependency.
The study was conducted at Recep Tayyip Erdogan Hospital in Muzaffargarh, Pakistan. It commenced on 19 November 2024 and concluded on 10 April 2025, with a total duration of approximately five months. The authors of the study declared that no external funding was received
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Group | Placebo comparator | Drug: Bupivacain (Postoperative), Drug: Normal (0.9%) salineIn 30 patients who underwent Laparoscopic Cholecystectomy , 20ml of 0.9% normal saline instillation in gallbladder fossa after removal of gallbladder |
| Bupivacaine Group | Experimental | Drug: Bupivacain (Postoperative)In 30 patients who underwent Laparoscopic Cholecystectomy , 20ml of 0.25% Bupivacaine instillation in gallbladder fossa after removal of gallbladder |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients, having age 14-70 years, admitted to undergo scheduled Laparoscopic Cholecystectomy
Key exclusion criteria (2 listed)
- Patients with history of hypersensitivity to bupivacaine Acute cholecystitis Pregnancy Lactating mothers Empyema of the gallbladder and laparoscopic converted to open surgery
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacain (Postoperative)20ml of 0.25% bupivacaine instillation in gallbladder fossa after removal of gallbladder in laparoscopic cholecystectomy this study used less amount of drug | Drug | Bupivacaine Group, Normal Saline Group |
| Normal (0.9%) salineIn 30 patients who underwent Laparoscopic Cholecystectomy , 20ml of 0.9% normal saline instillation in gallbladder fossa after removal of gallbladder. | Drug | Normal Saline Group |
Primary outcome
Pain Assessment after Laparoscopic Cholecystectomy
Time frame: Pain assessment at 1st 3rd 6th 12th and 24th hour
After instillation of drug, pain assessment will be done using Wong Baker Faces
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noman Yousaf, MBBS principal investigator
Indus Hospital & health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacain (Postoperative) and Normal (0.9%) saline in people with Laparoscopic Cholecystectomy and Post Operative Analgesia, run by Recep Tayyip Erdogan Hospital Pakistan - Muzaffargarh at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment after Laparoscopic Cholecystectomy (time frame: Pain assessment at 1st 3rd 6th 12th and 24th hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.