Postoperative PainPhase 4NCT07650760
Comparison of Intraperitoneal Bupivacaine and Saline Irrigation for Pain Relief After Laparoscopic Cholecystectomy
A Phase 4 study testing Bupivacain and Saline (0.9% NaCl) in people with Postoperative Pain, run by Wah Medical college , POF hospital at 1 site in Pakistan.
Trial summary
This randomized clinical trial compared intraperitoneal irrigation of bupivacaine(a local anesthetic) vs a control group receiving normal saline for relief of post operative pain following laparoscopic gallbladder surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacain and Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Adult consented patients of any gender aged 18 to 60 years Fit to undergo elective laparoscopic cholecystectomy
Who cannot join
- • Patients who had developed choledocholithiasis or pancreatitis pre-operatively
- Where conversion to open cholecystectomy is needed intraoperatively
- Pregnant or lactating
- Inability to express pain appropriately, like in psychiatric disorders
- With any contraindication to the use of bupivacaine or normal saline, e.g., hypersensitivity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Wah Medical College, POF Hospital Wah cantt Wāh
Wāh, Punjab Province, 47040
Muhammad Usama Tariq, MBBS, 00923405432504, tariqosama26@gmail.com
Muhammad asad Janjua, MBBS
About this study
Official title: Comparison of Intraperitoneal Bupivacaine and Normal Saline Irrigation for Postoperative Pain Relief After Laparoscopic Cholecystectomy
This randomized clinical trial compared intraperitoneal irrigation of bupivacaine(a local anesthetic) vs a control group receiving normal saline for relief of post operative pain following laparoscopic gallbladder surgery. A total of 106 patients divided into two equal groups, with one group receiving bupivacaine and the other treated using normal saline(control).Previous studies on the subject found that bupivacaine significantly reduced postoperative pain. Although conventional intravenous analgesics remain widely used, bupivacaine may be a better option, especially in difficult surgical cases.
Read the detailed description
This randomized clinical trial was conducted to compare the effectiveness of intraperitoneal bupivacaine and normal saline for relief of post operative pain following laparoscopic cholecystectomy. A total of 106 patients undergoing elective laparoscopic gallbladder surgery were enrolled and randomly assigned into two equal groups. Non-probability consecutive sampling technique will be used to recruit patients.Patients with clinical findings of choledocholithiasis/pancreatitis/cholecystitis, who need intraoperative conversion to an open procedure, are pregnant or lactating, do not have the capacity to express pain, or have any contraindication to the drugs under study, will be excluded.In Group A, the patients received intraperitoneal irrigation of bupivacaine , while in Group B, only normal saline was used. The standard procedure of laparoscopic cholecystectomy will be similar in both groups, except for the difference that group A patients will undergo intraperitoneal instillation of 500ml normal saline solution, whereas those allocated into group B will have peritoneal irrigation using 20ml of 10% bupivacaine solution diluted in 480ml of normal saline to make a 500ml irrigation solution at the time of peritoneal closure. To ensure double blinding, the primary surgeon and patient will be blinded to the type of solution used. The time of extubation will be noted, which will be used to determine the duration of analgesia. Patients will be followed up for VAS scores at time intervals of 1, 2, 4, 6, 12, and 24 hours postoperatively. When the patient complains of pain, intravenous tramadol of 37.5mg mixed with an antiemetic will be administered.To reduce confounding, all procedures are done by the same consultant surgeon; no additional postoperative analgesic advised, and a blinded surgeon will evaluate the patient for the pain scores at these intervals, with due recording of the dosages of rescue analgesics and duration of analgesia.Past literature has provided some insight into the efficacy of bupivacaine in reducing postoperative pain, but existing evidence is not enough to establish clinical practice guidelines. Our study has the rationale of strengthening the existing body of evidence by extending the research.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacain, Saline (0.9% NaCl)
- Keywords
- laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called Group A
In group A intraperitoneal bupivacaine is used for pain relief
Saline (0.9% NaCl)Drug
Also called Group B
In group B intraperitoneal saline is used for pain relief as placebo.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : group A: bupivacaine | Experimental | Group A is the arm where patients have received intraperitoneal bupivacaine during laparoscopic gallbladder surgery, and their post operative pain is compared . Receives: Drug: Bupivacain |
| Placebo : group B: saline | Placebo comparator | Placebo : group B: saline Group B is the arm where patients have received only intraperitoneal normal saline . Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain relief
The study primarily aimed to compare post operative pain relief following intraperitoneal irrigation of bupivacaine vs normal saline.
Measured: From the completion of the procedure til one hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- This study is a prospective, parallel-group randomized controlled trial (RCT) designed to compare two different techniques for achieving post operative pain relief following laparoscopic cholecystectomy.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wah Medical college , POF hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650760
- Sponsor's protocol ID
- WMC/ERC/IRB/134
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraperitoneal Bupivacaine and Normal Saline Irrigation for Postoperative Pain Relief After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07650760
- Acronym / sponsor ID
- WMC/ERC/IRB/134
- Conditions
- Postoperative Pain
- Keywords
- laparoscopic cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Wah Medical college , POF hospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jun 2026 (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 randomized clinical trial compared intraperitoneal irrigation of bupivacaine(a local anesthetic) vs a control group receiving normal saline for relief of post operative pain following laparoscopic gallbladder surgery. A total of 106 patients divided into two equal groups, with one group receiving bupivacaine and the other treated using normal saline(control).Previous studies on the subject found that bupivacaine significantly reduced postoperative pain. Although conventional intravenous analgesics remain widely used, bupivacaine may be a better option, especially in difficult surgical cases.
Detailed description
This randomized clinical trial was conducted to compare the effectiveness of intraperitoneal bupivacaine and normal saline for relief of post operative pain following laparoscopic cholecystectomy. A total of 106 patients undergoing elective laparoscopic gallbladder surgery were enrolled and randomly assigned into two equal groups. Non-probability consecutive sampling technique will be used to recruit patients.Patients with clinical findings of choledocholithiasis/pancreatitis/cholecystitis, who need intraoperative conversion to an open procedure, are pregnant or lactating, do not have the capacity to express pain, or have any contraindication to the drugs under study, will be excluded.In Group A, the patients received intraperitoneal irrigation of bupivacaine , while in Group B, only normal saline was used. The standard procedure of laparoscopic cholecystectomy will be similar in both groups, except for the difference that group A patients will undergo intraperitoneal instillation of 500ml normal saline solution, whereas those allocated into group B will have peritoneal irrigation using 20ml of 10% bupivacaine solution diluted in 480ml of normal saline to make a 500ml irrigation solution at the time of peritoneal closure. To ensure double blinding, the primary surgeon and patient will be blinded to the type of solution used. The time of extubation will be noted, which will be used to determine the duration of analgesia. Patients will be followed up for VAS scores at time intervals of 1, 2, 4, 6, 12, and 24 hours postoperatively. When the patient complains of pain, intravenous tramadol of 37.5mg mixed with an antiemetic will be administered.To reduce confounding, all procedures are done by the same consultant surgeon; no additional postoperative analgesic advised, and a blinded surgeon will evaluate the patient for the pain scores at these intervals, with due recording of the dosages of rescue analgesics and duration of analgesia.Past literature has provided some insight into the efficacy of bupivacaine in reducing postoperative pain, but existing evidence is not enough to establish clinical practice guidelines. Our study has the rationale of strengthening the existing body of evidence by extending the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, parallel-group randomized controlled trial (RCT) designed to compare two different techniques for achieving post operative pain relief following laparoscopic cholecystectomy.
| Arm | Type | Receives |
|---|---|---|
| Experimental : group A: bupivacaine | Experimental | Drug: BupivacainGroup A is the arm where patients have received intraperitoneal bupivacaine during laparoscopic gallbladder surgery, and their post operative pain is compared . |
| Placebo : group B: saline | Placebo comparator | Drug: Saline (0.9% NaCl)Placebo : group B: saline Group B is the arm where patients have received only intraperitoneal normal saline . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- • Adult consented patients of any gender aged 18 to 60 years Fit to undergo elective laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- • Patients who had developed choledocholithiasis or pancreatitis pre-operatively
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 |
|---|---|---|
| BupivacainAlso: Group AIn group A intraperitoneal bupivacaine is used for pain relief | Drug | Experimental : group A: bupivacaine |
| Saline (0.9% NaCl)Also: Group BIn group B intraperitoneal saline is used for pain relief as placebo. | Drug | Placebo : group B: saline |
Primary outcome
Post operative pain relief
Time frame: From the completion of the procedure til one hour after surgery
The study primarily aimed to compare post operative pain relief following intraperitoneal irrigation of bupivacaine vs normal saline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
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 and Saline (0.9% NaCl) in people with Postoperative Pain, run by Wah Medical college , POF hospital 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 5 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Asad Janjua, MBBS (00923351589093, asad24871@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain relief (time frame: From the completion of the procedure til one hour after surgery). 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 16 Jun 2026.