Acute CholecystitisPhase 4NCT07851935
Irrigation of Bupivacaine at the Surgical Bed for Postoperative Pain Relief After Laparoscopic Cholecystectomy for Acute Cholecystitis
A Phase 4 study testing Bupivacaine 0.5% and Normal Saline 0.9% in people with Acute Cholecystitis and Postoperative Pain, run by Ziauddin University at 1 site in Pakistan.
Trial summary
This study aims to compare the effectiveness of irrigation of 0.5% bupivacaine versus normal saline at the gallbladder surgical bed in reducing postoperative pain following laparoscopic cholecystectomy for acute cholecystitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Cholecystitis, Postoperative Pain
- What is being tested?
- Bupivacaine 0.5% and Normal Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to 30 Apr 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years
- Acute cholecystitis confirmed by clinical findings (epigastric pain, abdominal tenderness, positive Murphy sign), ultrasound or CT findings (gallbladder wall thickening, pericholecystic fluid), and raised total leucocyte count and C-reactive protein
- Planned for laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status I or II
- Presentation within one week of symptom onset
- Able to provide written informed consent
Who cannot join
- Known allergy to amide local anaesthetics
- Uncontrolled hypertension
- Documented psychiatric disorder
- Gallbladder empyema, mucocele, or perforation
- Conversion to open cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the effectiveness of irrigation of 0.5% bupivacaine versus normal saline at the gallbladder surgical bed in reducing postoperative pain following laparoscopic cholecystectomy for acute cholecystitis. Postoperative pain remains a common concern despite the minimally invasive nature of laparoscopic surgery. The study evaluates pain intensity at 4, 8, and 12 hours after surgery using the Visual Analogue Scale (VAS).
Read the detailed description
Laparoscopic cholecystectomy is the standard treatment for acute cholecystitis. Although associated with reduced surgical trauma and shorter hospital stays, postoperative pain remains a significant challenge. Pain may arise from port-site trauma, visceral irritation, and diaphragmatic irritation.
Bupivacaine is a long-acting amide local anesthetic that blocks voltage-gated sodium channels and may provide prolonged postoperative analgesia. This quasi-experimental study will compare irrigation of 20 mL of 0.5% bupivacaine versus 20 mL normal saline applied to the gallbladder bed following laparoscopic cholecystectomy. Postoperative pain will be assessed at 4, 8, and 12 hours using VAS scores.
The findings may contribute to improved postoperative pain management protocols and reduced analgesic requirements following laparoscopic cholecystectomy.
- Conditions
- Acute Cholecystitis, Postoperative Pain
- Being tested
- Bupivacaine 0.5%, Normal Saline 0.9%
- Medical subject headings
- Cholecystitis, Acute, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.5%Drug
20 mL of 0.5% bupivacaine irrigated over the gallbladder bed through the lateral-most port after specimen retrieval, before desufflation and port closure.
Normal Saline 0.9%Drug
20 mL of 0.9% sodium chloride irrigated over the gallbladder bed using the same technique and timing as the bupivacaine group.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Irrigation Group | Placebo comparator | Patients received 20 mL of 0.9% normal saline irrigated over the gallbladder bed using the same technique and timing as the bupivacaine group. Postoperative analgesia was standardized with scheduled intravenous non-steroidal anti-inflammatory drugs, with weak opioids as rescue. Receives: Drug: Normal Saline 0.9% |
| Bupivacaine Irrigation Group | Experimental | Patients received 20 mL of 0.5% bupivacaine irrigated over the gallbladder bed through the lateral-most port immediately after specimen retrieval, before desufflation and port closure. Postoperative analgesia was standardized with scheduled intravenous non-steroidal anti-inflammatory drugs, with weak opioids as rescue. Receives: Drug: Bupivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity at 12 Hours
Pain intensity measured on a 0-10 Visual Analogue Scale (VAS), where 0 means no pain and 10 means the worst imaginable pain. Lower scores indicate less pain.
Measured: 12 hours after surgery
Secondary outcomes (1)
Number of Participants With Adverse Effects
Local anaesthetic toxicity or allergic reaction attributable to the irrigated solution.
Measured: Up to 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Umar Akbar Khan, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851935
- Sponsor's protocol ID
- 11150925UASUR
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data on the study outcomes (Visual Analogue Scale pain scores) and baseline characteristics will be shared on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irrigation of Bupivacaine at the Surgical Bed for Postoperative Pain Relief After Laparoscopic Cholecystectomy for Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT07851935
- Acronym / sponsor ID
- 11150925UASUR
- Conditions
- Acute Cholecystitis, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 1 Oct 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 study aims to compare the effectiveness of irrigation of 0.5% bupivacaine versus normal saline at the gallbladder surgical bed in reducing postoperative pain following laparoscopic cholecystectomy for acute cholecystitis. Postoperative pain remains a common concern despite the minimally invasive nature of laparoscopic surgery. The study evaluates pain intensity at 4, 8, and 12 hours after surgery using the Visual Analogue Scale (VAS).
Detailed description
Laparoscopic cholecystectomy is the standard treatment for acute cholecystitis. Although associated with reduced surgical trauma and shorter hospital stays, postoperative pain remains a significant challenge. Pain may arise from port-site trauma, visceral irritation, and diaphragmatic irritation.
Bupivacaine is a long-acting amide local anesthetic that blocks voltage-gated sodium channels and may provide prolonged postoperative analgesia. This quasi-experimental study will compare irrigation of 20 mL of 0.5% bupivacaine versus 20 mL normal saline applied to the gallbladder bed following laparoscopic cholecystectomy. Postoperative pain will be assessed at 4, 8, and 12 hours using VAS scores.
The findings may contribute to improved postoperative pain management protocols and reduced analgesic requirements following laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Irrigation Group | Placebo comparator | Drug: Normal Saline 0.9%Patients received 20 mL of 0.9% normal saline irrigated over the gallbladder bed using the same technique and timing as the bupivacaine group. Postoperative analgesia was standardized with scheduled intravenous non-steroidal anti-inflammatory drugs, with weak opioids as rescue. |
| Bupivacaine Irrigation Group | Experimental | Drug: Bupivacaine 0.5%Patients received 20 mL of 0.5% bupivacaine irrigated over the gallbladder bed through the lateral-most port immediately after specimen retrieval, before desufflation and port closure. Postoperative analgesia was standardized with scheduled intravenous non-steroidal anti-inflammatory drugs, with weak opioids as rescue. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 60 years
- Acute cholecystitis confirmed by clinical findings (epigastric pain, abdominal tenderness, positive Murphy sign), ultrasound or CT findings (gallbladder wall thickening, pericholecystic fluid), and raised total leucocyte count and C-reactive protein
- Planned for laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status I or II
- Presentation within one week of symptom onset
Key exclusion criteria (5 listed)
- Known allergy to amide local anaesthetics
- Uncontrolled hypertension
- Documented psychiatric disorder
- Gallbladder empyema, mucocele, or perforation
- Conversion to open cholecystectomy
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 |
|---|---|---|
| Bupivacaine 0.5%20 mL of 0.5% bupivacaine irrigated over the gallbladder bed through the lateral-most port after specimen retrieval, before desufflation and port closure. | Drug | Bupivacaine Irrigation Group |
| Normal Saline 0.9%20 mL of 0.9% sodium chloride irrigated over the gallbladder bed using the same technique and timing as the bupivacaine group. | Drug | Normal Saline Irrigation Group |
Primary outcome
Postoperative Pain Intensity at 12 Hours
Time frame: 12 hours after surgery
Pain intensity measured on a 0-10 Visual Analogue Scale (VAS), where 0 means no pain and 10 means the worst imaginable pain. Lower scores indicate less pain.
1 secondary outcome
Number of Participants With Adverse Effects
Time frame: Up to 12 hours after surgery
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 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data on the study outcomes (Visual Analogue Scale pain scores) and baseline characteristics will be shared on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bupivacaine 0.5% and Normal Saline 0.9% in people with Acute Cholecystitis and Postoperative Pain, run by Ziauddin University 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 6 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: finished, as of the sponsor's last update on 1 Oct 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?
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?
Postoperative Pain Intensity at 12 Hours (time frame: 12 hours 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 1 Oct 2026.