CholelithiasisNCT07465406
Postoperative Pain Will be Compared in Cholecystectomy Patients: Half Receiving TAP Block and Half Without it.
A study testing Bupivacaine 0.25% and Standard Post-Operative Care in people with Cholelithiasis and Pain, Postoperative, run by Darul Sehat Hospital at 1 site in Pakistan.
Trial summary
This study compares the effectiveness of a Transversus Abdominis Plane (TAP) block in reducing post-operative pain for patients undergoing laparoscopic cholecystectomy. Sixty patients were divided into two groups: one group received a TAP block with a local anesthetic at the end of surgery, and the control group did… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cholelithiasis, Pain, Postoperative
- What is being tested?
- Bupivacaine 0.25% and Standard Post-Operative Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Mar 2025to 11 Aug 2025
- Phase
- Interventional
- 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
- Patients aged 18-60 years
- Both genders
- Patients diagnosed with Cholelithiasis in accordance with operational definition and planned to undergo Laparoscopic Cholecystectomy
Who cannot join
- Patients with ASA of ≥ 3
- Patients diagnosed with acute cholecystitis, empyema, mucocele or perforated gall bladder
- Patients planned to undergo laparoscopic cholecystectomy alongside other abdominal procedures
- Patients with body mass index of ≥ 35 Kg/m2
- Patients with history of coagulation disorders like hemophilia or those with history of anti-platelet drugs use in last 2 weeks
- Pregnant females
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Darul Sehat Hospital- Liaquat College of Medicine & Dentistry.
Karachi
About this study
Official title: Comparison Of Patients Post Operative Pain Undergoing Laparoscopic Cholecystectomy Receiving Tap Block Vs Not Receiving Tap Block
This study compares the effectiveness of a Transversus Abdominis Plane (TAP) block in reducing post-operative pain for patients undergoing laparoscopic cholecystectomy. Sixty patients were divided into two groups: one group received a TAP block with a local anesthetic at the end of surgery, and the control group did not. The main goal was to see if the TAP block significantly lowers pain scores (measured on a scale of 0 to 10) within the first 12 hours after surgery and if it reduces the need for additional pain-relief medications.
Read the detailed description
Laparoscopic cholecystectomy is the gold standard for treating symptomatic cholelithiasis; however, patients often experience significant in the early post-operative period. This randomized controlled trial (RCT) was conducted at the Department of Surgery, Liaquat College of Medicine \& Dentistry, Karachi, to evaluate the analgesic efficacy of the TAP block.
A total of 60 patients, aged 18-60 years with ASA I or II, were randomized into two equal groups (n=30 each). The intervention group received an TAP block while the control group received standard post-operative analgesia.
The primary objective was to compare the mean Visual Analog Scale (VAS) score at 12 hours post-operation. Secondary objectives included assessing the time to the first request for rescue analgesia and the type of analgesic drug used. Data were analyzed to determine if the TAP block provides superior pain control compared to conventional methods.
- Conditions
- Cholelithiasis, Pain, Postoperative
- Being tested
- Bupivacaine 0.25%, Standard Post-Operative Care
- Keywords
- Laparoscopic Cholecystectomy, TAP Block, Post Operative Pain, Gallbladder, Post Operative Opioid Consumption, Visual Analog Scale, ERAS
- Medical subject headings
- Cholelithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25%Drug
Transversus Abdominis Plane (TAP) block administered by injecting 20ml of 0.25% Bupivacaine between the internal oblique and transversus abdominis muscles.
Standard Post-Operative CareOther
Patients received the routine post-operative analgesia protocol of the hospital (e.g., IV Ketorolac or Paracetamol) without the administration of a TAP block
| Study group | Role | What they receive |
|---|---|---|
| TAP Block Group | Experimental | Patients in this group received a Transversus Abdominis Plane (TAP) block at the end of the laparoscopic cholecystectomy but before extubation. Receives: Drug: Bupivacaine 0.25% |
| Control Group (The No TAP Block Group) | Other | Patients in this group underwent laparoscopic cholecystectomy under the same general anesthesia protocol but did not receive a TAP block Receives: Other: Standard Post-Operative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Score for Pain
A subjective psychometric response scale used to measure pain intensity. It consists of a 10 cm line where 0 represents "no pain" and 10 represents "the worst pain imaginable.".
Measured: 12 hours post-operation
Secondary outcomes (1)
Time for First Request of Rescue Analgesia
The duration of time (in hours or minutes) from the end of the surgical procedure until the patient first requests additional pain medication due to inadequate pain control.
Measured: Within the first 24 hours post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start11 Mar 2025
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darul Sehat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SARAH RAUF, Darul Sehat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465406
- Sponsor's protocol ID
- DarulSehatH
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data at this time
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Patients Post Operative Pain Undergoing Laparoscopic Cholecystectomy Receiving Tap Block Vs Not Receiving Tap Block
- ClinicalTrials.gov ID
- NCT07465406
- Acronym / sponsor ID
- DarulSehatH
- Conditions
- Cholelithiasis, Pain, Postoperative
- Keywords
- Laparoscopic Cholecystectomy, TAP Block, Post Operative Pain, Gallbladder, Post Operative Opioid Consumption, Visual Analog Scale, ERAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Darul Sehat HospitalUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 11 Mar 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 compares the effectiveness of a Transversus Abdominis Plane (TAP) block in reducing post-operative pain for patients undergoing laparoscopic cholecystectomy. Sixty patients were divided into two groups: one group received a TAP block with a local anesthetic at the end of surgery, and the control group did not. The main goal was to see if the TAP block significantly lowers pain scores (measured on a scale of 0 to 10) within the first 12 hours after surgery and if it reduces the need for additional pain-relief medications.
Detailed description
Laparoscopic cholecystectomy is the gold standard for treating symptomatic cholelithiasis; however, patients often experience significant in the early post-operative period. This randomized controlled trial (RCT) was conducted at the Department of Surgery, Liaquat College of Medicine \& Dentistry, Karachi, to evaluate the analgesic efficacy of the TAP block.
A total of 60 patients, aged 18-60 years with ASA I or II, were randomized into two equal groups (n=30 each). The intervention group received an TAP block while the control group received standard post-operative analgesia.
The primary objective was to compare the mean Visual Analog Scale (VAS) score at 12 hours post-operation. Secondary objectives included assessing the time to the first request for rescue analgesia and the type of analgesic drug used. Data were analyzed to determine if the TAP block provides superior pain control compared to conventional methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block Group | Experimental | Drug: Bupivacaine 0.25%Patients in this group received a Transversus Abdominis Plane (TAP) block at the end of the laparoscopic cholecystectomy but before extubation. |
| Control Group (The No TAP Block Group) | Other | Other: Standard Post-Operative CarePatients in this group underwent laparoscopic cholecystectomy under the same general anesthesia protocol but did not receive a TAP block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 18-60 years
- Both genders
- Patients diagnosed with Cholelithiasis in accordance with operational definition and planned to undergo Laparoscopic Cholecystectomy
Key exclusion criteria (6 listed)
- Patients with ASA of ≥ 3
- Patients diagnosed with acute cholecystitis, empyema, mucocele or perforated gall bladder
- Patients planned to undergo laparoscopic cholecystectomy alongside other abdominal procedures
- Patients with body mass index of ≥ 35 Kg/m2
- Patients with history of coagulation disorders like hemophilia or those with history of anti-platelet drugs use in last 2 weeks
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 0.25%Transversus Abdominis Plane (TAP) block administered by injecting 20ml of 0.25% Bupivacaine between the internal oblique and transversus abdominis muscles. | Drug | TAP Block Group |
| Standard Post-Operative CarePatients received the routine post-operative analgesia protocol of the hospital (e.g., IV Ketorolac or Paracetamol) without the administration of a TAP block | Other | Control Group (The No TAP Block Group) |
Primary outcome
Visual Analog Scale (VAS) Score for Pain
Time frame: 12 hours post-operation
A subjective psychometric response scale used to measure pain intensity. It consists of a 10 cm line where 0 represents "no pain" and 10 represents "the worst pain imaginable.".
1 secondary outcome
Time for First Request of Rescue Analgesia
Time frame: Within the first 24 hours post-operation.
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 13 Mar 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data at this time
Related trials for Cholelithiasis
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
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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 study testing Bupivacaine 0.25% and Standard Post-Operative Care in people with Cholelithiasis and Pain, Postoperative, run by Darul Sehat 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 3 inclusion and 6 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 13 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Visual Analog Scale (VAS) Score for Pain (time frame: 12 hours post-operation). 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 13 Mar 2026.