Laparoscopic Cholecystectomy SurgeryPhase 4NCT07409688
Pain Relief Following Laparoscopic Cholecystectomy While Comparing Intra Abdominal Versus Sub Cutaneous Local Anesthetic Administration
A Phase 4 study testing Intraoperitoneal local anesthetic administration and Sub cutaneous administration of local anesthetic in people with Laparoscopic Cholecystectomy Surgery and Analgeisa, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
Laparoscopic cholecystectomy involves removal of gallbladder through small incision ports resulting in faster recovery. Small incisions are less painful and hence local anesthesis administered can be effective for pain management. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery, Analgeisa, Local Anesthetic Infiltration
- What is being tested?
- Intraoperitoneal local anesthetic administration and Sub cutaneous administration of local anesthetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Jan 2026to 17 Jun 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ASA I and II
Who cannot join
- Allergic to local anesthetic Open cholecystectomy History of chronic pain History of abdominal surgery
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
Rawalpindi Teaching Hospital, Rawalpindi
Rawalpindi, Punjab Province
About this study
Official title: Comparative Evaluation of Analgesic Outcomes of Intra-peritoneal Versus Subcutaneous Infiltration of Bupivacaine for Laparoscopic Cholecystectomy Patients "
Laparoscopic cholecystectomy involves removal of gallbladder through small incision ports resulting in faster recovery. Small incisions are less painful and hence local anesthesis administered can be effective for pain management. This local anesthetic can be administered either within abdominal cavity or at sit of small incisions.
Read the detailed description
Laparoscopic cholecystectomy is a minimally invasive surgical procedure involving removal of the gallbladder through multiple small trocar incisions. Compared with open surgery, this approach is associated with reduced postoperative pain, shorter hospital stay, and faster recovery. Despite its minimally invasive nature, postoperative pain remains a significant concern, particularly at port sites and from intraperitoneal irritation. Local anesthetic techniques have been shown to contribute to multimodal analgesia in laparoscopic surgery. Local anesthetic agents may be administered either intraperitoneally or by infiltration at trocar insertion sites to reduce postoperative pain and opioid requirements. However, the optimal route of local anesthetic administration for effective postoperative analgesia following laparoscopic cholecystectomy remains uncertain, warranting further clinical evaluation.
- Being tested
- Intraoperitoneal local anesthetic administration, Sub cutaneous administration of local anesthetic
- Keywords
- Laparoscopic cholecystectomy, Post Operative analgesia, Local anesthetic administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperitoneal local anesthetic administrationDrug
Intraperitoneal infiltration of 20ml of 0.25% Bupivacaine will be done at the end of procedure by the surgeon.
Sub cutaneous administration of local anestheticDrug
port site infiltration of 20ml of 0.25% Bupivacaine will be done. 6ml for 10mm ports and 4ml for 5mm ports respectively.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal local anesthetic administration | Experimental | Not described Receives: Drug: Intraoperitoneal local anesthetic administration |
| Sub cutaneous local anesthetic administration | Active comparator | Not described Receives: Drug: Sub cutaneous administration of local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post opestive pain score
Measured: This will be measured using Visual Analog score upon arrival at post anesthesia care unit labelled as Time 0 then at time intervals 3h,6h, 12h and 24 hours post operatively
Rescue analgesia demand
Measured: This will be the number of patients requiring resuce analgesia in 24h post operative period. Rescue analgesia will be administered if VAS score >4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start17 Jan 2026
- Primary completion17 Jun 2026 (estimated)
- Study completion17 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimrah Iqbal, Rawalpindi Medical College
- Investigators
- Waqas Anjum, Study chair, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409688
- Sponsor's protocol ID
- 4726/RTH/RWP
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital ethical committee doesnt allow
Publications
Bano N, Hayat N, Saleem S, Javaid F, Rehman A, Mudassir. Comparison of intraincisional and intraperitoneal infiltration of local anaesthetic in laparoscopic cholecystectomy to control early postoperative pain. Professional Med J 2021; 28(2):192-196. https://doi.org/10.29309/TPMJ/2021.28.02.6013
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Analgesic Outcomes of Intra-peritoneal Versus Subcutaneous Infiltration of Bupivacaine for Laparoscopic Cholecystectomy Patients "
- ClinicalTrials.gov ID
- NCT07409688
- Acronym / sponsor ID
- 4726/RTH/RWP
- Keywords
- Laparoscopic cholecystectomy, Post Operative analgesia, Local anesthetic administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 17 Jun 2026 (estimated)
- Study completion
- 17 Jun 2026 (estimated)
- First posted
- 13 Feb 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.
Laparoscopic cholecystectomy involves removal of gallbladder through small incision ports resulting in faster recovery. Small incisions are less painful and hence local anesthesis administered can be effective for pain management. This local anesthetic can be administered either within abdominal cavity or at sit of small incisions.
Detailed description
Laparoscopic cholecystectomy is a minimally invasive surgical procedure involving removal of the gallbladder through multiple small trocar incisions. Compared with open surgery, this approach is associated with reduced postoperative pain, shorter hospital stay, and faster recovery. Despite its minimally invasive nature, postoperative pain remains a significant concern, particularly at port sites and from intraperitoneal irritation. Local anesthetic techniques have been shown to contribute to multimodal analgesia in laparoscopic surgery. Local anesthetic agents may be administered either intraperitoneally or by infiltration at trocar insertion sites to reduce postoperative pain and opioid requirements. However, the optimal route of local anesthetic administration for effective postoperative analgesia following laparoscopic cholecystectomy remains uncertain, warranting further clinical evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal local anesthetic administration | Experimental | Drug: Intraoperitoneal local anesthetic administration |
| Sub cutaneous local anesthetic administration | Active comparator | Drug: Sub cutaneous administration of local anesthetic |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ASA I and II
Key exclusion criteria (1 listed)
- Allergic to local anesthetic Open cholecystectomy History of chronic pain History of abdominal 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 |
|---|---|---|
| Intraoperitoneal local anesthetic administrationIntraperitoneal infiltration of 20ml of 0.25% Bupivacaine will be done at the end of procedure by the surgeon. | Drug | Intraperitoneal local anesthetic administration |
| Sub cutaneous administration of local anestheticport site infiltration of 20ml of 0.25% Bupivacaine will be done. 6ml for 10mm ports and 4ml for 5mm ports respectively. | Drug | Sub cutaneous local anesthetic administration |
Primary outcome
Post opestive pain score
Time frame: This will be measured using Visual Analog score upon arrival at post anesthesia care unit labelled as Time 0 then at time intervals 3h,6h, 12h and 24 hours post operatively
Rescue analgesia demand
Time frame: This will be the number of patients requiring resuce analgesia in 24h post operative period. Rescue analgesia will be administered if VAS score >4
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 13 Feb 2026.
- BackgroundBano N, Hayat N, Saleem S, Javaid F, Rehman A, Mudassir. Comparison of intraincisional and intraperitoneal infiltration of local anaesthetic in laparoscopic cholecystectomy to control early postoperative pain. Professional Med J 2021; 28(2):192-196. https://doi.org/10.29309/TPMJ/2021.28.02.6013
- Individual participant dataSharing planned: No. Hospital ethical committee doesnt allow
Related trials for Laparoscopic Cholecystectomy Surgery
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Not yet recruiting
Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes
Cholelithiasis
Recruiting
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic
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.
Waqas Anjum study chair
Rawalpindi Medical College
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 Intraoperitoneal local anesthetic administration and Sub cutaneous administration of local anesthetic in people with Laparoscopic Cholecystectomy Surgery and Analgeisa, run by Rawalpindi Medical College 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 1 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 13 Feb 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.
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 Nimrah Iqbal Prinicpal Investigator, MBBS (+92 335 0526611, drnimrahiqbal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post opestive pain score (time frame: This will be measured using Visual Analog score upon arrival at post anesthesia care unit labelled as Time 0 then at time intervals 3h,6h, 12h and 24 hours post operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07409688, which also lists 1 linked publication.
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 Feb 2026.