LAPAROSCOPIC CHOLECYSTECTOMYNCT06560892
Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine
A study testing Bupivacaine injection and Dexmedetomidine injection in people with LAPAROSCOPIC CHOLECYSTECTOMY, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- LAPAROSCOPIC CHOLECYSTECTOMY
- What is being tested?
- Bupivacaine injection and Dexmedetomidine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either gender
- Aged between 20 and 70 years
- ASA (American Society of Anesthesiologists Classification) physical status I and II
- Undergoing Laparoscopic Cholecystectomy under general anesthesia
Who cannot join
- Patients sensitive to local anesthetics
- Patients with acute cholecystitis, choledocholithiasis, or ascending cholangitis (temperature≥38.6°C, serum bilirubin≥1.2mg/dl, and ultrasound showing common bile duct diameter of ≥1cm).
- Patients with uncontrolled diabetes (FBS≥110 mg/dl)
- Uncontrolled blood pressure (SBP≥140 mmHg)
- Ischemic heart disease (EF≤40%)
- Pulmonary dysfunction (FEV≤70 percent of normal)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Quaid-e-Azam Medical College
Bahawalpur, Punjab Province, 06318
About this study
Official title: Comparison Between Mean Duration of Post-operative Analgesia of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine Following Laparoscopic Cholecystectomy
For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. This study was performed with the objective of comparing the mean duration of analgesia of intraperitoneal bupivacaine with dexmedetomidine to intraperitoneal bupivacaine alone in patients undergoing laparoscopic cholecystectomy.
- Conditions
- LAPAROSCOPIC CHOLECYSTECTOMY
- Being tested
- Bupivacaine injection, Dexmedetomidine injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine injectionDrug
Also called Local anesthetic
patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline.
Dexmedetomidine injectionDrug
Also called Local anesthetic
Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group | Experimental | Patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline Receives: Drug: Bupivacaine injection |
| Bupivacaine + Dexmedetomidine group | Experimental | Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml Receives: Drug: Bupivacaine injection; Drug: Dexmedetomidine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
The duration of postoperative analgesia was calculated as the time in minutes starting after the dressing of the patient in the operation room until the patient had a VAS≥3.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Collaborators
- Bahawal Victoria Hospital Bahawalpur
- Responsible party
- Principal investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Qazi Anees, FCPS, Principal investigator, Bahawal Victoria Hospital BahawalpurSyed Shakeel Ahmed, FCPS, Principal investigator, Shahida Islam Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560892
- Sponsor's protocol ID
- DRQAZIANEESBVH
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers on a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Mean Duration of Post-operative Analgesia of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine Following Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06560892
- Acronym / sponsor ID
- DRQAZIANEESBVH
- Conditions
- LAPAROSCOPIC CHOLECYSTECTOMY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Collaborators
- Bahawal Victoria Hospital Bahawalpur
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Aug 2024 (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.
For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. This study was performed with the objective of comparing the mean duration of analgesia of intraperitoneal bupivacaine with dexmedetomidine to intraperitoneal bupivacaine alone in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group | Experimental | Drug: Bupivacaine injectionPatients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline |
| Bupivacaine + Dexmedetomidine group | Experimental | Drug: Bupivacaine injection, Drug: Dexmedetomidine injectionPatients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of either gender
- Aged between 20 and 70 years
- ASA (American Society of Anesthesiologists Classification) physical status I and II
- Undergoing Laparoscopic Cholecystectomy under general anesthesia
Key exclusion criteria (6 listed)
- Patients sensitive to local anesthetics
- Patients with acute cholecystitis, choledocholithiasis, or ascending cholangitis (temperature≥38.6°C, serum bilirubin≥1.2mg/dl, and ultrasound showing common bile duct diameter of ≥1cm).
- Patients with uncontrolled diabetes (FBS≥110 mg/dl)
- Uncontrolled blood pressure (SBP≥140 mmHg)
- Ischemic heart disease (EF≤40%)
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 injectionAlso: Local anestheticpatients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline. | Drug | Bupivacaine + Dexmedetomidine group, Bupivacaine group |
| Dexmedetomidine injectionAlso: Local anestheticPatients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml. | Drug | Bupivacaine + Dexmedetomidine group |
Primary outcome
Duration of analgesia
Time frame: 24 hours
The duration of postoperative analgesia was calculated as the time in minutes starting after the dressing of the patient in the operation room until the patient had a VAS≥3.
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 21 Aug 2024.
- Individual participant dataSharing planned: No. Data can be shared with other researchers on a reasonable request
Related trials for LAPAROSCOPIC CHOLECYSTECTOMY
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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.
Qazi Anees, FCPS principal investigator
Bahawal Victoria Hospital Bahawalpur
Syed Shakeel Ahmed, FCPS principal investigator
Shahida Islam Teaching Hospital
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 injection and Dexmedetomidine injection in people with LAPAROSCOPIC CHOLECYSTECTOMY, run by RESnTEC, Institute of Research 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 4 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 21 Aug 2024. 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?
Duration of analgesia (time frame: 24 hours). 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 21 Aug 2024.