Pain, PostoperativePhase 3NCT05264805
Effectiveness of Port Site Bupivacaine Injection in Postoperative Pain Reduction After Lap. Chole
A Phase 3 study testing 0.25% Bupivacaine in people with Pain, Postoperative, run by Hamdard University.
Trial summary
To determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- 0.25% Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Sep 2022
- Phase
- Phase 3
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of both the gender of age >18 years and <45years
- Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
- Patients with A.S.A grade I and II.
Who cannot join
- Patients with known allergic reactions to local anesthetics.
- Patients converted to open procedure.
- Patients developing intra-operative complications.
- Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.
- Patients with obesity and chronic illness.
- Patients with history of opioids, steroids, NSAIDs and alcohol use.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial of Port Site Subcutaneous Injection of Bupivacaine to Determine the Effectiveness of Postoperative Pain Relief After Laparoscopic Cholecystectomy
To determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.
Read the detailed description
The study is being done to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.
- Conditions
- Pain, Postoperative
- Being tested
- 0.25% Bupivacaine
- Keywords
- #Post operative pain, #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.
0.25% BupivacaineDrug
Also called Bupivacain
20ml of 0.25% Bupivacaine subcutaneous infiltration at port site wound.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group | Experimental | Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site Receives: Drug: 0.25% Bupivacaine |
| Placebo group | No intervention | No drug infiltration at laparoscopic port site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post laparoscopic port site pain assessment
Pain assessment by "Visual Analog Scoring system" scoring from 0 to 10, where 0 means no pain and 10 means worst possible, unbearable excruciating pain.
Measured: Pain assessment from 0hour (patient received in recovery room) till 12hours postoperatively at interval of 3hours i.e. 0,3,6,9,12 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: Study group: Patient receiving intervention i.e 20ml of 0.25% buvivacaine infiltration at laparoscopic port site. Group B: Control group: no intervention
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nida Shahid, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264805
- Sponsor's protocol ID
- N0333
- Status last verified
- Mar 2022
- First submitted
- 4 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Port Site Subcutaneous Injection of Bupivacaine to Determine the Effectiveness of Postoperative Pain Relief After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05264805
- Acronym / sponsor ID
- N0333
- Conditions
- Pain, Postoperative
- Keywords
- #Post operative pain, #laparoscopic cholecystectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 3 Mar 2022 (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.
To determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.
Detailed description
The study is being done to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A: Study group: Patient receiving intervention i.e 20ml of 0.25% buvivacaine infiltration at laparoscopic port site. Group B: Control group: no intervention
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group | Experimental | Drug: 0.25% BupivacainePatient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site |
| Placebo group | No intervention | –No drug infiltration at laparoscopic port site |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients of both the gender of age >18 years and <45years
- Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
- Patients with A.S.A grade I and II.
Key exclusion criteria (6 listed)
- Patients with known allergic reactions to local anesthetics.
- Patients converted to open procedure.
- Patients developing intra-operative complications.
- Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.
- Patients with obesity and chronic illness.
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 |
|---|---|---|
| 0.25% BupivacaineAlso: Bupivacain20ml of 0.25% Bupivacaine subcutaneous infiltration at port site wound. | Drug | Bupivacaine group |
Primary outcome
Post laparoscopic port site pain assessment
Time frame: Pain assessment from 0hour (patient received in recovery room) till 12hours postoperatively at interval of 3hours i.e. 0,3,6,9,12 hour
Pain assessment by "Visual Analog Scoring system" scoring from 0 to 10, where 0 means no pain and 10 means worst possible, unbearable excruciating pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.25% Bupivacaine in people with Pain, Postoperative, run by Hamdard University.
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: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Nida Shahid, MBBS, FCPS (+923332358698, nida-shahid2011@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post laparoscopic port site pain assessment (time frame: Pain assessment from 0hour (patient received in recovery room) till 12hours postoperatively at interval of 3hours i.e. 0,3,6,9,12 hour). 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 3 Mar 2022.