Post-operative PainPhase 2NCT03958513
To Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
A Phase 2 study testing Bupivacaine and 0.9% normal saline in people with Post-operative Pain, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
To evaluate the effect of wound infiltration with 0.25% Bupivacaine in laparoscopic cholecystectomy in terms of pain severity, patient satisfaction level, quality of life, hospital stay and return to job and normal activities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Bupivacaine and 0.9% normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jan 2019to 31 Jul 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia at department of surgery and department of hepatobiliary system, BSMMU
- Patients who are eligible according to ASA Ⅰ -Ⅱ
- Female or male, age ≥18 years
- Patients who are scheduled for same anesthetic technique and surgical procedure for laparoscopic cholecystectomy
- Discharge of patient between 12 hour to 36 hour after performing procedure
- Patients given consent for enrollment in study
Who cannot join
- Patients known to be allergic to certain recommended drugs
- If patients have history of psychiatric illness
- Patients on chronic analgesic therapy for any other indication
- Patients who are scheduled for different anesthetic technique and surgical procedure for laparoscopic cholecystectomy
- Duration of surgery more than 1 hour
- Patients undergoing laparoscopic cholecystectomy for complex gallbladder disease such as incidental gallbladder pancreatitis, gallstone pancreatitis, cholecystoduodenal fistula, mirizzi syndrome
- Special population group such as children, pregnant woman, patients with cirrhosis, diabetics
- Duration of operative procedure more than 1 hour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double- Blind, Controlled Trial to Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
To evaluate the effect of wound infiltration with 0.25% Bupivacaine in laparoscopic cholecystectomy in terms of pain severity, patient satisfaction level, quality of life, hospital stay and return to job and normal activities.
- Conditions
- Post-operative Pain
- Being tested
- Bupivacaine, 0.9% normal saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
1.5 ml 0.25% bupivacaine for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy
0.9% normal salineDrug
1.5 ml 0.9% NACl for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy Receives: Drug: 0.9% normal saline |
| Intervention | Experimental | 0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain: VAS
Post-operative pain in visual analog scale ranging 0 to100
Measured: 12 hours
Post-operative pain: rating scale
Post-operative pain in numerical rating scale ranging 0 to 4
Measured: 12 HOURS
Secondary outcomes (5)
Patient Satisfaction Level: questionnaire
Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present.
Measured: 24 hour
Hospital stay
Time frame for hospital discharge
Measured: 3-5 days
Pain during hospital discharge: VAS
visual analog scale score during hospital discharge rangibg 0-100
Measured: 3-5days
Time taken to return to job and normal activities
Measured: 15-30 days
Assesment of quality of life: index
Quality of life is measured with gastrointestinal quality of life index. there are 36 questions . it will measure quality of life after surgery.
Measured: 15th and 30th post-operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Jan 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Monira Parveen, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958513
- Sponsor's protocol ID
- BSMMU/2018/12652
- Status last verified
- May 2020
- First submitted
- 15 May 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double- Blind, Controlled Trial to Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03958513
- Acronym / sponsor ID
- BSMMU/2018/12652
- Conditions
- Post-operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 22 May 2019 (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 evaluate the effect of wound infiltration with 0.25% Bupivacaine in laparoscopic cholecystectomy in terms of pain severity, patient satisfaction level, quality of life, hospital stay and return to job and normal activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9% normal saline0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy |
| Intervention | Experimental | Drug: Bupivacaine0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia at department of surgery and department of hepatobiliary system, BSMMU
- Patients who are eligible according to ASA Ⅰ -Ⅱ
- Female or male, age ≥18 years
- Patients who are scheduled for same anesthetic technique and surgical procedure for laparoscopic cholecystectomy
- Discharge of patient between 12 hour to 36 hour after performing procedure
Key exclusion criteria (8 listed)
- Patients known to be allergic to certain recommended drugs
- If patients have history of psychiatric illness
- Patients on chronic analgesic therapy for any other indication
- Patients who are scheduled for different anesthetic technique and surgical procedure for laparoscopic cholecystectomy
- Duration of surgery more than 1 hour
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 |
|---|---|---|
| Bupivacaine1.5 ml 0.25% bupivacaine for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy | Drug | Intervention |
| 0.9% normal saline1.5 ml 0.9% NACl for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy | Drug | Placebo |
Primary outcome
Post-operative pain: VAS
Time frame: 12 hours
Post-operative pain in visual analog scale ranging 0 to100
Post-operative pain: rating scale
Time frame: 12 HOURS
Post-operative pain in numerical rating scale ranging 0 to 4
5 secondary outcomes
Patient Satisfaction Level: questionnaire
Time frame: 24 hour
Hospital stay
Time frame: 3-5 days
Pain during hospital discharge: VAS
Time frame: 3-5days
Time taken to return to job and normal activities
Time frame: 15-30 days
Assesment of quality of life: index
Time frame: 15th and 30th post-operative day
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 Jun 2020.
- Individual participant dataSharing planned: No
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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 2 study testing Bupivacaine and 0.9% normal saline in people with Post-operative Pain, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 8 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 Jun 2020. 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 Bangladesh. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Post-operative pain: VAS (time frame: 12 hours). 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?
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 Jun 2020.