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CompletedNCT03958513Updated Jun 1, 2020

To Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy

A Phase 2 interventional study of Bupivacaine and 0.9% normal saline in Post-operative Pain, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-01.

Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2019, registered May 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Post-operative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 58 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 126 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
58 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy

    Drug: 0.9% normal saline

  • Experimental
    Intervention

    0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy

    Drug: Bupivacaine

Interventions

  • DrugBupivacaine

    1.5 ml 0.25% bupivacaine for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy

  • Drug0.9% normal saline

    1.5 ml 0.9% NACl for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy

06

What researchers measure

Primary outcomes

  1. Post-operative pain: VAS

    Post-operative pain in visual analog scale ranging 0 to100

    Time frame: 12 hours

  2. Post-operative pain: rating scale

    Post-operative pain in numerical rating scale ranging 0 to 4

    Time frame: 12 HOURS

Secondary outcomes

  1. Patient Satisfaction Level: questionnaire

    Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present.

    Time frame: 24 hour

  2. Hospital stay

    Time frame for hospital discharge

    Time frame: 3-5 days

  3. Pain during hospital discharge: VAS

    visual analog scale score during hospital discharge rangibg 0-100

    Time frame: 3-5days

  4. Time taken to return to job and normal activities

    Time frame: 15-30 days

  5. 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.

    Time frame: 15th and 30th post-operative day

07

Study locations

1 site
  • Bangabandhu Sheikh Mujib Medical University
    Dhaka, Bangladesh
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03958513
Lead sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Responsible party
Dr. Monira Parveen (Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh) — Principal investigator
First posted
May 22, 2019
Start date
Jan 1, 2019
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Last update
Jun 1, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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