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To Evaluate the Effect of Wound Infiltration With 0.5% Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03958513
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Monira Parveen, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief 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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: Bupivacaine Drug: 0.9% normal saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double- Blind, Controlled Trial to Evaluate the Effect of Wound Infiltration With 0.5% Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


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

Experimental: Intervention
0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy
Drug: Bupivacaine
1.5 ml 0.25% bupivacaine for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy




Primary Outcome Measures :
  1. Post-operative pain: VAS [ Time Frame: 12 hours ]
    Post-operative pain in visual analog scale ranging 0 to100

  2. Post-operative pain: rating scale [ Time Frame: 12 HOURS ]
    Post-operative pain in numerical rating scale ranging 0 to 4


Secondary Outcome Measures :
  1. Patient Satisfaction Level: questionnaire [ Time Frame: 24 hour ]
    Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present.

  2. Hospital stay [ Time Frame: 3-5 days ]
    Time frame for hospital discharge

  3. Pain during hospital discharge: VAS [ Time Frame: 3-5days ]
    visual analog scale score during hospital discharge rangibg 0-100

  4. Time taken to return to job and normal activities [ Time Frame: 15-30 days ]
  5. Assesment of quality of life: index [ Time Frame: 15th and 30th post-operative day ]
    Quality of life is measured with gastrointestinal quality of life index. there are 36 questions . it will measure quality of life after surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958513


Contacts
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Contact: Monira Parveen, MBBS 8801720010564 konica43@gmail.com
Contact: Md. Sayedur Rahman, MBBS, MPhil 01971840757 srkhasru@gmail.com

Locations
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Bangladesh
Bangabandhu Sheikh Mujib Medical University Recruiting
Dhaka, Bangladesh
Contact: Md. Sayedur Rahman, MBBS, MPhil    01971840757    srkhasru@gmail.com   
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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Responsible Party: Dr. Monira Parveen, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03958513     History of Changes
Other Study ID Numbers: BSMMU/2018/12652
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents