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出境医 / 临床实验 / 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 Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy

Study Description
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 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 Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

Locations
Layout table for location information
Bangladesh
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date June 1, 2020
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Patient Satisfaction Level: questionnaire [ Time Frame: 24 hour ]
    Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present.
  • Hospital stay [ Time Frame: 3-5 days ]
    Time frame for hospital discharge
  • Pain during hospital discharge: VAS [ Time Frame: 3-5days ]
    visual analog scale score during hospital discharge rangibg 0-100
  • 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 ]
    Quality of life is measured with gastrointestinal quality of life index. there are 36 questions . it will measure quality of life after surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
Official Title  ICMJE Randomized, Double- Blind, Controlled Trial to Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-operative Pain
Intervention  ICMJE
  • Drug: Bupivacaine
    1.5 ml 0.25% bupivacaine for 1 inch incision will be given 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy
    Intervention: 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
    Intervention: Drug: Bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2020) 		58
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		60
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958513
Other Study ID Numbers  ICMJE BSMMU/2018/12652
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Monira Parveen, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Sponsor  ICMJE Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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