CTRI Number |
CTRI/2013/03/003493 [Registered on: 18/03/2013] Trial Registered Retrospectively |
Last Modified On: |
15/03/2013 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of three methods of pain relief in patients undergoing gall bladder surgery |
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFICACY OF USG TAP BLOCK, PORT SITE INFILTRATION AND INTRAPERITONEAL INSTILLATION FOR POST- OPERATIVE ANALGESIA AFTER LAPAROSCOPIC CHOLECYSTECTOMY |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
10 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Richa Saroa |
Designation |
Assistant professor |
Affiliation |
Government medical college and Hospital, Chandigarh |
Address |
Department of Anaesthesia
Block D , Level V
GMCH
Sector 32
Chandigarh
Chandigarh CHANDIGARH 16003 India |
Phone |
919646121513 |
Fax |
|
Email |
richajayant@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Richa Saroa |
Designation |
Assistant professor |
Affiliation |
Government medical college and Hospital, Chandigarh |
Address |
Department of Anaesthesia
Block D , Level V
GMCH
Sector 32
Chandigarh
Chandigarh CHANDIGARH 16003 India |
Phone |
919646121513 |
Fax |
|
Email |
richajayant@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Richa Saroa |
Designation |
Assistant professor |
Affiliation |
Government medical college and Hospital, Chandigarh |
Address |
Department of Anaesthesia
Block D , Level V
GMCH
Sector 32
Chandigarh
Chandigarh CHANDIGARH 16003 India |
Phone |
919646121513 |
Fax |
|
Email |
richajayant@rediffmail.com |
|
Source of Monetary or Material Support
|
Available infrastructure/drug would be used |
|
Primary Sponsor
|
Name |
NIL |
Address |
Government medical college and hospital
Sector 32 B
Chandigarh, India |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Richa Saroa |
Goverment Medical college and hospital |
Department of anaesthesia and Critical care,Government Medical College & Hospital
Chandigarh Chandigarh CHANDIGARH |
919646121513
richajayant@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee,Government medical college & Hospital, Block D, Level II, Sector 32, Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
patients scheduled to undergo laparoscopic cholecystectomy, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
intraperitoneal instillation 0.375 ropivacaine |
To compare USG TAP,intraperitoneal instillation,port site infiltration for post operative pain relief with 0.375% ropivacaine in dose of 2 mg/kg in 30 ml volume saline in patients scheduled for laparoscopic cholecystectomy |
Comparator Agent |
port site infiltration 0.375 ropivacaine |
To compare USG TAP,intraperitoneal instillation,port site infiltration for post operative pain relief with 0.375% ropivacaine in dose of 2 mg/kg in 30 ml volume saline in patients in patients scheduled for laparoscopic cholecystectomy |
Intervention |
Ultrasound guided transversus abdominis plane block(USG TAP) 0.375 ropivacaine |
To compare USG TAP,intraperitoneal instillation,port site infiltration for post operative pain relief with 0.375% ropivacaine in dose of 2mg/kg body weight in 30 ml volume of normal saline in patients scheduled for laparoscopic cholecystectomy |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
• ASA physical status I-II
• Age 18-65 yrs
• Body weight 50-75 kg of either sex ( BMI - >18.5 to <25 )
|
|
ExclusionCriteria |
Details |
• History of relevant drug allergy
• Age 18yrs or 65yrs
• History of psychiatric illness , substance abuse , or medical therapies resulting in tolerance to opioids
• Acute cholecystitis or pancreatitis
• Severe cardiovascular , respiratory ,metabolic or neurological disease
• Surgery requiring postoperative intra-abdominal drainage
• Pregnancy
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare and evaluate post operative pain scores after administration of US guided TAP block, port site infiltration and intraperitoneal instillation with ropivacaine in laparoscopic cholecystectomy. |
To compare and evaluate post operative pain scores after administration of US guided TAP block, port site infiltration and intraperitoneal instillation with ropivacaine in laparoscopic cholecystectomy in the immediate post operative period and then at 10 min, 30 min, 60 min, 4 hours, 8 hrs, 12 hrs and 24 hrs. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To compare and evaluate post operative nausea and vomiting scores.
2. To calculate the total amount of rescue analgesic used in all the patients.
3. To note any side effect due to the technique or the drug used for the post operative pain relief.
|
Post operative period upto 24 hrs |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
20/12/2012 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Laparoscopic cholecystectomy is routinely performed on day care basis for treatment of symptomatic cholelithiasis.Pain in laparoscopic cholecystectomy may be substantial and arises predominantly from skin incision sites, creation of pneumoperitoneum and trauma created by cholecystectomy itself. The pain induced by laparoscopic cholecystectomy has a considerable visceral component owing to surgical handling and diaphragmatic irritation and may contribute to shoulder tip pain in one third of the patients.
Adequate postoperative analgesia in the post operative period leads to reduction in the stress response and morbidity while facilitating rehabilitation and accelerating recovery at the same time. Regional analgesic techniques provide patient comfort by reducing the pain intensity and avoiding the side effects of systemic analgesics.
Various methods have been used to alleviate pain after laparoscopic cholecystectomy which include nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, intraperitoneal infiltration of local anesthetic, thoracic epidural block, multimodal analgesia and infiltration of local anesthetic at port site.
Transversus abdominis plane (TAP) block is a regional technique that provides pain relief by blocking abdominal neural afferents through the introduction of local anesthetic into the neurofascial plane between the internal oblique and the transversus abdominis muscles thereby reducing the postoperative pain of abdominal surgeries. There are no studies presently available in literature comparing the efficacy of USG TAP block, portsite infiltration and intraperitoneal infiltration of the local anaesthetic for providing adequate post operative analgesia in patients undergoing laparoscopic cholecystectomy, hence we intend to compare the effect of 0.375% ropivacaine (3mg/kg) to provide post operative analgesia when administered either at the portsite, intraperitoneal or in TAP block in patients undergoing laparoscopic cholecystectomy |