FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
Close