FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/02/011666 [Registered on: 02/02/2018] Trial Registered Retrospectively
Last Modified On: 30/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   feasibility of ultrasound guided superficial cervical plexus block for managing shoulder pain during laprascopic surgery under spinal anaesthesia 
Scientific Title of Study   Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for control of shoulder tip pain during Laprascopic Surgery under Spinal Anaesthesia – A Randomised Comparative Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Archana Areti 
Designation  Senior Resident 
Affiliation  Mahathma Gandhi Medical College and Reasearch Institute 
Address  Dept of Anaesthesia, Mahathma Gandhi Medical College and research Institute pillaiyarakuppam puducherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8374237095  
Fax    
Email  archanaareti@mgmcri.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Archana Areti 
Designation  Senior Resident 
Affiliation  Mahathma Gandhi Medical College and Reasearch Institute 
Address  Dept of Anaesthesia, Mahathma Gandhi Medical College and research Institute pillaiyarakuppam puducherry


PONDICHERRY
607402
India 
Phone  8374237095  
Fax    
Email  archanaareti@mgmcri.ac.in  
 
Details of Contact Person
Public Query  
Name  Archana Areti 
Designation  Senior Resident 
Affiliation  Mahathma Gandhi Medical College and Reasearch Institute 
Address  Dept of Anaesthesia, Mahathma Gandhi Medical College and research Institute pillaiyarakuppam puducherry


PONDICHERRY
607402
India 
Phone  8374237095  
Fax    
Email  archanaareti@mgmcri.ac.in  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute Pillaiyarakuppam Puducherry - 607402 
 
Primary Sponsor  
Name  Anaesthesia Department 
Address  Mahatma Gandhi Medical College and Research Institute Pillaiyarakuppam Puducherry 607402 
Type of Sponsor  Private 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 
Archana Areti  Mahatma Gandhi Medical College and Research Institute  Department of Anaesthesia
Pondicherry
PONDICHERRY 		 8374237095

archanaareti@mgmcri.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Shoulder pain in Gynaecological Laprascopic surgeries under spinal anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  no treatment  no block 
Intervention  Ultrasound guided superficial cervical plexus block  Right sided ultrasound guided superficial block with 8ml of 0.2% Ropivacaine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. ASA physical status I and II
2. Gynaecological Laparascopic surgeries under 2hours 
 
ExclusionCriteria 
Details  1. Contraindication for spinal anaesthesia
2. Infection in the skin of the neck
3. Height less than 145cms 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
intra operative opiod requirement  2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Conversion to GA
 		 2 hours 
Diaphragmatic function Assessment by Lloyd’s method  30 minutes 
Patient satisfaction
 		 3 hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   12/06/2016 
Date of Study Completion (India) 15/03/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a randomised comparative trial, investigating the efficacy of performing ultrasound guided superficial cervical plexus block to control the shoulder tip pain, without affecting the diaphragam function, thereby improving patient comfort during laparoscopic surgery under regional anaesthesia.  The primary outcome measure includes comparing the consumption of opioid analgesic during the surgery, between the two groups, which was found to be significantly less in the study group compared to the control group.  The secondary outcome measures include the incidence of conversion to general anaesthesia in which the difference was insignificant, the assessment of diaphragmatic function using ultrasound after performance of the superficial cervical plexus block which was used to correlate the occurrence and intensity of referred shoulder pain during peritoneal insufflation and the patients were found to tolerate the procedure well and there were no complications reported. 
Close