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CTRI Number  CTRI/2015/05/005803 [Registered on: 22/05/2015] Trial Registered Retrospectively
Last Modified On: 22/05/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of ANALGESIC EFFECACY OF ULTRASOUND GUIDED ABDOMINAL BLOCK WITH EPIDURAL ANALGESIA IN PATIENTS UNDERGOING LOWER ABDOMINAL GYNAECOLOGICAL PROCEDURES 
Scientific Title of Study   RANDOMISED CONTROL TRIAL TO COMPARE THE ANALGESIC EFFECT OF ULTRASOUND GUIDED TRANSVERSUS ABDOMINUS PLANE BLOCK WITH EPIDURAL ANALGESIA IN PATIENTS UNDERGOING LOWER ABDOMINAL GYNAECOLOGICAL PROCEDURES 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeetinder Makkar 
Designation  Assistant Professor 
Affiliation  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA 
Address  DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER, SECTOR 12 CHANDIGARH
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE PGIMER, sector 12,CHANDIGARH
Chandigarh
CHANDIGARH
160047
India 
Phone    
Fax    
Email  jeet1516@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jeetinder Makkar 
Designation  Assistant Professor 
Affiliation  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA 
Address  DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER, SECTOR 12, CHANDIGARH
DEPARTMENT OFANAESTHESIA AND INTENSIVE CARE PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160047
India 
Phone  9914209510  
Fax    
Email  jeet1516@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jeetinder Makkar 
Designation  Assistant Professor 
Affiliation  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH, INDIA 
Address  TF14, PGIMER, Sector 12
DEPARTMENT OFANAESTHESIA AND INTENSIVE CARE PGIMER, CHANDIGARH

CHANDIGARH
160047
India 
Phone    
Fax    
Email  jeet1516@gmail.com  
 
Source of Monetary or Material Support  
post graduate institute of medical education & research, Chandigarh 
 
Primary Sponsor  
Name  Post Graduate Institue of Medical education research 
Address  PGIMER, SECTOR 12, CHANDIGARH 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
AJAY PADMANABANR  DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE PGIMER  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ajay   Post graduate institute of medical education and research  Department of Anesthesia, 4th Floor, Nehru Hospital
Chandigarh
CHANDIGARH 
7087009510

nscjk2006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients undergoing lower abdominal gynecological surgeries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Patients will receive TAP block with 20ml of 0.9% normal saline 
Intervention  Group TAP  Ultrasound guided TAP block with 20 ml of bupivacaine 0.25% on both sides after aspiration.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  ASA class I or II undergoing elective total abdominal hysterectomies  
 
ExclusionCriteria 
Details  Contraindications to epidural anesthesia (coagulopathy, local infection),History of relevant drug allergy, Uncooperative patient, Patients with BMI > 35,History of chronic pain, History of previous surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to determine the effect of transversus abdominis plane block on the quality of postoperative analgesia as assessed using visual analogue scores (VAS) both at movement (coughing) and at rest   to determine the effect of transversus abdominis plane block on the quality of postoperative analgesia as assessed using visual analogue scores (VAS) both at movement (coughing) and at rest immediately in the post operative period and then at 30min, 1,2, 4,6,12,24,and 48hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
Bedside pulmonary function tests using Wrights respirometer
 
2, 4, 12, 24 hours  
Total epidural local anaesthetic consumption in the 1st 48 hours postoperatively.   upto 48 hrs 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   30/03/2012 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Total abdominal hysterectomy is a routinely performed major surgery that results in substantial post-operative pain and discomfort.  Poorly controlled acute pain after abdominal hysterectomy is associated with increased incidence of post-operative complications like atelectasis, pneumonia, delirium, myocardial ischemia, prolonged hospital stay and an increased likelihood of chronic pain. For postoperative pain relief, non-opioid drugs, patient controlled intravenous strong opioids or central neuroaxial blockade are introduced in a stepwise fashion in response to reported pain intensity, usually combining two or more agents to provide adequate relief whilst minimizing adverse effects from any individual analgesic. Peripheral nerve blockade is an alternative method of providing pain relief, which offers excellent selective analgesia across a wide range of surgical proceduresEpidural analgesia is the gold standard analgesic technique. It is associated with lower visual analogue pain scores (VAS) and higher patient satisfaction. However   undesirable effects like motor blockade and urinary retention with increasing doses of local anaesthetics have been reported. A failure rate ranging from 17-37% has also been reported with the use of this technique. Opioids delivered using patient controlled analgesia is another modality available. Though patients may be comfortable at rest, some may experience significant pain on movement. Adverse effects like sedation, nausea, vomiting, pruritis and respiratory depression are frequently associated with this technique.  Renal toxicity, general bleeding risks are associated with use of non opioids like non steroidal anti-inflammatory drugs.

Abdominal wall incision contributes to a significant component of pain experienced by patients after abdominal surgery. A promising novel approach to post-operative analgesia is to block the sensory nerve supply to the anterior abdominal wall using transversus abdominis plane block. TAP block involves infiltration of local anaesthetic into a plane between the internal oblique and transverse abdominis muscle, thus blocking the sensory nerves before their infiltration of the muscles of anterior abdominal wall.The analgesic efficacy of TAP block has been demonstrated in different surgical procedures.  However, the analgesic efficacy of sonographically guided TAP block has not been compared with epidural analgesia previously.

We hypothesize that co-administration of sonographically guided TAP block  with continuous epidural infusion of local anesthetics as part of a multimodal analgesic technique would result in superior postoperative analgesia (lower pain scores) and better patient satisfaction following total abdominal hysterectomy.

 
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