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CTRI Number  CTRI/2020/05/025379 [Registered on: 27/05/2020] Trial Registered Prospectively
Last Modified On: 26/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To assess the effect of transversus abdominis plane (TAP) block to control pain after removal of uterus. 
Scientific Title of Study   Evaluation of transversus abdominis plane (TAP) block in multimodal approach for postoperatve analgesia in abdominal hysterectomy done under combined spinal-epidural anaesthesia- a prospective randomised double blind study 
Trial Acronym  TAP in TAH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashok Jadon 
Designation  Chief medical superintendent 
Affiliation  Tata Motors Hospital, Jamshedpur 
Address  Department of Anaesthesia and Pain Relief Service, OT complex, Tata Motors Hospital, Jamshedpur
nil
Purbi Singhbhum
JHARKHAND
831004
India 
Phone  06576695676  
Fax    
Email  jadona@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ashok Jadon 
Designation  Chief medical superintendent 
Affiliation  Tata Motors Hospital, Jamshedpur 
Address  Department of Anaesthesia and Pain Relief Service, OT complex, Tata Motors Hospital, Jamshedpur
nil
Purbi Singhbhum
JHARKHAND
831004
India 
Phone  6576695676  
Fax    
Email  jadona@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Ashok Jadon 
Designation  Chief medical superintendent 
Affiliation  Tata Motors Hospital, Jamshedpur 
Address  Department of Anaesthesia and Pain Relief Service, OT complex, Tata Motors Hospital, Jamshedpur
nil
Purbi Singhbhum
JHARKHAND
831004
India 
Phone  6576695676  
Fax    
Email  jadona@rediffmail.com  
 
Source of Monetary or Material Support  
Dr Ashok Jadon 
 
Primary Sponsor  
Name  Tata Motors Hospital 
Address  Department of Anaesthesia, OT complex, Tata Motors Hospital, Kharangajhar, Jamshedpur 
Type of Sponsor  Private hospital/clinic 
 
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 Ashok Jadon  Tata Motors Hospital  Department of Anaesthesia and Pain Relief service, OT complex, Tata Motors Hospital, Kharangajhar, Jamshedpur
Purbi Singhbhum
JHARKHAND 		 9234554341

jadona@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee tata Motors Hospital, Jamshedpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  Selected patient will receive conventional analgesia and epidural as required. 
Intervention  Posterior transversus abdominis plane block  Selected patient will receive bilateral posterior TAP block with 0.375% ropivacaine after abdominal hysterectomy. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. ASA grade I-III
2. Total abdominal hysterectomy done via lower abdominal transverse (Pfannenstiel) incision.
 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. A history of drug allergy or local anaesthetic toxicity.
3. BMI >35kg/m2 (to limit maximum Ropivacaine dose to 3mg/kg)
4. Contraindications to regional anaesthesia (bleeding diathesis, infection at the site of block and peripheral neuropathy)
5. Change of anaesthetic technique to general anaesthesia.
6. Failure or complication in epidural catheter insertion.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Epidural morphine used   24hours 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of analgesia,
difference in Vas scores,
PONV, Sedation and Satisfaction 		 24 hours 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   N/A 
Date of First Enrollment (India)   29/05/2020 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Multimodal approach of analgesia (MMA) is the current standard practice to provide postoperative pain relief. TAP block has been used effectively as an adjunct to MMA. The results of various approaches of TAP block have given variable results and posterior TAP block is suppose to be more effective. However, more studies are required to prove its efficacy in various surgeries. We will evaluate the analgesic potential of posterior TAP block in abdominal hysterectomy. The primary outcome measure will be the amount of epidural morphine used in 24 hrs. The secondary out come measure would be the time for first request to analgesia, VAS scores and other side effects like PONV, sedation and respiratory depression. Assessment for patients satisfaction about analgesia will also be done. All the assessment will be done at 2,4,6,8,10,12 18 & 24 hrs. Sample size was calculated based on pilot study of morphine used and 64 patients (total) are required to get significant difference at 95% confidence level and 80% power for set p<0.05. Gpower software was used for sample size calculation. SPSS V22.0 will be used for statistical analysis. Depending upon the type of data, appropriate test will be used. 
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