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CTRI Number  CTRI/2018/04/013312 [Registered on: 17/04/2018] Trial Registered Retrospectively
Last Modified On: 14/04/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparing a nerve block given into a plane(transversus abdominis plane) on the anterior abdominal wall using ultrasound before putting surgical incision and after putting surgical incision 
Scientific Title of Study   COMPARATIVE STUDY BETWEEN THE EFFECTS OF PRE VERSUS POST INCISIONAL TRANSVERSUS ABDOMINIS PLANE BLOCK ON ACUTE POST ABDOMINAL HYSTERECTOMY PAIN 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Emy Ambooken 
Designation  Senior Resident 
Affiliation  Amala Institue Of Medical Sciences,Amala Nagar,Thrissur 
Address  Department O f Anaesthesiology Amala Institute Of Medical Sciences Amala Nagar Thrissur

Thrissur
KERALA
680555
India 
Phone  9809750033  
Fax    
Email  emyambooken@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Joe John Chirayath 
Designation  Associate Professor 
Affiliation  Amala Institue Of Medical Sciences 
Address  Department Of Anaesthesiology Amala Institute Of Medical Sciences Amala Nagar Thrissur

Thrissur
KERALA
680555
India 
Phone  9526454443  
Fax    
Email  joechirayath@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Joe John Chirayath 
Designation  Associate Professor 
Affiliation  Amala Institue Of Medical Sciences 
Address  Department Of Anaesthesiology Amala Institute Of Medical Sciences Amala Nagar Thrissur

Kollam
KERALA
680555
India 
Phone  9526454443  
Fax    
Email  joechirayath@yahoo.co.in  
 
Source of Monetary or Material Support  
Amala Institute Of Merdical Sciences 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Amala Institute Of Medical Sciences Amala Nagar Thrissur Kerala 
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 
Dr Emy Ambooken  Amala Institute Of Medical Sciences.  Department Of Anaesthesiology Amala Institute Of Medical Sciences Amalanagar
Thrissur
KERALA 		 9809750033

emyambooken@gmail.com 
 
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  Those patients posted for total abdominal hysterectomy belonging to ASA 1 or 2 in the department of anaesthesiology at Amala Institute Of Medical Sciences,Thrissur,kerala,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COMPARATIVE STUDY BETWEEN THE EFFECTS OF PRE VERSUS POST INCISIONAL TRANSVERSUS ABDOMINIS PLANE BLOCK ON ACUTE POST ABDOMINAL HYSTERECTOMY PAIN   Study comprises 54 patients who underwent a total abdominal hysterectomy under spinal anaesthesia. Alternate patients satisfying the inclusion criteria were either given a pre-incisional or post incisional transversus abdominis plane block with 20 ml of 0.25% bupivacaine bilaterally. Postoperatively, the Visual Analogue Scale (VAS) for pain was observed. We also looked for nausea, vomiting, and sedation scores. These were noted at the time of arrival to the recovery room, and thereafter at 0.5, 1, 2, 4, 6, 12 and 24 hours (after the surgery). 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  a)Patients scheduled for total abdominal hysterectomy with or without oophorectomy using Pfannensteil incision.

b)Patients belonging to ASA I and II.

c)Age 30-60 years.
 
 
ExclusionCriteria 
Details  a)Patient refusal for the procedure

b)History of relevant drug allergy, coagulopathy or opioid dependence.

c)TAP block using drugs other than bupivacaine.

d)Patients in whom spinal anaesthesia is contra indicated.

e)Failed spinal anaesthesia.

f)Patients with BMI ≥ 30.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare between the effects of pre versus post incisional transversus abdominis plane block on acute post-abdominal hysterectomy pain. The primary outcome measures included VAS scores, post-operative opioid consumption in the first 24 hours and any complications of TAP block.  First 24 hours following surgery 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome measures included PONV, sedation and the need for rescue antiemetics.  First 24 hours following surgery 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/01/2015 
Date of Study Completion (India) 26/05/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No publication 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Transversus abdominis plane block is an effective block for post operative pain relief in lower abdominal surgeries like total abdominal hysterectomy and is more effective when performed under ultrasound guidance.It is said that blocks performed before surgical incision is more effective as compared to blocks performed after completion of surgery.Hence present study was undertaken to compare the efficacy of ultrasound guided transversus abdominis plane block performed before surgical incision with that performed after surgery.Here 54 patients coming under inclusion criteria were alternatively allocated to receive either pre-incisional or post-incisional TAp block.Each patients received 20 ml of 0.5% Bupivacaine for block bilaterally under ultrasound.Post operatively they where assessed for pain ,requirement for rescue analgesia with morphine and their opioid dependent side effects like nausea vomiting,sedation score, respiratory depression and other complications of block.A statistically significant decrease in post operative pain was noticed from 2nd post-operative hour onward till 12 hours and thereafter it was comparable between both the groups.The total morphine required in the first 24-hour post-operative period was significantly less in the pre-incisional TAP block group (36mg) compared to the other group (123 mg). Also,the mean time to first request for morphine was significantly longer in patients belonging to the pre-incisional TAP block group (pre incisional group 10.8 hours vs post incisional group 3.64 hours with a p value of 0.002).There was no significant difference in sedation scores post-operatively,except at 4th hour,where it was significantly higher(0.024) in the post-incisional group.Post operative nausea and vomiting was also significanlty higher and the dose of anti-emetic used was also more in the post-incisional TAP block group. 
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