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CTRI Number  CTRI/2018/05/014149 [Registered on: 25/05/2018] Trial Registered Retrospectively
Last Modified On: 24/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study for effectiveness of local anaesthetic drugs in abdominal hysterectomy surgery 
Scientific Title of Study   A comparative study of 0.5% bupivacaine with fentanyl versus 0.75% ropivacaine with fentanyl in epidural anesthesia for abdominal hysterectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR OINDRILA SINHA 
Designation  Junior Resident Anesthesia 
Affiliation  IPGMER, Kolkata 
Address  Department of Anethesiology, Institute of Postgraduate Medical Education and Research 244B Acharya J. C. Bose Road Kolkata
Department of Anethesiology, Institute of Postgraduate Medical Education and Research 244B Acharya J. C. Bose Road Kolkata 700020
Kolkata
WEST BENGAL
700020
India 
Phone  7044315280  
Fax    
Email  droindri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SANKARI SANTRA 
Designation  Head & Professor 
Affiliation  IPGMER, Kolkata 
Address  Department of Anethesiology, Institute of Postgraduate Medical Education and Research 244B Acharya J. C. Bose Road Kolkata
Department of Anethesiology, Institute of Postgraduate Medical Education and Research 244B Acharya J. C. Bose Road Kolkata 700020
Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  sankarisantra@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR OINDRILA SINHA 
Designation  Junior Resident Anesthesia 
Affiliation  IPGMER, Kolkata 
Address  Department of Anethesiology, Institute of Postgraduate Medical Education and Research 244B Acharya J. C. Bose Road Kolkata
Department of Anethesiology, Institute of Postgraduate Medical Education and Research 244B Acharya J. C. Bose Road Kolkata 700020
Kolkata
WEST BENGAL
700020
India 
Phone  7044315280  
Fax    
Email  droindri@gmail.com  
 
Source of Monetary or Material Support  
Institute of Postgraduate Medical Education Research 244B A J C Bose Road Dept of Anesthesiology Kolkata 700020 
 
Primary Sponsor  
Name  Institute of Postgraduate Medical Education Research 
Address  Institute of Postgraduate Medical Education Research 244B A J C Bose Road Dept of Anesthesiology, Kolkata 700020 
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 OINDRILA SINHA  Gynecology operation theatre of Institute of Postgraduate Medical Education and Research  244B Acharya J. C. Bose Road Kolkata 700020 Division: Gynecology operation theatre and Department of Anesthesiology, Kolkata WEST BENGAL
Kolkata
WEST BENGAL 
7044315280

droindri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Postgraduate Medical Education and Research 244B Acharya J. C. Bose Road Kolkata 700020  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Awaited for abdominal hysterectomy operation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bupivacaine with Fentanyl (Local anaesthetic and opioid)  A single dose 0.5% Bupivacaine with 100microgram Fentanyl drugs by route of administration epidural injection Total duration for end of surgery ( hysterectomy) 
Comparator Agent  Ropivacaine with Fentanyl (Local anaesthetic and opioid)  A single dose 0.75% Ropivacaine with 100microgram Fentanyl drugs and administered through route as epidural injection. Total duration: till end of surgery(hysterectomy) 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Adult female patients, aged between 30 to 65 yrs
2. BMI 18.5 to 29.9 kg/meter2
3. ASA physical status I & II.
4. Patients scheduled for elective abdominal hysterectomy under lumbar epidural anaesthesia. 
 
ExclusionCriteria 
Details  a) Patient refusal.
b) Any contraindication to epidural anaesthesia –
i. Infection at the site of injection
ii. Coagulopathy
iii. Neurological disorders and psychiatric disorder
iv. Haemodynamically compromised patients
v. Sepsis
vi. Gross anatomical abnormality of vertebral column.
vii. Known allergy to either bupivacaine or ropivacaine or fentanyl.
viii. Patients on chronic antiplatelet drugs and anticoagulants. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To conclude that in the present study using 0.5% bupivacaine with fentanyl and 0.75% ropivacaine with fentanyl epidurally, ropivacaine produced an earlier onset but similar duration of sensory block. The onset, quality and duration of motor block were comparable in both the groups.  During hysterectomy operation for two hours 
 
Secondary Outcome  
Outcome  TimePoints 
In hemodynamics, heart rate was comparable in both groups but blood pressures (SBP, MAP, DBP) was decrease significantly in bupivacaine group after 20min of administration of the epidural study drug.  Post operative assessment for 24hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   09/03/2016 
Date of Study Completion (India) 21/06/2017 
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   Applied for  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A COMPARATIVE STUDY OF 0.5 % BUPIVACAINE WITH FENTANYL VERSUS 0.75% ROPIVACAINE WITH FENTANYL IN EPIDURAL ANAESTHESIA FOR ABDOMINAL HYSTERECTOMY 

Objectives:
  1. To compare the onset of motor and sensory block.

  2. To find out the duration of the sensory and motor blockade.

  3. To observe intraoperative hemodynamic changes and assess post-operative analgesia

    requirements in 24 hour.

  4. To find out the duration of analgesia assessed by requirement of first rescue analgesic.

  5. To observe any untoward incident during intraoperative and post-operative period and managed accordingly 


Methods:

All sensory and motor assessments were made at 0,2,4,6,8,10,12,15,20,25 and 30 min and then every 15 min until the block was regressed completely unless sedation, anesthesia, or surgery prevented assessment. A single observer performed all assessments.
Assessments of parameters include:

  1. Onset of sensory block ( time from epidural injection to the occurrence of sensory block at dermatome level T6)

  2. Duration of sensory block (time for two segment regression).

  3. Onset of motor block (time from completion of epidural injection to the time when

    Bromage grade 0 changed to grade 1)

  4. Duration of motor block was assessed every 30min using Modified Bromage scale and

    RAM (rectus abdominis muscle) test.76

  5. Duration of analgesia (time for rescue analgesia)

  6. Hemodynamic changes - heart rate, blood pressure, respiratory rate and pulse oximetry

    saturation on every 5 minutes for first 30 minutes and thereafter measurement has been taken for every 10 minutes till the end of surgery.

7. Obvious side effects – nausea and vomiting, hypotension, pruritus, retention of urine, respiratory depression.
Sedation by fentanyl was assessed by modified Ramsay sedation score.

Modified Ramsay sedation score:

Score Clinical response

  1. 0  Paralyzed, unable to evaluate

  2. 1  Awake

  3. 2  Lightly Sedated

  4. 3  Moderately sedated, follows simple commands

  5. 4  Deeply sedated, responds to non-painful stimuli

  6. 5  Deeply sedated, responds only to painful stimuli

  7. 6  Deeply sedated, unresponsive to painful stimuli

    All patients received balanced salt solution.

    Bradycardia, defined as heart rate (HR) <50/min, was managed by Inj. Atropine 0.6mg IV

bolus (may require repeatation). It was aimed to maintain the MAP between 65 and 85 mm Hg. Hypotension, defined by decrease in mean arterial blood pressure more than 20% below baseline or in normotensive patients, fall in systolic pressure below 90 mm Hg was treated with IV crystalloid fluid bolus and subsequently IV phrenylephrine and IV mephentermine bolus (titrated to patient response) as necessary. Persistent hypotension was treated with a bolus of 100-200ml crystalloids and maximally infused three boluses per hour according to clinical situation.

Analgesia was assessed by VAS pain score which is a linear pain scoring tool ranging from 0 to 100 mm where 0 means no pain and 100 means worst possible pain.

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Rescue analgesia was administered postoperatively in the form of 8ml of either 0.125% solution of racemic bupivacaine or 0.2% ropivacaine respectively in group B and group R when VAS score > 40 or patient requested for analgesia.

Timing of first rescue analgesia and total analgesic doses within first 24 hours were noted. Analgesia was assessed by a trained research assistant with the visual analogue pain score (VAS), at rest and at coughing. Post-operatively VAS was noted two hourly till 24 hour of surgery. Top-up rescue drug (epidural local anesthetic) was given if patients complained of pain or when

VAS score was >40. 

 
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