| 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 |
|
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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 |
|
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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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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)?
|
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Brief Summary
|
A COMPARATIVE STUDY OF 0.5 % BUPIVACAINE WITH FENTANYL VERSUS
0.75% ROPIVACAINE WITH FENTANYL IN EPIDURAL ANAESTHESIA FOR
ABDOMINAL HYSTERECTOMY
Objectives:
-
To compare the onset of motor and sensory block.
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To find out the duration of the sensory and motor blockade.
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To observe intraoperative hemodynamic changes and assess post-operative analgesia
requirements in 24 hour.
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To find out the duration of analgesia assessed by requirement of first rescue analgesic.
-
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:
-
Onset of sensory block ( time from epidural injection to the occurrence of sensory block at
dermatome level T6)
-
Duration of sensory block (time for two segment regression).
-
Onset of motor block (time from completion of epidural injection to the time when
Bromage grade 0 changed to grade 1)
-
Duration of motor block was assessed every 30min using Modified Bromage scale and
RAM (rectus abdominis muscle) test.76
-
Duration of analgesia (time for rescue analgesia)
-
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
-
0 Paralyzed, unable to evaluate
-
1 Awake
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2 Lightly Sedated
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3 Moderately sedated, follows simple commands
-
4 Deeply sedated, responds to non-painful stimuli
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5 Deeply sedated, responds only to painful stimuli
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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.
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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