| CTRI Number |
CTRI/2019/03/018299 [Registered on: 28/03/2019] Trial Registered Prospectively |
| Last Modified On: |
15/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing the use of isobaric ropivacaine with buprenorphinelevobupivacaine with Buprenorphine during spinal anaesthesia reduces post surgical pain relief medication |
|
Scientific Title of Study
|
Comparison of Isobaric Ropivacaine (0.75%) with Buprenorphine and Isobaric Levobupivacaine (0.5%) with Buprenorphine in patients undergoing surgeries under Subarachnoid block: A Prospective Randomized Double Blind Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aniruth Geethchand |
| Designation |
Post Graduate |
| Affiliation |
Department of Anaesthesiology, Chettinad Hospital and Research Institute, Kelambakkam, Chennai |
| Address |
053
Oorkad road,
Veeravanallur,
Tirneleveli
Department of Anaesthesiology and Critical Care
Chettinad Hospital and Research Institute,
Raghiv Gandhi salai,
Kelambakkam-603103
Chennai
TAMIL NADU
627426
India |
| Phone |
|
| Fax |
|
| Email |
aniruth2509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balamurugan B |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology, Chettinad Hospital and Research Institute, Kelambakkam, Chennai |
| Address |
Chettinad Hospital and Research Institute,
Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
|
| Fax |
|
| Email |
drbala.srmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aniruth Geethchand |
| Designation |
Post Graduate |
| Affiliation |
Department of Anaesthesiology, Chettinad Hospital and Research Institute, Kelambakkam, Chennai |
| Address |
053
Oorkad road,
Veeravanallur,
Tirunelveli
Chettinad Hospital And Research Institute
Raghiv Gandhi Salai
Kelambakkam,
Chennai-603103
Tirunelveli
TAMIL NADU
627426
India |
| Phone |
|
| Fax |
|
| Email |
aniruth2509@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital And Research Institute
Raghiv Gandhi Salai Kelambakkam,
Chennai-603103 |
|
|
Primary Sponsor
|
| Name |
Aniruth Geethchand |
| Address |
53, Oorkad Road,
Veeravanallur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aniruth Geethchand |
Chettinad Hospital And Research Institute |
Department of Anaesthesiology, Chettinad Hospital and Research Institute
Raghiv Gandhi Salai,
Kelambakkam,
Kanchipuram Dist-603103
Chennai
TAMIL NADU |
9443887214
aniruth2509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Academy of Research and Education |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Person coming for urological and lower limb surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Isobaric Ropivacaine (0.75%) with Buprenorphine and Isobaric Levobupivacaine (0.5%) with Buprenorphine |
Isobaric Ropivacaine (0.75%) with Buprenorphine
Isobaric Levobupivacaine (0.5%) with Buprenorphine
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 18 to 65 years.
2.American Society of Anesthesiologist (ASA) Grade I and II.
3.Lower abdominal surgeries
4.Lower limb orthopaedics surgeries
5.Both Elective and Emergency procedures
6.Duration of surgery ≥ 60 minutes
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing for regional anesthesia.
2. Patients not willing to be in the study group.
3. Pregnant patients.
4. Known allergy to the study drugs.
5. Patients with Peripheral neuropathy
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
compare the efficacy of Isobaric Ropivacaine(0.75%) with Buprenorphine 0.2 ml(60µg) and Isobaric Levobupivacaine (0.5%)with Buprenorphine 0.2ml(60µg) in patients undergoing surgeries under Subarachnoid block.
|
Onset of sensory block is defined as the time taken to achieve loss of temperature sensation at T8 dermatome using cold saline cotton swab. It will be assessed using Gromley and Hill 1996.
Onset of motor block is defined as the time taken to achieve complete motor block which is graded according to modified Bromage scale
Two segment regression of sensory block and motor regression time also be recorded.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare onset and duration of sensory blockade.
To compare onset and duration of motor blockade.
To assess and compare the hemodynamics between both groups.
To assess two segment sensory regression time.
Side effects if any.
|
Postoperative monitoring of pain will be assessed with visual analogue score (VAS) using a 10 cm line, where zero denotes no pain and 10 denotes worst possible pain. Pain score will be assessed post operatively every 30 minutes till the patient onset of pain.
If patient requiring rescue analgesia Injection Tramadol 50 mg slow iv will be given and the study will be terminated. Patient will be monitored for recovery of motor function to a Bromage score of 1 for every 30 mins.
|
|
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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
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/05/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of my study is to compare the efficacy of isobaric ropivacaine with buprenorphine and isobaric levobupivacaine with buprenorphine in patients who undergo surgeries under spinal anaesthesia in terms of Onset and duration of sensory blockade. Onset and duration of motor blockade. Hemodynamic stability between two groups. Drug having the least side effects. Drug that can be used for early ambulation. |