| CTRI Number |
CTRI/2022/01/039595 [Registered on: 20/01/2022] Trial Registered Retrospectively |
| Last Modified On: |
20/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare spinal Bupivacaine and Ropivacaine, each with fentanyl in lower limb surgeries in adults
|
|
Scientific Title of Study
|
A randomized controlled study of intrathecal
bupivacaine with fentanyl and ropivacaine with
fentanyl in lower limb surgeries in adults
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LHMC/ECHR/2014/49 |
Protocol Number |
| U1111-1182-7674 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARJUN NAIR |
| Designation |
MBBS, MD(ANAESTHESIOLOGY) |
| Affiliation |
LADY HARDINGE MEDICAL COLLEGE |
| Address |
Lady Hardinge medical college,
Connaught Place,
New Delhi Connaught place, New Delhi, Delhi Central DELHI 110001 India |
| Phone |
9891420887 |
| Fax |
|
| Email |
nairarjun06@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
MAITREE PANDEY |
| Designation |
PROFESSOR ANAESTHESIOLOGY |
| Affiliation |
LADY HARDINGE MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
LADY HARDINGE MEDICAL COLLEGE AND SUCHETA KRIPLANI HOSPITAL,
CONNAUGHT PLACE
Central DELHI 110001 India |
| Phone |
9810570515 |
| Fax |
|
| Email |
maitreepandey@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
ARJUN NAIR |
| Designation |
MBBS, MD(ANAESTHESIOLOGY) |
| Affiliation |
LADY HARDINGE MEDICAL COLLEGE |
| Address |
Lady Hardinge medical college,
Connaught Place,
New Delhi Lady Hardinge medical college,
Connaught Place,
New Delhi West DELHI 110001 India |
| Phone |
9891420887 |
| Fax |
|
| Email |
nairarjun06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge medical college and Sucheta Kriplani hospital
Connaught Place, Delhi - 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge medical college |
| Address |
Connaught Place,
New Delhi 110001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DR ARJUN NAIR |
Lady Hardinge medical college and Sucheta Kriplani hospital |
Department of Anaesthesiology
New Delhi DELHI |
9891420887
nairarjun06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, patients with orthopedic lower limb surgical intervention free from other systemic diseases were chosen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUPIVACAINE HYROCHLORIDE |
BUPIVACAINE 0.5% , 10 mg used once intrathecally, a long acting local anaesthetic approved for intrathecal use , duration of action approximately 240 minutes |
| Intervention |
ROPIVACAINE HYDROCHLORIDE |
ROPIVACAINE 0.75% ,15 mg used once intrathecally, long acting local anaesthetic approved for intrathecal use, duration of action approximately 90 - 120 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA grade I and II
2) Patients scheduled for lower limb surgeries
|
|
| ExclusionCriteria |
| Details |
1) Patients with ASA grade III and IV
2) History of known hypersensitivity to any drugs being used
3) Mental disturbances
4) Contraindications to neuraxial blockade
5) BMI ≥ 40 kg/m2
6) Surgery lasting for > 2hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Duration of sensory block assessed by regression of the sensory level to T-10 dermatome (by Hollmen scale )
2) Duration of motor block assessed by time to achieve the Bromage- 0 (in minutes by modified Bromage scale)
|
Every 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Heart rate and mean blood pressure will be measured every 30 minutes for first 2 hours and then 1 hourly.
2) Side effects- headache, nausea, vomiting, numbness, pain, weakness.
3) A VAS score of more than or equal to 4 would be marked as end of effective analgesia & patient will be administered rescue analgesia.
|
Heart rate and mean blood pressure will be measured every 30 minutes for first 2 hours and then 1 hourly. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/11/2013 |
| Date of Study Completion (India) |
31/03/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Kallio H, Snäll E-VT, Tuomas CA, Rosenberg PH. Comparison of hyperbaric and plain ropivacaine 15 mg in spinal anaesthesia for lower limb surgery. Br J Anaesth. 2004 Nov;93(5):664–9.
Chung CJ, Choi SR, Yeo KH, Park HS, Lee SI, Chin YJ. Hyperbaric spinal ropivacaine for cesarean delivery: a comparison to hyperbaric bupivacaine. Anesth Analg. 2001 Jul;93(1):157–61. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bupivacaine was the first long acting amino amide local anaesthetic used. Ropivacaine is a relatively newer long acting local anaesthetic belonging to the amino amide group. Both have similar structure, pharmacology, mechanism of action and physicochemical property but ropivacaine has an added advantage with lesser cardio toxicity and neurotoxicity. This drug has been introduced in the Indian market only recently and there is a paucity of studies in India which compare it with routinely used hyperbaric bupivacaine intrathecally for orthopedic lower limb surgeries. Therefore this study was to evaluate the clinical efficacy of 0.75% isobaric ropivacaine with fentanyl compared to 0.5% hyperbaric bupivacaine with fentanyl administered inrathecally for orthopedic lower limb surgeries. 80 patients, ASA grade I and II, aged 20-65 yrs scheduled for orthopedic procedures were included in this study. After careful pre-anaesthetic check up and routine investigations, an informed consent was taken from the patients. Patients were kept fasting overnight after a light meal. Premedication with tablet rantidine 150 mg per orally at night and in the morning, 2 hours before the surgery was given to all the patients. · After shifting the patients to the operating table, ECG, SpO2, NIBP monitor were attached and baseline values of heart rate (HR), blood pressure (BP) were noted. The patients were preloaded with 10 - 12 ml/kg of Ringer’s lactate over 15-20 minutes after securing 18G intravenous canula in non dominant forearm. Before commencement of anaesthesia patients were instructed on method of sensory and motor assessment. Combined spinal epidural anaesthesia was performed at L3/L4 or L4/L5 intervertebral space using 18G tuohy’s needle for epidural space and 27G Whittacre’s needle for subarachnoid block via needle through needle technique. After confirming free flow c.s.f, study drug was given slowly over 30 seconds. Immediately after intrathecal injection the spinal needle will be withdrawn, epidural catheter will be put through the Tuohy’s needle and the patient will be made to lie supine on the operating table. Surgery will be allowed after level of block reaches T 10 dermatome. An anaesthesiologist who was blinded regarding which local anaesthetic used assessed the sensory and motor block. GROUP R (n=40): 2.5 ml of 0.75% ropivacaine (isobaric) with 25 µg fentanyl (0.5 ml) GROUP B (n=40): 2.5 ml of 0.5% bupivacaine (hyperbaric) with 25 µg fentanyl (0.5 ml) Intra-operatively, heart rate, non invasive blood pressure, continuous ECG, spO2 monitoring, quality of surgical anaesthesia, onset and duration of sensory and motor block, and any other side effects were observed by another researcher who was blinded to the drug given. Post operatively, heart rate, non invasive blood pressure, regression of sensory and motor block, duration of post operative analgesia and any other side effects were observed. Patients in both the groups were comparable with regard to age, weight, height and type of surgery. HYPOTHESIS We hypothesize that addition of intrathecal ropivacaine with fentanyl would be equally effective as compared to that of intrathecal bupivacaine with fentanyl for duration of sensory and motor blockade and hemodynamic response. |