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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  
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 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  
Status 
Not Applicable 
 
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.

 
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