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CTRI Number  CTRI/2024/03/064415 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 14/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparison between the hyperbaric solutions of ropivacaine and levobupivacaine for spinal anaesthesia in lower limb orthopaedic surgeries 
Scientific Title of Study   A comparative study between 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in lower limb orthopaedic surgeries  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rudranka Basu 
Designation  Post Graduate Trainee 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care, Gauhati Medical College, Bhangagarh, Guwahati

Kamrup
ASSAM
781032
India 
Phone  9046001039  
Fax    
Email  rudra4022@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajib Hazarika 
Designation  Professor  
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care, Gauhati Medical College, Bhangagarh, Guwahati

Kamrup
ASSAM
781032
India 
Phone  9864063140  
Fax    
Email  Rajibhazarika8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajib Hazarika 
Designation  Professor  
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care, Gauhati Medical College, Bhangagarh, Guwahati

Kamrup
ASSAM
781032
India 
Phone  9864063140  
Fax    
Email  Rajibhazarika8@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical care, Gauhati Medical College and Hospital 
 
Primary Sponsor  
Name  Dr. Rudranka Basu 
Address  Department of Anaesthesiology and Critical Care, Gauhati Medical College, Guwahati, Assam PIN- 781006 
Type of Sponsor  Other [Self] 
 
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 Rudranka Basu  Gauhati Medical College and Hospital  Department of Anaesthesiology and Critical care
Kamrup
ASSAM 		 09046001039

rudra4022@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Gauhati Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: S721||Pertrochanteric fracture, (3) ICD-10 Condition: S722||Subtrochanteric fracture of femur, (4) ICD-10 Condition: S723||Fracture of shaft of femur, (5) ICD-10 Condition: S724||Fracture of lower end of femur, (6) ICD-10 Condition: S820||Fracture of patella, (7) ICD-10 Condition: S821||Fracture of upper end of tibia, (8) ICD-10 Condition: S822||Fracture of shaft of tibia, (9) ICD-10 Condition: S823||Fracture of lower end of tibia, (10) ICD-10 Condition: S824||Fracture of shaft of fibula, (11) ICD-10 Condition: S825||Fracture of medial malleolus, (12) ICD-10 Condition: S826||Fracture of lateral malleolus, (13) ICD-10 Condition: S832||Tear of meniscus, current injury, (14) ICD-10 Condition: M869||Osteomyelitis, unspecified, (15) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% hyperbaric Levobupivacaine  following lumbar puncture 3 ml (15 mg) of 0.5% hyperbaric Levobupivacaine will be injected intrathecally (in the sub-arachnoid space) for spinal anaesthesia and the patient will be monitored for duration of sensory and motor block and haemodynamic changes for the entire intra-operative period and in the post-operative period till the regression of analgesia. 
Intervention  0.75% hyperbaric Ropivacaine  following lumbar puncture 3 ml (22.5 mg) of 0.75% hyperbaric ropivacaine will be injected intrathecally (in the sub-arachnoid space) for spinal anaesthesia and the patient will be monitored for duration of sensory and motor block and haemodynamic changes for the entire intra-operative period and in the post-operative period till the regression of analgesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia.

2. Age 18-60 years

3. ASA 1 and 2

4. All genders

5. Patients posted for surgeries with expected duration less than 3 hours 
 
ExclusionCriteria 
Details  1. Patient refusal

2. History of allergic reactions to Local Anaesthetics

3. Coagulopathy

4. History of neurological disorders

5. Severe cardio, respiratory, hepatic and renal disease

6. Patients with spinal deformity

7. Patients with previous spinal surgery
 
 
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 
Aim- To compare the duration of analgesia between 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries

Objective-
1. To compare the onset of sensory block in two drugs.
2. To compare the onset of motor block in two drugs.
 		 Onset and time taken for regression of sensory and motor block will be recorded after every 3 minutes for the first 15 minutes after injection then every 5 minutes for the next 25 minutes and at 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes. Duration of analgesia was assessed using Numerical Rating Scale at 2, 4, 6 and 12 hours in the post-operative period. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the effect of the two drugs on hemodynamic parameters.
2. To evaluate any adverse effects. 		 Heart rate and Blood pressure will be monitored at every 5 minutes interval till 15 minutes followed by every 15 minutes interval till 90 minutes and then at every 30min interval. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

TITLE OF THESIS

A COMPARATIVE STUDY BETWEEN 0.75% HYPERBARIC ROPIVACAINE AND 0.5% HYPERBARIC LEVOBUPIVACAINE FOR SPINAL ANAESTHESIA IN LOWER LIMB ORTHOPAEDIC SURGERIES.

INTRODUCTION

New long-acting local anaesthetics, levobupivacaine and ropivacaine, both being pure left-isomers of bupivacaine and due to their three-dimensional structure seem to have lesser toxic effects on the central nervous system and the cardiovascular system. Through my study I intend to clinically compare the efficacy of 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine in spinal anaesthesia.

 

AIMS AND OBJECTIVES

AIM:

To compare the duration of analgesia between 0.5% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries.

OBJECTIVES:

PRIMARY:

A)      To compare the onset of sensory block in two drugs.

B)      To compare the onset of motor block in two drugs.

SECONDARY:

A)      To compare the effect of the two drugs on hemodynamic parameters.

B)      To evaluate any adverse effects.

 

MATERIALS AND METHODS AND DATA COLLECTION PROCEDURE

A total of 70 patients will be randomly divided into two groups of 35 patients each. Group A will receive 15 mg 0.5% (3 ml) hyperbaric levobupivacaine for spinal anaesthesia. Group B will receive 22.5 mg 0.75% (3 ml) hyperbaric ropivacaine for spinal anaesthesia. 

Onset and time taken for regression of sensory and motor block will be recorded after every 3 minutes for the first 15 min after injection then every five minutes for the next 25 min and at 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes. Duration of analgesia will be assessed using Numerical Rating Scale Score at 2, 4, 6 and 12 hours in the post-operative period. Heart rate and Blood Pressure will be monitored at 5 minutes interval for first 15 minutes followed by 15 minutes interval till 90 minutes and then at every 30 minutes interval. 

RESULTS AND ANALYSIS

The result will be statistically analyzed using appropriate statistical formula and will be presented using textual, tabular and graphical form.

CONCLUSION

After detailed discussion of the results and observation of the study, conclusion will be drawn in relation to above mentioned objectives of study.

REFERENCES

1.     H. Blomqvist and A. Nilsson, “Is Glucose-Free Bupiva-caine Isobaric or Hypobaric?” Regional Anesthesia and Pain Medicine, Vol. 14, No. 4, 1989, pp. 195-198.

2.     6 M. P. Vercauteren, H. C. Copp, V. L. Hoffmann, V. Sadien and H. A. Adriaensen, “Small-Dose Hyperbaric versus Plain Bupivacaine during Spinal Anesthesia for Cesarean Section,” Anesthesia & Analgesia, Vol. 86, No. 5, 1998, pp. 989-993.

3.      M. G. Richardson and R. N. Wissler, “Densities of Dextrose-Free Ä°ntrathecal Local Anesthetics, Opioids, and Combinations Measured at 37 Degrees C,” Anesthesia & Analgesia, Vol. 84, No. 1, 1997, pp. 95-99

4.      M. G. Richardson and R. N. Wissler, “Densities of Lumbar Cerebrospinal Fluid in Pregnant and Nonpregnant Humans,” Anesthesiology, Vol. 85, No. 2, 1996, pp. 326-330 3. M. G. Richardson and R. N. Wissler, “Densities of Lumbar Cerebrospinal Fluid in Pregnant and Nonpregnant Humans,” Anesthesiology, Vol. 85, No. 2, 1996, pp. 326-330

5.     Stefania Leone, Simone Di Cianni, Andrea Casati†, Guido Fanelli Department of Anesthesia and Pain Therapy, University Hospital of Parma, Parma (Italy), “Pharmacology, toxicology, and clinical use of new long acting local anesthetics, ropivacaine and levobupivacaine”

6.     Chung, Chan-Jong MD; Choi, So-Ron MD; Yeo, Kwang-Hwan MD; Park, Han-Suk MD; Lee, Soo-Il MD; Chin, Young-Jhoon MD, “Hyperbaric Spinal Ropivacaine for Cesarean Delivery: A Comparison to Hyperbaric Bupivacaine”

7.     Anjani Kumar Singh1, Selvakumar Palaniappan2, K. Selvaraju, “To Evaluate Efficacy and Safety of Isobaric Levobupivacaine Versus Hyperbaric Bupivacaine in Lower Limb Orthopaedic Surgeries”

8.     Gianluca Cappelleri, MD*, Giorgio Aldegheri, MD*, Giorgio Danelli, MD†, Chiara Marchetti, MD*, Massimiliano Nuzzi, MD†, Gabriella Iannandrea, MD†, and Andrea Casati, MD† *Department of Anesthesiology, Vita-Salute University of Milan, IRCCS H. San Raffaele, Milan, Italy; †Department of Anesthesiology, University of Parma, Azienda Ospedaliera di Parma, Parma, Italy, “Spinal Anesthesia with Hyperbaric Levobupivacaine and Ropivacaine for Outpatient Knee Arthroscopy: A Prospective, Randomized, Double-Blind Study”


 
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