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CTRI Number  CTRI/2026/03/106006 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
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 comparative study which aims to compare two differently acting anaesthetic drugs in how they effect the respiratory diaphragm function when used as anaesthetic blocks for forearm surgeries - a randomised control trail 
Scientific Title of Study   Comparison of Levobupivacaine and Ropivacaine on Diaphragmatic function in patients undergoing Forearm surgeries under ultrasound guided Supraclavicular Brachial Plexus Block - a randomised control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vemulapalli Meghana 
Designation  Junior Resident  
Affiliation  Nizam’s Institute of Medical Sciences  
Address  Department of Anaesthesiology, Old building, Nizam’s Institute of Medical Sciences, Panjagutta, Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9618749512  
Fax    
Email  vemulapallimeghana9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. K. Geeta 
Designation  Professor  
Affiliation  Nizam’s Institute of Medical Sciences  
Address  Department of Anaesthesiology, Old building, Nizam’s Institute of Medical Sciences, Panjagutta, Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9849264451  
Fax    
Email  drgeeta3007@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Vemulapalli Meghana 
Designation  Junior Resident  
Affiliation  Nizam’s Institute of Medical Sciences  
Address  Department of Anaesthesiology, Old building, Nizam’s Institute of Medical Sciences, Panjagutta, Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9618749512  
Fax    
Email  vemulapallimeghana9@gmail.com  
 
Source of Monetary or Material Support  
Nizam’s Institute of Medical Sciences, Panjagutta, Hyderabad - 500082, Telangana, India 
 
Primary Sponsor  
Name  Vemulapalli Meghana 
Address  Nizam’s Institute of Medical Sciences, Panjagutta, Hyderabad- 500082, Telangana  
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 Vemulapalli Meghana   Nizam’s Institute of Medical Sciences   Department of Anaesthesiology, Old building, Panjagutta, Hyderabad- 500082, Telangana
Hyderabad
TELANGANA 		 9618749512

vemulapallimeghana9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levobupivacaine administration   0.375% Levobupivacaine that is 15 mL of 0.5% Levobupivacaine inn+ 5ml of NS is administered  
Comparator Agent  Ropivacaine   0.375% Ropivacaine that is 10ml of 0.75% of Ropivacaine + 10 mL of NS is administered  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  1) ASA Grade 1 and 2
2) Forearm Surgeries  
 
ExclusionCriteria 
Details  1) Patient refusal
2) Local infection
3) Bleeding disorders
4) Coagulopathies
5) Allergic to local anesthetic agent
6) Patients with neuromuscular disorders and weakness and hemidiaphragmatic dysfunction
7) Patients with pre-existing cardiac and lung pathologies
8) Pregnancy  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The patients receiving Ropivacaine have less incidence of diaphragmatic dysfunction as compared to Levobupivacaine   Assessment will be done at baseline, 15 minutes, 30 minutes and 2 hours after the block 
 
Secondary Outcome  
Outcome  TimePoints 
Onset of sensory blockade  Assessment done at regular intervals of one minute to determine time of onset of block 
Onset of motor blockade   Assessment done at regular intervals of one minute to determine time of onset of block 
Duration of analgesia   Assessment done at intervals of immediate post op, at 6 hours, 12 hours, 24 hours & 48 hours post op points 
 
Target Sample Size   Total Sample Size="182"
Sample Size from India="182" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/04/2026 
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 Yet Recruiting 
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  

Ropivacaine and Levobupivacaine are two commonly used local anaesthetics in supraclavicular block for forearm surgeries. Various complications can occur with supraclavicular block like hemidiaphragmatic paralysis (HDP) which is usually asymptomatic in healthy individuals but severe complications exists in patients with respiratory compromise. Various other complications can also be associated with supraclaviclavicular block.

The study compares the incidence of HDP in patients who will be given Levobupivacaine vs ropivacaine under ultrasound guidance supraclavicular brachial plexus block in forearm surgeries.

A total sample size of 182 patients will be selected based upon the inclusion and exclusion criteria and will be randomly divided into 2 groups with each group consisting of 91 patients.

Baseline assessment will be done followed by post block assessment for diaphragmatic paralysis at 15 mins, 30 mins and 2 hours and patients shall be assessed whether they are asymptomatic or symptomatic.

NRS score of the patients will be taken post operatively at 6 hours, 12 hours and 24 hours to assess for pain. Rescue analgesia shall be provided to the patient as needed.

 
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