| CTRI Number |
CTRI/2022/08/044871 [Registered on: 24/08/2022] Trial Registered Prospectively |
| Last Modified On: |
23/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Efficacy of Bupivacaine vs Ropivacaine for nerve blocks in upper limb surgeries |
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Scientific Title of Study
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A comparative study between 0.5% Bupivacaine and 0.75% Ropivacaine in ultrasound guided nerve block for patients undergoing upper limb surgeries, a prospective interventional randomized control study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Phani Vijay |
| Designation |
Post graduate student |
| Affiliation |
Medicover Hospitals, Hitech City, Hyderabad |
| Address |
Department of Anaesthesiology, 4th floor,
Medicover Hospitals,
Ibis Hotel Lane,
HUDA Techno Enclave,
Hitech city
Hyderabad
TELANGANA
500081
India |
| Phone |
09585115242 |
| Fax |
|
| Email |
vijjunmaddy@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Anantha Sai Tej Narayanam |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Medicover Hospitals, Hitech City, Hyderabad |
| Address |
Department of Anaesthesiology,
4th floor,
Medicover Hospitals,
Ibis Hotel Lane,
HUDA Techno Enclave,
Hitech city
Hyderabad
TELANGANA
500081
India |
| Phone |
09585115242 |
| Fax |
|
| Email |
Tejab4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Phani Vijay |
| Designation |
Post graduate student |
| Affiliation |
Medicover Hospitals, Hitech City, Hyderabad |
| Address |
Department of Anaesthesiology,
4th floor,
Medicover Hospitals,
Ibis Hotel Lane,
HUDA Techno Enclave,
Hitech city
Hyderabad
TELANGANA
500081
India |
| Phone |
09585115242 |
| Fax |
|
| Email |
vijjunmaddy@gmail.com |
|
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Source of Monetary or Material Support
|
| This trial is not receiving any external funding. The study is being conducted at Medicover Hospital, Hitech City, Hyderabad |
|
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Primary Sponsor
|
| Name |
Dr Phani Vijay |
| Address |
Department of Anaesthesia, Medicover Hospitals, Hitech City, Hyderabad |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Medicover Hospitals |
Ibis Hotel Lane, HUDA techno enclave, Hitech city, Hyderabad- 500081 |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Phani Vijay |
Medicover Hospitals, Hitech City |
Department of Anaesthesiology,
4th floor, Medicover Hospitals,
Ibis Hotel Lane, Huda techno enclave, Hitech City, Hyderabad- 500081
Hyderabad
TELANGANA |
9666086274
vijjunmaddy@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Medicover (formerly Maxcure) Hospitals |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided brachial plexus block anaesthesia using 20ml of 0.5% bupivacaine (along with 20ml of 2% lignocaine with adrenaline) as the anaesthetic agent |
Interscalene, axillary or supraclavicular approach for ultrasound guided, single-shot brachial plexus block shall be used, to compare the efficacy of bupivacaine vs ropivacaine in patients undergoing elective upper limb surgery. The effects of the anaesthetic agent following the single shot of block anaesthesia shall be evaluated for a total duration of six hours following administration of anaesthesia in each patient, for the duration of the study. |
| Comparator Agent |
Ultrasound guided brachial plexus block anaesthesia using 20ml of 0.75% ropivacaine (along with 20ml of 2% lignocaine with adrenaline) as the anaesthetic agent |
Interscalene, axillary or supraclavicular approach for ultrasound guided, single-shot brachial plexus block shall be used, to compare the efficacy of bupivacaine vs ropivacaine in patients undergoing elective upper limb surgery. The effects of the anaesthetic agent following the single shot of block anaesthesia shall be evaluated for a total duration of six hours following administration of anaesthesia in each patient, for the duration of the study. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 physical status
Scheduled for elective surgery under brachial plexus block
No h/o allergy or sensitivity to any of the studied local anaesthetics
Patients weighing over 50kg |
|
| ExclusionCriteria |
| Details |
Patients with :
Bleeding disorders
Neuromuscular disorders
Cardiovascular compromise
COPD
Hepatic dysfunction
Renal failure
Patient refusal to participate |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Double Blind Double Dummy |
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Primary Outcome
|
| Outcome |
TimePoints |
| Time duration of analgesia following administration of block shall be assessed in terms of: time after administration of the single shot brachial plexus block- till the time when the patient complains of pain. |
After administration of anaesthetic agent,
the patient shall undergo surgery. The presence or absence of pain at the surgical site shall be noted every hour following administration of block- till 6 hours following the block, or till the patient complains of pain- whichever occurs earlier. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Onset of sensory blockade |
after administration of anaesthesia |
| onset of motor blockade |
after administration of anaesthesia |
| Onset of sensory recovery |
after administration of anaesthesia |
| Onset of motor recovery |
after administration of anaesthesia |
| Peak of sensory block |
after administration of anaesthesia |
| Peak of motor block |
after administration of anaesthesia |
| Visual analog score at 6 hours |
6 hours after administration of anaesthesia |
| Need for rescue analgesia |
after administration of anaesthesia |
| Hemodynamic stability |
after administration of anaesthesia |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
29/08/2022 |
| 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="0"
Months="0"
Days="15" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
INTRODUCTION:
Bupivacaine is an amide local anaesthetic frequently used for brachial plexus nerve block as it offers the advantage of providing a long duration of action and a favourable ratio of sensory to motor neural block . Bupivacaine binds to the intracellular portion of sodium channels and blocks sodium influx into nerve cells, which prevents depolarization. Bupivacaine is metabolized primarily in the liver via conjugation with glucuronic acid.
Ropivacaine is a long-acting amide local anaesthetic with a potentially improved safety profile when compared to bupivacaine . Ropivacaine is less lipophilic than bupivacaine and is less likely to penetrate large myelinated motor fibres, resulting in a relatively reduced motor blockade. Ropivacaine has a greater degree of motor sensory differentiation. It has selective action on the pain-transmitting A Delta and C nerves rather than Aβ fibres, which are involved in motor function.
AIMS AND OBJECTIVES OF THE STUDY:
To compare the efficacy of 20 ml 0.5 % bupivacaine and 20 ml 2 % lignocaine with adrenaline vs 20 ml 0.75% Ropivacaine and 20 ml 2 % lignocaine with adrenaline. 1. To compare the efficacy in duration of analgesia 2. To compare the onset of sensory and motor blockade and any side effects. 3. To compare the hemodynamic instability
MATERIALS AND METHODS: 60 patients aged between 18-60 years with comparable demographic variables, undergoing upper extremity surgery under brachial plexus block at MEDICOVER HOSPITAL,HITECH CITY, HYDERABAD shall be randomly allocated to two groups of 30 each. Data shall be collected regarding the efficacy of each modality of anaesthesia, tabulated, and statistically analyzed to assess if one form of anaesthesia is superior to the other.
Administration of block: Supraclavicular, axillarly or interscalene approach shall be used Ultrasound guidance shall be used.
Data pertaining to efficacy of each anaesthetic agent shall be documented, and analyzed statistically to assess efficacy in various parameters including: Onset of sensory blockade Onset of motor blockade Onset of sensory recovery Onset of motor recovery Onset of peak sensory block Duration of analgesia Need for rescue analgesia Hemodynamic stability.
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