| CTRI Number |
CTRI/2021/01/030277 [Registered on: 06/01/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISION OF ADDITION OF FENTANYL V/S NEOSTIGMINE TO BUPIVACAINE IN UPPER LIMB SURGERIES FOR DURATION OF ANALGESIA |
|
Scientific Title of Study
|
A Comparative Efficacy of Addition of Fentanyl v/s Neostigmine to
Isobaric 0.25% Bupivacaine in USG Guided Supraclavicular Brachial
Plexus Block in Upper Limb 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 PRAGYA SHUKLA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
TRAUMA CENTER, IMS BHU |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
TRAUMA CENTER
IMS, BHU
VARANASI
TRAUMA CENTER,
IMS, BHU
VARANASI
Varanasi
UTTAR PRADESH
221106
India |
| Phone |
9637233147 |
| Fax |
|
| Email |
shukla.pragya0509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRAGYA SHUKLA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
TRAUMA CENTER, IMS BHU |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
TRAUMA CENTER,
IMS BHU
VARANASI
TRAUMA CENTER, IMS BHU
VARANASI
Varanasi
UTTAR PRADESH
221106
India |
| Phone |
9637233147 |
| Fax |
|
| Email |
shukla.pragya0509@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRAGYA SHUKLA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
TRAUMA CENTER, IMS BHU |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
TRAUMA CENTER,
IMS BHU
VARANASI
TRAUMA CENTER, IMS BHU
VARANASI
Varanasi
UTTAR PRADESH
221106
India |
| Phone |
9637233147 |
| Fax |
|
| Email |
shukla.pragya0509@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATIENTS AT TRAUMA CENTER IMS BHU |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE ] |
|
|
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 SANDEEP LOHA |
TRAUMA CENTER INSTITUTE OF MEDICAL SCIENCES BHU |
DEPARTMENT OF ANAESTHESIOLOGY
1ST FLOOR TRAUMA CENTER
IMS, BHU
VARANASI
Varanasi
UTTAR PRADESH |
8960919866
drsandeepscb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE BANARAS HINDU UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S520||Fracture of upper end of ulna, (2) ICD-10 Condition: S521||Fracture of upper end of radius, (3) ICD-10 Condition: S522||Fracture of shaft of ulna, (4) ICD-10 Condition: S523||Fracture of shaft of radius, (5) ICD-10 Condition: S525||Fracture of lower end of radius, (6) ICD-10 Condition: S526||Fracture of lower end of ulna, (7) ICD-10 Condition: S510||Open wound of elbow, (8) ICD-10 Condition: S518||Open wound of forearm, (9) ICD-10 Condition: S500||Contusion of elbow, (10) ICD-10 Condition: S501||Contusion of forearm, (11) ICD-10 Condition: S503||Other superficial injuries of elbow, (12) ICD-10 Condition: S508||Other superficial injuries of forearm, (13) ICD-10 Condition: S424||Fracture of lower end of humerus, (14) ICD-10 Condition: S481||Traumatic amputation at level between shoulder and elbow, (15) ICD-10 Condition: S621||Fracture of other and unspecifiedcarpal bone(s), (16) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A- ADDITION OF NEOSTIGMINE TO ISOBARIC 0.25% BUPIVACAINE |
GROUP A- 0.25% Bupivacaine 35mg (14ml) with Neostigmine 250 mcg (1ml) is given. Onset of sensory block to level C5-T1 dermatome (hollmans scale grade2), onset of motor blockade to Bromage scale 1,regression of sensory(hollmans scale grade1), return of motor activity to Bromage 0 level and total duration of analgesia will be recorded |
| Comparator Agent |
GROUP B- ADDITION OF FENTANYL TO ISOBARIC 0.25% BUPIVACAINE |
GROUP B- 0.25% Bupivacaine 35mg (14ml) with Fentanyl 50 mcg (1ml) is given. Onset of sensory block to level C5-T1 dermatome (hollmans scale grade2), onset of motor blockade to Bromage scale 1,regression of sensory(hollmans scale grade1), return of motor activity to Bromage 0 level and total duration of analgesia will be recorded |
| Intervention |
USG GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK |
Place the ultrasound probe in the supraclavicular fossa in a transverse orientation, to visualize the brachial plexus near the subclavian artery. Insert a block needle in-plane from posterior to anterior and lateral to medial aiming for the deep portion of the brachial plexus where it overlies the first rib.
Confirm negative aspiration then inject a small amount of local anesthetic with the goal of raising the plexus off of the first rib.
Advance the needle along the first rib to the anterior aspect of the plexus, adjacent to the subclavian artery. Confirm negative aspiration, then inject the remaining drug with repeated negative aspiration and confirm by hydrodissection. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS POSTED FOR UPPER LIMB FRACTURE SURGERIES OF PROBALE DURATION OF 2 HOURS
ASA I & II
|
|
| ExclusionCriteria |
| Details |
PATIENTS REFUSAL
ALLERGY TO LOCAL ANAESTHETICS & USED ADJUVENTS
LOCAL SITE INFECTION
NEURODEGENERATIVE DISORDERS IN UPPER LIMB
BLEEDING COAGULOPATHY
PATIENT WITH HEPATIC & RENAL DISORDERS
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DURATION OF ANALGESIA |
AFTER 2 HOUR EVERY 10 MIN POSTOPERATIVELY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DURATION OF SENSORY AND MOTOR BLOCK |
AFTER 2 HOUR EVERY 10 MIN POSTOPERATIVELY |
|
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/01/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed to To find out the comparative efficacy of bupivacaine with fentanyl vs bupivacaine with neostigmine for onset, duration of sensory and motor block with duration of analgesia. To observe side effects of drugs among the different groups.
Fentanyl has been used for regional nerve plexus blocks to improve the block duration and quality. The peripheral administration of opioids provides effective and long lasting analgesia without central side effects.Studies have shown better block duration and success rate of brachial plexus block on addition of fentanyl. Whereas neostigmine decreases the breakdown of acetylcholine by its inhibitory action on acetylcholinesterase, preclinical data suggests peripheral anti-nociceptive effects of acetylcholine due to its accumulation, resulting prolongation of nerve block with hemodynamic stability.
We hypothesized that peripheral nerve block with isobaric 0.25% bupivacaine and Fentanyl would be comparable to isobaric 0.25% bupivacaine and Neostigmine for the efficacy of anesthesia and analgesia, and in addition would provide a better postoperative recovery profile and readiness for discharge. |