| CTRI Number |
CTRI/2025/10/095551 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two local anaesthetic drugs in Supraclavicular brachial plexus block in patients scheduled for upper limb surgeries |
|
Scientific Title of Study
|
comparative study of Nalbuphine and Butorphanol as adjuvant to 0.75%Ropivacaine in Supraclavicular brachial plexus block in patients posted for upper limb surgeries-a double blinded randomized controlled trail |
| 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 Jebisha |
| Designation |
Post graduate |
| Affiliation |
sri manakula vinayagar medical college and hospital |
| Address |
PG Quarters phase-1
sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet
pudhucherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003543002 |
| Fax |
|
| Email |
jebishaindia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suneeth P Lazarus |
| Designation |
Head of Department |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Room No 106
Sri Manakula Vinayagar Medical College and Hospital
kalitheerthalkuppam
Madagadipet
pudhucheery
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894332543 |
| Fax |
|
| Email |
lazarus.suneeth@gmail.comn |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jebisha |
| Designation |
Post graduate |
| Affiliation |
sri manakula vinayagar medical college and hospital |
| Address |
PG Quarters phase-1
sri manakula vinayagar medical college and hospital
kalitheerthalkuppam
madagadipet
pudhucherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003543002 |
| Fax |
|
| Email |
jebishaindia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula Vinayagar medical college and hospita,kalitheerthalkuppam,madagadipet,pondicherry-605107,india. |
|
|
Primary Sponsor
|
| Name |
Dr Jebisha |
| Address |
Room no:107,Department of Anaesthesia,Sri Manakula Vinayagar Medical College and Hospital,Kalitheerthalkuppam,Madagadipet,Puducherry-605107,India |
| Type of Sponsor |
Other [self] |
|
|
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 Jebisha |
sri manakula vinayagar medical college and hospital |
107,Department of anaesthesia ,kalitheerthalkuppam, madagadipet,puducherry-605107
Pondicherry
PONDICHERRY |
9003543002
jebishaindia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH- ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1 ml of 1 mg Butorphanol + 20 ml of 0.75 % Ropivacaine |
1 ml of 1 mg Butorphanol + 20 ml of 0.75 % Ropivacaine is given for supraclavicular Brachial plexus Block in upper limb surgeries |
| Intervention |
1 ml of 10 mg Nalbuphine + 20 ml of 0.75 % Ropivacaine |
1 ml of 10 mg Nalbuphine + 20 ml of 0.75 % Ropivacaine is given for supraclavicular brachial plexus block in patients posted for upper limb surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- ASA PS class 1 and 2
- Age 18 to 60 years
- Weight more than 50 years |
|
| ExclusionCriteria |
| Details |
- Presence of coagulopathy, neuropathy, active infection at site, allergic to Local anesthetics.
- BMI more than 35 kg per square meters
- pregnancy, severe mental illness |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of sensory blockade of Nalbuphine and Butorphanol as adjuvants to 0.75% Ropivacaine in supraclavicular brachial plexus block in patients undergoing upper limb surgeries |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To compare the Hemodynamic parameters and adverse effects of both the adjuvants
-To compare the time of first Rescue analgesia administered over 24 hours in both the groups |
10,20,30,40,50mins |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - jebishaindia@gmail.com
- For how long will this data be available start date provided 30-12-2026 and end date provided 18-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Nil per oral for 6 hours before surgery. Pre medicated with tablet Alprazolam 0.5mg and tablet Pantoprazole 40mg on the night
before surgery. Informed written consent for participation in the study will be obtained from each
patient. Patient data will be recorded in the proforma. Details regarding age, sex, contact
information, comorbidities, airway assessment and ASA class will be recorded. Enrolled
patients will be allotted to one of the groups (A or B). Based on the randomization sequence, the patients will be allocated into two groups,
Group A and Group B. Group N patient will receive 20 ml of 0.75%Ropivacaine + 1 ml
(10 mg) Nalbuphine and patients belonging to group B will receive 20 ml of 0.75%
Ropivacaine + 1 ml (1 mg) Butorphanol
After shifting the patient to operation theatre, the ASA standard monitors like ECG,
Noninvasive blood pressure (NIBP), SpO2 will be connected and baseline readings will be
noted. Strict aseptic precautions will be followed. Blocks will be performed under
ultrasound guidance. Ultrasonography machine (Sonosite Edge I ultrasound system) with a
high frequency linear array probe (6-13MHz) will be used. Patient will be lying supine and
head tilted to opposite side, in both the study groups. For each patient, Inj. Midazolam 0.02
mg/kg IV will be administered and supplemental oxygenation via a simple face-mask at the
rate of 4L/min will be administered before performing the block. Blocks in both groups will
be performed using a local anesthetic of 20ml of 0.75% Ropivacaine. In the transverse
orientation, the probe is placed in the supra clavicular region, approximately 3cm above the
midclavicular point. At this site, the third part of SCA will be visible. The probe is toggled
in cephalocaudal direction to see SCA and its cross section, along with the three trunks of
brachial plexus (hyper-echoic structures) resting on the first rib. After obtaining an adequate
sonographic view, a 5 cm, 22 -gauge needle (Stimulex D; B. BRAUN AG) will be inserted
in line from the lateral to medial orientation through single skin puncture.
Sensory evaluation will be done using pin prick stimulation in the areas supplied by the
radial nerve- dorsum of hand, median nerve- thenar eminence, ulnar nerve- hypothenar
eminence and musculocutaneous nerve - lateral aspect of the forearm by 3-point scale10. At
each point of assessment, a score of 0-2 will be given to each territory
Grade 0 – normal sensation
A complete sensory blockade of each nerve is defined as a pinprick score of 2.
Grade 1 – loss of pain sensation, but pressure sensation intact
Grade 2 – loss of both pain and pressure sensation.
The motor evaluation is done by elbow flexion (musculocutaneous nerve), third finger
flexion (median nerve), thumb abduction (radial nerve) and little finger flexion (ulnar
nerve). At each point of assessment, a Modified Bromage scale5
is used to grade motor
blockade.
1. Able to raise the extended arm to 90 degrees for a full two seconds.
2. Able to flex the elbow and move the fingers but unable to raise the extended arm
3. Unable to flex the elbow but able to move the fingers
4. Unable to move the arm, elbow or the fingers.Grade 2 corresponds to onset of motor blockade and Grade 3 onwards was taken as complete
blockade.
A complete motor blockade for each nerve is defined as a score of 0. Block performance
time is defined as the time (in minutes) from the point of needle insertion till the removal of
the needle after drug deposition. We considered the block successful and the patient ready
for surgery when a complete sensory and motor blockade is achieved in all four territories
and time to readiness for surgery is recorded. In case of block failure or insufficient block,
the patients are administered general anesthesia with standard institutional protocol, and
surgery proceeded and such cases will be excluded from statistical analysis.
After the surgery, patients will be instructed to repeatedly pinch the little finger of each hand
using their non-blocked hand and report for the time of sensory normalization in the
anaesthetized hand by comparison with the opposite hand. Patients will be followed up for
24hrs post surgery and looked for residual blockade and neurological deficits.
The patient and the postoperative ward staff will be instructed to note the time of return of
pain postoperatively which will be verified by the investigator. Blood Pressure (Systolic,
Diastolic and Mean Arterial Pressure), heart rate and Peripheral oxygen saturation of the
patient will be recorded every 10 minutes from 30mins before the procedure and every 5
minutes after the block for first 30mins and every one hour for next 6 hours or after the end
of the surgery and every fourth hourly thereby up to 24 hours after the surgery. Injection
Atropine 0.6 mg is given intravenously if the heart Rate decreases below 40 bpm and
injection Ephedrine 6 mg will be given intravenously if the Mean Arterial Pressure decreases
less than 60 mmHg.
The occurrence of postoperative pain will be assessed by the Visual Analogue Score at 2nd
hour, 4th hour, 6th hour, 8th hour, 12th hour, 16th hour, 20th hour and 24th hour after the
procedure and whenever patient complains of pain. VAS score of >4 will be considered
significant and rescue analgesia Inj. Tramadol 1 mg/kg IV stat will be given, the duration of
action of drug is determined by onset of action to first rescue analgesia. |