| CTRI Number |
CTRI/2017/07/009057 [Registered on: 17/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Nalbuphine as an addition to Bupivacaine in Supraclavicular block for Upper Limb Orthopedic Surgeries. |
|
Scientific Title of Study
|
“Clinical evaluation of Nalbuphine as an adjuvant to local anaesthetic in Supra Clavicular Brachial Plexus Block for Upper Limb Orthopedic Surgeris: A Prospective, Randomized, Double Blind Study.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshali Bhavsar |
| Designation |
second year resident |
| Affiliation |
Govt. Medical College, Bhavnagar |
| Address |
Department of Anaesthesiology,
Government Medical College And Sir Takhatsinhji Hospital,Bhavnagar.
Bhavnagar GUJARAT 364001 India |
| Phone |
9913517989 |
| Fax |
|
| Email |
harshalibhavsar44@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Komal Shah |
| Designation |
Assossiate Professor |
| Affiliation |
Govt. Medical College And Sir Takhtsinhji Hospital, Bhavnagar |
| Address |
Department Of Anaesthesiology,
Government Medical College Sir Takhatsinhji Hospital, Bhavnagar
Bhavnagar GUJARAT 364001 India |
| Phone |
9913517989 |
| Fax |
|
| Email |
shah.komal@rediff.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Komal Shah |
| Designation |
Assossiate Professor |
| Affiliation |
Govt. Medical College And Sir Takhtsinhji Hospital, Bhavnagar |
| Address |
Department of Anaesthesiology, Government Medical College And Sir Takhatsinhji Hospital,
Bhavnagar
Bhavnagar GUJARAT 364001 India |
| Phone |
9913517989 |
| Fax |
|
| Email |
shah.komal@rediff.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology, Govt. Medical College, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology And Sir Takhatsinhji Hospital |
| Address |
Department Of Anaesthesiology,
Government Medical College And Sir Takhatsinhji Hospital,
Jail Road,
Bhavnagar-364001
Gujarat |
| Type of Sponsor |
Government medical college |
|
|
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 Harshali Bhavsar |
Government Medical College And Sir Takhatsinji Hospital, Bhavnagar |
Department Of Anaesthsiology,
Government Medical College And Sir Takhatsinhji Hospital,
Jail Road,
Bhavnagar 364001,
Bhavnagar GUJARAT |
09913517989
harshalibhavsar44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee,Government Medical College, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients posted for upper limb orthopaedic surgery of 18 to 60 yrs of age belonging to ASA I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUPIVACAINE, NORMAL SALINE |
DOSE- BUPIVACAINE 25 ML
NORMAL SALINE 5 ML
FREQUENCY-SINGLE TIME
ROUTE- SUPRACLAVICULAR
BRACHIAL PLEXUS BLOCK
DURATION-24 HOURS AFTER
BLOCK |
| Intervention |
Bupivaciane, nalbuphine |
DOSE-Bupivacaine(0.5%)25 ml
nalbuphine 20 mg DILUTED UPTO 5 ML OF NORMAL SALINE
FREQUENCY-SINGLE TIME
ROUTE- SUPRACLAVICULAR
BRACHIAL PLEXUS BLOCK
DURATION-24 HOURS AFTER
BLOCK |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Informed written consent for participation in study.
Gender: Either gender.
Patients scheduled for elective upper limb orthopedic surgery
ASA physical status I and II.
BMI ≤ 25kg/m2.
|
|
| ExclusionCriteria |
| Details |
1.Patients refusing consent.
2.Contraindications to regional anesthesia:
Previous nerve injury.
History of drug dependence/abuse.
History of drug allergy.
Allergic to local anaesthetics.
Patients taking analgesics and sedatives.
Patients on anticoagulants.
History of bleeding disorders.
Psychiatric illness.
Uncooperative patients.
3.Any major systemic illness like hypertension, heart block etc.
4.Antenatal females and lactating mother.
5.Inadequate effect requiring supplementation.
6.ASA physical status III and above.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Onset, peak and duration
of sensory blockade.
2.Onset, peak and duration
of motor blockade.
3.Duration of effective
post-operative analgesia.
4.Total dose and frequency
of rescue analgesics
required in 24 hours.
5.Ramsey Sedation score. |
baseline and than 1 min,3 min,5 min,10 min,15
min,30 min, 1 hour,2 hour, 3 hour, 4 hour and
every 2 hourly till 24 hours after brachial block
Secondary |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Effects on hemodynamic
variables Heart Rate,
Mean Arterial Blood andperipheral oxygen
saturation. |
baseline and than 1 min,3 min,5 min,10 min,15
min,30 min, 1 hour,2 hour, 3 hour, 4 hour and
every 2 hourly till 24 hours after brachial block |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/02/2017 |
| 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="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
After institutional review board approval (IRN NO: 631/2016) and written informed consent from patient, this prospective randomized double-blinded clinical trial is being carried out in 100 patients. After thorough preanaesthetic evaluation patients are allocated into two groups according to inclusion and exclusion criteria. Patients are randomized to one of the two groups of 50 patients each by computer generated random number sequence. Group N (n = 50) – Bupivacaine(0.5%) 25 cc + Nalbuphine 20 mg diluted upto 5 ml of normal saline Group C(n = 50) – Bupivacaine(0.5%) 25 cc + 5 ml normal saline In preanaesthetic preparation Room, standard monitoring for Heart Rate (ECG), Mean arterial blood pressure (NIBP), Peripheral oxygen saturation (SpO2) are established and baseline vital parameters are recorded. Patients are educated for subjective reporting of pain using 10 points visual analogue scale (VAS) where ‘0’ represents no pain and ‘10’ represented the worst pain possible. An appropriate size i.v. Cannula is secured and DNS infusion is started slowly. Injection Ondansetron 0.08 mg/kg is given as premedication 15 minutes before induction. In the preoperative preparation room only, patients are randomized to one of the two study groups by computer generated random number sequence. The doctor performing the randomization, prepared the solution as per the group assigned and no other member of the research team knows about the contents of the solution. In the operation theatre, we perform supraclavicular brachial plexus block with the aid of Nerve locator (B. BRAUN Company). After giving the position for supraclavicular brachial plexus block, a 22G short beveled 1.5 inch insulated needle is introduced just lateral to subclavian artery pulsation 1 cm above the mid-point of clavicle and advanced in backward, inward and downward direction. The current is initially set to deliver 0.5 milliamperes (mA) at 2Hz stimulation frequency. The needle is advanced till we get contraction of forearm muscle. Once the contraction is seen, current is reduced in 0.02 mA decrements while advancing the needle till we get maximum contraction with minimum possible current. At this point, the solution as per the group assigned is injected after careful aspiration so as to avoid intravascular injection of drug.The doctor performing the block is unaware of the drug combination administered. End of the injection is taken as Time ’0’. Immediately after the block, sensory and motor characteristics of blockade, hemodynamic variables, SpO2 are assessed by the same doctor who performs the block at 1, 3, 5, 10, 15, 30 minutes,1 hour, 2 hour, 3 hour, 4 hour and then at two hourly interval for 24 hours. Post operatively the time of first rescue analgesic required at visual analouge score 4 and total analgesic doses given in 24 hours are noted. Diclofenac sodium 1.5 mg/kg i.v. is given as rescue analgesic whenever required (VAS=4).Any complication or adverse event are also noted down. Bradycardia is defined as heart rate <60/min and is treated by inj. Atropine intravenously. Variation in mean arterial pressure 30% on either side of baseline is considered significant and treated accordingly. |