| CTRI Number |
CTRI/2021/11/038007 [Registered on: 12/11/2021] Trial Registered Prospectively |
| Last Modified On: |
07/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF DIFFERENT DOSES OF NALBUPHINE AS AN ADJUVANT IN SPINAL ANESTHESIA IN LOWER ABDOMEN AND LOWER LIMB SURGERIES |
|
Scientific Title of Study
|
COMPARISON OF DIFFERENT DOSES OF INTRATHECAL NALBUPHINE AS AN ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN SUB-ARACHNOID BLOCK IN LOWER ABDOMEN AND LOWER LIMB SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tavleen Kaur Brar |
| Designation |
Resident |
| Affiliation |
Dr DY Patil Medical College and Hospital, Pimpri, Pune |
| Address |
OPD Building, 5th floor, HiTech OT complex, Department of Anesthesia, Dr DY Patil Medical College and Hospital, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9592911024 |
| Fax |
|
| Email |
tavleenbrar95@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Joshi |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr DY Patil Medical College and Hospital, Pimpri, Pune |
| Address |
OPD Building, 5th floor, HiTech OT complex, Department of Anesthesia, Dr DY Patil Medical College and Hospital, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822053792 |
| Fax |
|
| Email |
smitajoshi6@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Joshi |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr DY Patil Medical College and Hospital, Pimpri, Pune |
| Address |
OPD Building, 5th floor, HiTech OT complex, Department of Anesthesia, Dr DY Patil Medical College and Hospital, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822053792 |
| Fax |
|
| Email |
smitajoshi6@rediff.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, OPD Building, 5th floor, HiTech OT complex, Department of Anesthesia, Dr DY Patil Medical College and Hospital, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Tavleen Kaur Brar |
| Address |
Dr DY Patil Medical College and Hospital, Pimpri, Pune |
| 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 Tavleen Kaur Brar |
OPD Building, HiTech OT, 5th Floor |
OPD Building, 5th floor, HiTech OT complex, Department of Anesthesia, Dr DY Patil Medical College and Hospital, Pimpri, Pune
Pune
MAHARASHTRA |
9592911024
tavleenbrar95@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IESC |
Approved |
|
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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 |
Nalbuphine |
0.2 mg of intrathecal nalbuphine as an adjuvant to 0.5% hyperbaric bupivacaine in subarachnoid block for elective lower abdomen and lower limb surgeries |
| Comparator Agent |
Nalbuphine |
0.4 mg of intrathecal nalbuphine as an adjuvant to 0.5% hyperbaric bupivacaine in subarachnoid block for elective lower abdomen and lower limb surgeries |
| Intervention |
Spinal anesthesia |
After painting and draping of the lumbar area, a 26G Quincke spinal needle will be introduced in L3-L4 intervertebral space. Free and clear flow of CSF will be confirmed and subarachnoid block will be given and study will be done till the surgery lasts and 12 hours in post operative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 60 years of either gender.
2. ASA grade I and II.
3. Patients posted for elective lower abdomen and lower limb surgeries under spinal anaesthesia.
4. Weight of the patient being in normal range for that age and sex.
5. Patients who are not on any antihypertensive, anti-platelet, fibrinolytic or anticoagulant drugs.
6. Haemodynamically stable patients with normal laboratory investigations.
7. Patients who give informed consent and are willing to be a part of the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with pre-existing cardiovascular diseases (IHD, hypertension, valvular heart disease), deranged liver functions or renal functions.
2. Patients with any neurological or psychiatric disorders.
3. Patients with any contraindications for neuraxial block.
4. Patients posted for emergency procedures
5. History of allergy to any of the drugs being used under study
6. Unwilling patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determine the
1-Optimum dose with quicker onset
2-Duration of sensory and motor block
3-Duration of analgesic effect
4-Side effects, if any |
0 secs, 3 mins, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the
1-Onset time of sensory block
2-Onset time of motor block
3-Two segment regression time of sensory block
4-Duration of motor block
5-Duration of effective analgesia
6-To study their side effects if any
|
T1-baseline
T2-3mins,
T3-5 mins,
T4-10 mins,
T5- 15 mins,
T6 - 20 mins,
T7 - 25 mins,
T8 - 30 mins |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/11/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison of two different doses of nalbuphine as an adjuvant to hyperbaric bupivacaine in subarachnoid block for elective lower abdomen and lower limb surgeries and determine the Optimum dose with quicker onset, Duration of sensory and motor block, Duration of analgesic effect, Side effects |