| CTRI Number |
CTRI/2019/02/017756 [Registered on: 21/02/2019] Trial Registered Prospectively |
| Last Modified On: |
03/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of two different drungs as adjuvant to levobupivacaine for spinal anaesthesia in lower limb surgeries. |
Scientific Title of Study
Modification(s)
|
Comparison of Nalbuphine and MgSO4 as an adjuvant to 0.5% Hyperbaric Levobupivacaine in subarachnoid blockade for 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 Savita Kumari |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, BHU, VARANASI. |
| Address |
Department of Anaesthesiology
Institute of Medical Sciences,
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9807777367 |
| Fax |
|
| Email |
savi568smile@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Meena |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Institute of medical sciences,
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9455231073 |
| Fax |
|
| Email |
kvtamn68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Meena |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Institute of medical sciences,
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9455231073 |
| Fax |
|
| Email |
kvtamn68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi- 221005 |
|
|
Primary Sponsor
|
| Name |
IMS BHU |
| Address |
Institite of Medical Sciences, banaras Hindu University, Varanasi 221005 |
| 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 Savita kumari |
Trauma Centre |
Department of anaesthesiology, Institute of Medical sciences(IMS), BHU VaranasI
Varanasi
UTTAR PRADESH |
9807777367
savi568smile@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Faculty of Medicine, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S70-S79||Injuries to the hip and thigh, (2) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (3) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium Suphate |
100 mg Magnesium Sulphate will be administered with 15 mg (0.5%) hyperbaric levobupivacaine for subarachnoid blockade in patients undergoing lower limb surgeries. |
| Intervention |
Nalbuphine |
0.8 mg Nalbuphine wiil be administered with 15 mg (0.5%) hyperbaric levobupivacaine for subarachnoid blaockade in patients undergoing lower limb surgeries. |
| Comparator Agent |
Normal Saline |
0.5 ml Normal saline will be administered with 15 mg (0.5%) hyperbaric levobupivacaine for subarachnoid blockade in patients undergoing lower limb surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1, 2
Patients scheduled to have various lower limb sugeries. |
|
| ExclusionCriteria |
| Details |
Patient who refuse to participate in study.
Patients not opting for subarachnoid block as anaesthetic technique.
Patients with local infection or significant coagulopathy.
Patients with severe cardiopulmonary disease.
Patients with blood volume deficit.
Patients with allergy to local anaesthetics or study drugs.
Patients with long term opioid use.
Patients with Peripheral Neuropathies,scoliosis. |
|
|
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 |
| Level of Sensory blockade |
Minutes 1,3,5,10,15,20,30 and 60. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Full recovery of Sensory blockade |
Hours 6 and 12. |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "135"
Final Enrollment numbers achieved (India)="135" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2019 |
| Date of Study Completion (India) |
31/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Butterworth JF. Local anaesthetics: agents, actions and misconceptions. InAmerican Society of Anesthesiologists’ Annual Meeting 2004 (pp. 1-12).
2. Tiwari AK, Tomar GS, Agrawal J. Intrathecal bupivacaine in comparison with a combination of nalbuphine and bupivacaine for subarachnoid block: A randomized prospective double-blind clinical study. American journal of therapeutics. 2013 Nov 1;20(6):592-5.
3. Mukherjee A, Pal A, Agrawal J, Mehrotra A, Dawar N. Intrathecal nalbuphine as an adjuvant to subarachnoid block: What is the most effective dose?. Anesthesia, essays and researches. 2011 Jul;5(2):171. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will be conducted in Department of Anaesthesiology, IMS, BHU,Varanasi after obtaining written and informed consent and institutional ethical approval. After CTRI registration, 135 patients undergoing lower limb surgeries, age 18 to 60 years will be included. Patients will be excluded from study if patients with local infection or significant coagulopathy, severe cardiopulmonary disease, long term opioid use or with peripheral neuropathies and patient refusal. Patient will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelop technique into three equal groups.
Group (L) will receive 15 mg 0.5% hyperbaric Levobupivacaine plus 0.5 ml 0.9 N Normal saline intrathecally. Group (N) will receive 15 mg 0.5% hyperbaric Levobupivacaine plus 0.8 mg nalbuphine intrathecally. Group (M) will receive 15 mg 0.5% hyperbaric Levobupivacaine plus 100 mg magnesium sulphate intrathecally.
After subarachnoid blockade the patients will be placed in supine position. The dermatome level of sensory blockade will be evaluated bilaterally along the midclavicular line by using analgesia to pinprick with a short bevelled 27- guage needle. Motor block will be evaluated in the lower limb according to a Modified Bromage scale. Motor and sensory block will be recorded at 1,3,5,10,15,20,30 and 60 minutes as well as every 60 minute thereafter until resolution of the block. Onset time to level of sensory block, time to maximum sensory block, time to two segment regression of sensory block, time to full recovery of sensory block and time for recovery of motor block will be recorded. The study will end at 24 hour of subarachnoid blockade after all data has been obtained. |