| CTRI Number |
CTRI/2023/03/050389 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The rationale of study is that which one among Nalbuphine and Buprenorphine,is a better adjuvant yet to be explored as only few studies happened in past on this |
|
Scientific Title of Study
|
Hyperbaric Bupivacaine with Nalbuphine and Buprenorphine Intrathecally for Postoperative Analgesia in Lower Abdominal and Lower Limb Surgeries : A Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarfaraz Ahmad |
| Designation |
Associate Professor |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , BAREILLY |
| Address |
Red building Anesthesia Department Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7088833111 |
| Fax |
|
| Email |
sarfaraz_ahm2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarfaraz Ahmad |
| Designation |
Associate Professor |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , BAREILLY |
| Address |
Red building Anesthesia Department Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7088833111 |
| Fax |
|
| Email |
sarfaraz_ahm2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DHARIWAL RAHUL GAJPAL SINGH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , BAREILLY |
| Address |
ROOM NUMBER 17 , PG BOYS HOSTEL ,ROHILKHAND MEDICAL COLLEGE AND HOSPITAL ,PILIBHIT BYPASS ROAD , BAREILLY - 243006
RED BUILDING ANESTHESIA DEPARTMENT, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL , PILIBHIT BYPASS ROAD , BAREILLY- 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8266991889 |
| Fax |
|
| Email |
drrahulsinghdhariwalmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Rohilkhand Medical College And Hospital Pilibhit Bypass Road Bareilly 243006 |
| Type of Sponsor |
Private 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 Sarfaraz Ahmad |
OPERATION THEATRE , Rohilkhand Medical College And Hospital |
DEPARTMENT OF ANESTHESIOLOGY , BAREILLY, UTTARPRADESH
Bareilly
UTTAR PRADESH |
7088833111
sarfaraz_ahm2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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 |
Hyperbaric Bupivacaine with Buprenorphine Intrathecally in Lower Abdominal and Lower Limb Surgeries |
0.5% Bupivacaine hyperbaric (2.5 ml ) and Buprenorphine 45 mcg in 0.45 ml normal saline |
| Intervention |
Hyperbaric Bupivacaine with Nalbuphine intrathecally in Lower Abdominal and lower limb surgeries |
0.5% Bupivacaine hyperbaric (2.5 ml) and Nalbuphine 0.6 mg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologists (ASA) grade 1 or 2
Posted for surgeries of lower abdomen or lower limb of different surgical specialities |
|
| ExclusionCriteria |
| Details |
Patient refusal for procedure
Any Neuropathy,Cardiac disease,diabetes,Nephropathy,Coagulopathy
Any known allergy to local anaesthetic
Patients with contraindications for spinal anaesthesia such as derranged coagulation profile ,raised ICP,local infection at site of needle insertion |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset of sensory and motor block
Duration of sensory and motor block
Duration of postoperative analgesia
|
At 2,4,6,8,10,12,14,16,18,20,30,40,50,60,90,120,180,240,360,720 minutes after block , heart rate ,ECG lead 2 ,systolic , diastolic and mean blood pressure and oxygen saturation will be recorded
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic responses to the drug during and after surgery
Any complication or side effects |
At 2,4,6,8,10,12,14,16,18,20,30,40,50,60.90,120,180,240,360,480,720 minutes after the block , heart rate ,ECG lead 2,systolic,diastolic and mean blood pressure and oxygen saturation will be recorded |
|
|
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)
|
12/03/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Subarachnoid block is used in lower abdominal and lower limb surgeries for post operative pain relief. Opiod drugs have been used along with Bupivacaine and other local anaesthetics in subarachnoid block for prolongation of effect of analgesia and to minimise the requirement of postoperative analgesia
Bupivacaine is an amino amide anesthetic binds to intracellular portion of voltage gated sodium channels and blocks sodium influx into nerves cells which prevent depolarisation so no initiation or conduction of pain signal occur
Buprenorphine is derivative of opiod alkaloid thebaine , provide good intraoperative and postoperartive analgesia. Nalbuphine is highly lipid soluble kappa receptor agonist and mu receptor anatagonist The Rationale of study is that which among Nalbuphine and Buprenorphine is better adjuvant yet to be explored and only few studies happened in past on it |