| CTRI Number |
CTRI/2019/09/021013 [Registered on: 02/09/2019] Trial Registered Retrospectively |
| Last Modified On: |
27/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of nalbuphine and fentanyl as additives to bupivacaine in spinal anaesthesia in patients undergoing TURP surgery |
|
Scientific Title of Study
|
A comparative study of intrathecal nalbuphine versus intrathecal fentanyl as an adjuvant to bupivacaine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palavi Garg |
| Designation |
junior resident |
| Affiliation |
Dayanand Medical College and Hospital, |
| Address |
department of anaesthesia, first floor,
Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana.
Ludhiana
PUNJAB
141001
India |
| Phone |
9888530401 |
| Fax |
|
| Email |
garg_palavi88@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamakshi Garg |
| Designation |
Associate Professor |
| Affiliation |
Dayanand Medical College and Hospital, |
| Address |
department of anaesthesia, first floor,
Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana.
Ludhiana
PUNJAB
141001
India |
| Phone |
9814444121 |
| Fax |
|
| Email |
drkamakshigarg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Palavi Garg |
| Designation |
junior resident |
| Affiliation |
Dayanand Medical College and Hospital, |
| Address |
department of anaesthesia, first floor,
Dayanand Medical College and Hospital, Tagore Nagar, Ludhiana.
Ludhiana
PUNJAB
141001
India |
| Phone |
9888530401 |
| Fax |
|
| Email |
garg_palavi88@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| department of anaesthesia,first floor, dayanand medical college and hospital, ludhiana |
|
|
Primary Sponsor
|
| Name |
department of anaesthesia dayanand medical college and hospital |
| Address |
dayanand medical college and hospital, tagore nagar, ludhiana |
| 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 |
| palavi garg |
DAYANAND MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIA, FIRST FLOOR, DAYANAND MEDICAL COLLEGE AND HOSPITAL,
LUDHIANA
Ludhiana
PUNJAB |
9888530401
garg_palavi88@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICS COMMITTEE,DMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I AND II PATIENTS UNDERGOING ELECTIVE TURP SURGERIES , (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NALBUPHINE |
SEMI SYNTHETIC OPIOID, KAPPA AGONIST WITH ADEQUATE DURATION OF SENSORY AND MOTOR BLOCK AND PROLONGED POST OPERATIVE PERIOD OF ANALGESIA WITH MINIMAL SIDE EFFECTS. IT CAN BE GIVEN INTRATHECALLY AND INTRAVENOUSLY AS WELL.
A DOSE OF 0.8 mg HAS BEEN GIVEN AS ADJUVANT TO BUPIVACAINE, INTRATHECALLY. THE TOTAL DURATION OF
THERAPY WAS TAKEN AS FROM THE TIME OF SPINAL INJECTION TILL THE TIME WHEN PATIENT FIRST COMPLAINS OF PAIN IN THE POSTOPERATIVE PERIOD AS A MEASURE OF DURATION OF POSTOPERATIVE ANALGESIA. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
ASA grade I and II |
|
| ExclusionCriteria |
| Details |
1. ASA grade III or more
2. Patients refusal for subarachnoid block.
3. Patients on anticoagulant medication.
4. History of anaphylaxis to local anaesthetics.
5. Infection at site of injection.
6. patient with spinal deformities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. onset and duration of sensory block level.
2. onset and duration of motor block level.
3. evaluating haemodynamic parameters.
|
onset of sensory and motor block level and haemodynamic parameters to be evaluated every 5 minutes for first 15 minutes and then every 15 minutes for 90 minutes intraoperatively. Duration of sensory and motor block assessed for the next 6hours and hemodynamic paramerters for the next 24 hours in the postoperative period.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of post operative analgesia.
2. Side effect profile with each drug.
|
duration of postoperative analgesia to be recorded from the point of spinal injection till the patient first demands rescue analgesia.
side effects to be noted both intraoperatively as well as postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
11/02/2016 |
| Date of Study Completion (India) |
20/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS STUDY WAS CONDUCTED IN RANDOMIZED, DOUBLE CONTROLLED MANNER ON A TOTAL OF 60 ASA GRADE I & II PATIENTS POSTED FOR TURP SURGERY UNDER SUBARACHANOID BLOCK USING BUPIVACAINE AS THE LOCAL ANAESTHETIC DRUG. THE DRUGS FENTANYL AND NALBUPHINE WERE USED AS ADJUVANTS TO BUPIVACAINE FOR COMPARATIVE EVALUATION OF EACH IN TERMS OF ONSET AND DURATION OF MOTOR AND SENSORY BLOCK AND CHANGES IN HAEMODYNAMIC PARAMETERS INTRAOPERATIVELY AS WELL AS POSTOPERATIVELY. ALSO, THE POSTOPERATIVE ANALGESIA AND SIDE EFFECT PROFILE IN BOTH THE GROUPS WERE RECORDED. ALL THE OBSERVATIONS WERE TABULATED AND SENT FOR STATISTICAL EVALUATION. |