| CTRI Number |
CTRI/2020/08/027280 [Registered on: 20/08/2020] Trial Registered Prospectively |
| Last Modified On: |
19/08/2020 |
| 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
|
to compare the quality of pain relief with two drugs given in spinal anaesthesia forlower segmemt cesarean section
|
|
Scientific Title of Study
|
A study to evaluate the duration of post operative analgesia using nalbuphine or butorphanol as adjuvant to intrathecal 0.5% bupivacaine compared to 0.5% bupivacaine alone in lower segmemt cesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Gupta |
| Designation |
Professor and Head |
| Affiliation |
SGRDIMSAR |
| Address |
Department of Anaesthesia, SGRDIMSAR, Amritsar
Department of Anaesthesia, Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali |
| Designation |
Associate Prof |
| Affiliation |
SGRDIMSAR |
| Address |
Department of Anaesthesia, SGRDIMSAR, Amritsar
Department of Anaesthesia, Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9872981079 |
| Fax |
|
| Email |
gitzgitz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhvir kaur |
| Designation |
Junior Resident |
| Affiliation |
SGRDIMSAR |
| Address |
Department of Anaesthesia, SGRDIMSAR, Amritsar
Department of Anaesthesia, Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
8053457071 |
| Fax |
|
| Email |
sgrdanaesthesia.academics@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGRDIMSAR |
| Address |
Department of Anaesthesia, SGRDIMSAR, Amritsar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Gupta |
SGRDIMSAR |
Operation Theatredepartment of Anaesthesia,
SGRDIMSAR, Amritsar
Amritsar
PUNJAB |
9814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrathecal administration of study drugs |
Intrathecal administration of study drugs nalbuphine or butorphanol as adjuvant to 0.5% bupivacaine compared to 0.5% bupivacaine alone in lower segmemt cesarean section |
| Comparator Agent |
nalbuphine and butorphanol |
post operative analgesia using nalbuphine or butorphanol as adjuvant to intrathecal 0.5% bupivacaine compared to 0.5% bupivacaine alone in lower segmemt cesarean section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients who are willing to undergo the study.
2.Patients undergoing elective LSCS
3.Patients American Society of Anesthesiology (ASA) Grade II
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patient with Cardiorespiratory problems
3. Patient with Coagulopathy
4. Patient with Neurological disease
5. Patient with Psychological disease
6. Patient with Endocrine disease and allergy to used drugs
7. Contraindication to drugs.
8. Complicated pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate duration of analgesia using 0.5% bupivacaine without or with nalbuphine hydrochloride (400 μg) vs butorphanol (25 μg) as adjuvant for subarachnoid block being given for LSCS. |
From the time the sensory block reaches the maximum level to requirment of first top up at NRS more than or equal to 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Onset, duration motor blockade and the hemodynamic changes in perioperative period.
2. Fetal outcome using APGAR, cord blood ph.
3. Sedation score.
4. Effect of adjuvants on sedation.
5. Doses of rescue analgesia required in 24 hours.
6. Correlation of pain free period to breast feeding and early ambulation to duration of analgesia.
7. Complications related to procedures and side effect of drugs.
|
from the onset of sensory and motor block till 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2020 |
| 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="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
|
Spinal opioids potentiate the effect of
local anesthetic agent providing longer lasting postoperative analgesia. We
compared injection nalbuphine and butorphanol as an adjuvant to bupivacaine
with respect to onset, duration of sensory and motor block, duration of
analgesia, fetal outcome using APGAR and cord blood ph. Total
of 90 patients divided randomly into three groups Group A(n=30)0.5% bupivacaine
10 mg(2ml)with 400μg nalbuphine diluted upto 2.2ml, Group B(n=30)
0.5%bupivacaine 10 mg(2ml) with 25 μg butorphanol diluted upto 2.2ml, Group C(n=30)
0.5%bupivacaine 10 mg(2ml) with normal saline diluted upto 2.2ml. Total volume
injected will be 2.2 ml. |