| CTRI Number |
CTRI/2025/03/081915 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the pain reduction effect between two drugs via an injection through the backbone while delivering baby by a cut in the lower abdomen of the mother. |
|
Scientific Title of Study
|
Comparison of hemodynamic disturbances and postoperative analgesia between intrathecal bupivacaine with buprenorphine as adjuvant and intrathecal bupivacaine alone in lower segmental caesarean section: A randomised controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Koushik Baran Roy |
| Designation |
Post Graduate Student |
| Affiliation |
ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital |
| Address |
Department of Anaesthesiology, ICARE Institute of Medical Sciences And Research and Dr Bidhan
Chandra Roy Hospital, Banbishnupur, P.O.-Balughata, Haldia, Purba Medinipur, West Bengal
Medinipur
WEST BENGAL
721645
India |
| Phone |
7003183598 |
| Fax |
|
| Email |
Dr Koushik Baran Roy |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arup Dasgupta |
| Designation |
Professor and H.O.D, Dept. Of Anaesthesiology |
| Affiliation |
ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital |
| Address |
Department of Anaesthesiology, ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital, Banbishnupur, P.O.-Balughata, Haldia, Purba Medinipur, West Bengal
Medinipur
WEST BENGAL
721645
India |
| Phone |
9831009434 |
| Fax |
|
| Email |
arupdg55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arup Dasgupta |
| Designation |
Professor and H.O.D, Dept. Of Anaesthesiology |
| Affiliation |
ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital |
| Address |
Department of Anaesthesiology, ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital, Banbishnupur, P.O.-Balughata, Haldia, Purba Medinipur, West Bengal
Medinipur
WEST BENGAL
721645
India |
| Phone |
9831009434 |
| Fax |
|
| Email |
arupdg55@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital, Banbishnupur, P.O.-Balughata, Haldia, Purba Medinipur, Pin-721645, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Dr Koushik Baran Roy |
| Address |
Department of Anaesthesiology, ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital, Banbishnupur, P.O.-Balughata, Haldia, Purba Medinipur, Pin-721645, West Bengal, India |
| 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 Koushik Baran Roy |
ICARE Institute of Medical Sciences And Research and Dr Bidhan Chandra Roy Hospital |
Department of Obstetrics and Gynaecology, ICARE Institute of Medical Sciences And Research
and Dr Bidhan Chandra Roy Hospital, Banbishnupur, P.O.-Balughata, PIN-721645, Haldia, Purba Medinipur
Medinipur
WEST BENGAL |
7003183598
drkoushikbaranroy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IIMSAR Haldia |
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 |
Inj. Bupivacaine Hydrochloride (0.5 percent) (hyperbaric),
Inj. Buprenorphine Hydrochloride (0.3mg/ml) (preservative free) |
Intrathecally 10mg [2.0ml] Inj. Bupivacaine Hydrochloride (0.5
percent) (hyperbaric) with preservative free Inj. Buprenorphine Hydrochloride 60mcg [0.2ml] (preservative free) |
| Comparator Agent |
Inj. Bupivacaine Hydrochloride (0.5 percent) (hyperbaric), 0.9%
Sodium Chloride |
Intrathecally 10mg [2.0ml] Inj. Bupivacaine Hydrochloride (0.5
percent) (hyperbaric) with 0.9% sodium chloride [0.2ml] |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Term (more than 37 weeks) pregnant women,
Pregnant women (ASA grade II including women with mild PIH and controlled gestational diabetes) posted for elective caesarean section under spinal anaesthesia,
Patients willing for elective caesarean section,
Those who can give valid informed written consent for participation. |
|
| ExclusionCriteria |
| Details |
Patients not willing to give consent,
Known allergy to amide local anaesthetics and buprenorphine,
Patients with contraindications to subarachnoid block,
patients with -
cardiovascular disease,
severe preeclampsia,
uncontrolled gestational diabetes,
preexisting neurological disease
Deformities of spinal column in severe degree,
Less than 18 years or more than 35 years of age,
ASA grade III and above,
Failed spinal anaesthesia,
Antepartum haemorrhage,
Morbid obese (BMI more than equals to 40)
|
|
|
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 |
| Duration of postoperative analgesia |
From the time of end of surgery till the first demand of rescue analgesic. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate |
Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours. |
| Systolic Blood Pressure |
Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours |
| Diastolic Blood Pressure |
Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours |
| Mean Arterial Pressure |
Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours |
| Oxygen Saturation (SPO2) |
Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours |
| Respiratory Rate |
Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours |
| APGAR Score (Neonatal status) |
At 1 min,then 5 min after delivery |
| Visual Analogue Score (Level of pain) |
Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then 6 hourly thereafter till 24 hours. |
| Ramsay Sedation Score (Level of sedation) |
Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours |
| Pinprick method (Level of sensory block) |
Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours (till 2 segment regression from maximum level) |
| Modified Bromage Score (Level of motor block) |
Intraoperatively every 5 min for first 30min, then every 10 min till the end of surgery. Postoperatively every 30 min till 3 hours, then hourly till 6 hours, then every 6 hourly thereafter till 24 hours |
| Pruritus |
From the time of intrathecal injection till 24 hours after surgery. |
| Nausea |
From the time of intrathecal injection till 24 hours after surgery. |
| Vomiting |
From the time of intrathecal injection till 24 hours after surgery. |
| Total amount of vasopressor required |
From the time of intrathecal injection till 24 hours after surgery. |
| Total no. of topup rescue analgesic required |
From the time of intrathecal injection till 24 hours after surgery. |
| Shivering |
From the time of intrathecal injection till 24 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
31/03/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective,
double blinded, parallel group, randomized controlled, tertiary centre trial
comparing the duration and efficacy of postoperative analgesia between
preservative free low dose (60 mcg) intrathecal buprenorphine hydrochloride as adjuvant
to (10 mg) 0.5 percent hyperbaric bupivacaine versus (10 mg) intrathecal 0.5 percent hyperbaric
bupivacaine alone to determine the better effective study arm in terms of
achieving better postoperative analgesia and patient satisfaction with least
side effects in women undergoing elective caesarean section.
The primary
outcome will be the total duration of postoperative analgesia.
The secondary
outcomes will be the followings-
- Hemodynamic response
- Complications (eg. pruritus, nausea
and/or vomiting, respiratory depression)
- 24-hour postoperative pain (Visual
Analogue Score)
- Level of Sedation (Ramsay Sedation
Score)
- APGAR score (status of the
neonate)
|