| CTRI Number |
CTRI/2024/04/065962 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Injection Bupernorphine with intrathecal injection Ropivacaine for intensity of pain relief in Cesarean section patients |
|
Scientific Title of Study
|
Comparison of different doses of injection Bupernorphine with intrathecal injection Ropivacaine in Cesarean section patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Vide BCR-RPD-01, Version no. 2.0, dated 19-09-2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veena Narayan Wetal |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
Department of Anesthesiology and Critical Care, 6th floor, Grant government medical college, Nagpada Department of Anaesthesia, Grant government medical college, Mumbai 400008 Mumbai MAHARASHTRA 400008 India |
| Phone |
7875447697 |
| Fax |
|
| Email |
drveena2307@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Veena Narayan Wetal |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
Department of Anesthesiology and Critical care, 6th floor, Grant government medical college & Sir JJ group of hospitals, Mumbai Grant government medical college, Mumbai 400008 Mumbai MAHARASHTRA 400008 India |
| Phone |
7875447697 |
| Fax |
|
| Email |
drveena2307@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Veena Narayan Wetal |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
Department of Anesthesiology and Critical Care, 6th floor, Grant government medical college, Nagpada, Mumbai Grant government medical college, Mumbai 400008 Mumbai MAHARASHTRA 400008 India |
| Phone |
7875447697 |
| Fax |
|
| Email |
drveena2307@gmail.com |
|
|
Source of Monetary or Material Support
|
| Grant government medical college, Mumbai 400008 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and Critical Care |
| Address |
Grant government medical college & Sir JJ group of hospitals, Mumbai, Maharashtra, India. Pin code 400008 |
| 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 Veena Narayan Wetal |
Sir JJ group of hospitals |
GGMC and Sir JJ group of hospitals, Byculla Mumbai MAHARASHTRA |
7875447697
drveena2307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Grant government medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention - Spinal anaesthesia with intrathecal injection Ropivacaine Comparator agent - Injection Bupernorphine |
Spinal anaesthesia in LSCS patients will be used once on induction of Anaesthesia. Different groups are
Group A: 1.8ml of hyperbaric 0.75% Ropivacaine with 30 microgram injection Bupernorphine
Group B: 1.8ml of hyperbaric 0.75% Ropivacaine with 60 microgram injection Bupernorphine
Group C: 2 ml of hyperbaric 0.75% plain injection Ropivacaine will be used intrathecally for Spinal anaesthesia |
| Intervention |
Intervention - Spinal anaesthesia with intrathecal injection Ropivacaine
Comparator agent - Injection Bupernorphine |
Spinal anaesthesia in LSCS patients will be used once on induction of Anaesthesia. Different doses of additive injection Bupernorphine 30 microgram and 60 microgram will be used to improve the efficacy of intrathecal Ropivacaine;
30u injection Bupernorphine & 60u of injection Bupernorphine with plain injection Ropivacaine will be used intrathecally for Spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing Elective Caesarean section
ASA I/II
Height between 145-160 cm
Pregnant pregnancy weight between 45- 80 kg |
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy; Patients with severe PIH, Pre-Eclampsia or Eclampsia; Patients with hepatic, cardiac, renal or neurological disease.
Patients not willing for spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study effect of intrathecal hyperbaric Ropivacaine 0.75% 2ml compared to intrathecal hyperbaric Ropivacaine 0.75% with two different dosage of Bupernorphine 30ug & 60ug for characteristics of sensory and motor blockade. And also the postoperative analgesia duration and analgesic requirements. |
4 mths |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters
Complications
APGAR score |
3-4 months |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Spinal Anaesthesia is the method of choice for caesarean section especially in casc of clective procedures because it avoids the most common risks associated with G cneral Anacsthesia such as aspiration, difficult intubation and negative effccts of general anaesthetics on the fetus. However, certain side effects may also result from spinal anaesthesia, common being hypotension caused by the preganglionic sympathetic block. A decrease in systolic pressure can compromise uterine blood flow and fetal circulation, and thus cause fetal hypoxia and acidosis
Ropivacaine has been introduced for clinical use in 1996 (2009 in India). It isa amide pure S-type I-hydrochloric acid isomer and has low central nervous system toxicity and cardiotoxicity. In moderate drug concentrations, ropivacaine can produce the separation of mctor and sensory nerve block , Domestic studies have shown that a total dose of 10-22.5 mg of 0.5% ropivacaine is safe and reliable, and a lower dose should be selccted for older patients . This anesthesia scheme has the advantages ,of satisfactory analgesia, stabłe intraoperative hemodynamics, a low incidence of postoperative complications and early ambulation postoperatively"".
Opioids remain the mainstay among the various adjuvants to local anesthetics (LAs) in SAB primarily by virtue of its various properties such as reducing thc dose cf LA, minimizing side cffects, and prolonging the duration of anesthesia. American Society of Anesthesiologists (ASA) recommends neuraxial opioids over intermittent administration of parcntcral opioids for postoperative anaigesia after neuraxial anesthesia for caesarcan section." As sInaller doses are used intrathecally, neonatal drug transfer is negligible conıpared to epidural or parenterai opioids*". To overcome disadvantages like spinal hypotension and shivcring many kind of adjuvants have been used intrathecally like fentany sufentanil, dexmedetomidine0, buprenorphine,,,), Nalbuphine,0 clonidine etc. for spinal anaesthesia in LSCS patients. Different additives have been used to improve the efficacy of intrathecal Ropivacaine. However these adjuvants ure associated with urdesired side effects.
Buprenorphine is an agonist-artagonist opioid, about thirty times more potent tỉhan morplıine. It is a -centrally acting iipid soluble analog of the alkaloid thebainc with both spina! and supraspinal coinpoıents of anaigesia. In addition, it has a ceiling cfiect on respiratory depression but not on analgesia. The antihyperalgesic property of buprencrphine helps in preventing centra! sensitization. Its high lipid solubity, high affinity for epioid receptors, and long duration of action makes buprenorphine a good choice as an adjuvant to intrahecal LA for managing moderate to severe postoperat:ve pain. Buprenorphine is readily available as a preservative-free preparation which is compatible with the cerebrospinal fluid (CSr). Intrathecal doses (30 ug-150 ug) arc much smaller than parenieral doses and are known to prolong analgesia without sensory or motor blockade. Being more lipophilic than morphine, buprenorphine has low medullary bioavailability after neuraxial administration so that the occurrence of side cffects is lesser, making it an attractive altenative2)
Postoperative pain is a major causc of fear and anxiety in hospitalized patients and so if patients reinain pain-free during this period, they can cooperate with the circumstances well, leading to early recovery. Over the last two decades, there has been considerable revival of interest in the use of regional anesthesia techniques for surgery and pain management. Yet a gold standard method has not been determined which will have all desired effects during caeserean section without much of adverse effects on maternal and neonatal morbidity.
In this study, optimal dose of Bupcrnorphine which provides a balance betwecn analgesia and adverse effects was been studied in patients for cesarean section. The aim of this study was to compare the efficacy of two doscs uf buprenorphine (30 ug and 60 ug) as an adjuvant to hyperbaric Ropivacaine for postopcrative analgesia in cesarean section. The side cffect profile of neuraxial buprenorphine on the mother and the newbom in the early postopcrative period was also assessed. |