| CTRI Number |
CTRI/2024/07/071076 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of ropivacaine with fentanyl in spinal regional anaesthesia in elective lower segment caesarean section surgeries. |
|
Scientific Title of Study
|
A comparative of intrathecal isobaric ropivacaine 0.5 percent with fentanyl versus isobaric ropivacaine 0.5 percent in elective lower segment caesarean section surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayush Satishkumar Gupta |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital, Jaipur |
| Address |
Mahatma Gandhi University of Medical Sciences and Technology
RIICO Institutional Area
Sitapura, Tonk Road,
Jaipur RAJASTHAN 302022 India |
| Phone |
7405224060 |
| Fax |
|
| Email |
drayushgupta05@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Isha Bijarnia |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital, Jaipur |
| Address |
Mahatma Gandhi University of Medical Sciences and Technology
RIICO Institutional Area
Sitapura, Tonk Road,
Jaipur RAJASTHAN 302022 India |
| Phone |
8107324518 |
| Fax |
|
| Email |
Silayachisha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ayush Satishkumar Gupta |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital, Jaipur |
| Address |
Mahatma Gandhi University of Medical Sciences and Technology
RIICO Institutional Area
Sitapura, Tonk Road,
Jaipur RAJASTHAN 302022 India |
| Phone |
7405224060 |
| Fax |
|
| Email |
drayushgupta05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Hospital,
RIICO Institutional Area Sitapura, Tonk Road,
Jaipur, Rajasthan
India -n302022
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospita |
| Address |
RIICO Institutional Area Sitapura, Tonk Road,
Jaipur
RAJASTHAN
302022
India |
| 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 Ayush Satishkumar Gupta |
Mahatma Gandhi Medical college and Hospital |
Department of Anaesthesia,
Operation Theatre Complex Jaipur RAJASTHAN |
7405224060
drayushgupta05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, Mahatma Gandhi University of Medical Sciences and TechnologyJaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Isobaric Ropivacaine |
Group R Injection Ropivacaine 0.5% + Normal saline 0.5ml total volume of 2.5 ml will be using in intrathecal subarachnoid block. Intervention time will be less than 10 minutes and will observe patients hemodynamic parameters with pain score for up to 6 hours . |
| Comparator Agent |
Isobaric Ropivacaine + Fentanyl |
Group RF Injection Ropivacaine 0.5% + Injection Fentanyl 25mcg (0.5ml) total volume of 2.5 ml will be using in intrathecal subarachnoid block. Intervention time will be less than 10 minutes and will observe patients hemodynamic parameters with pain score for up to 6 hours . |
| Intervention |
SUBARCHNOID BLOCK |
INTRATHECAL DRUG ADMISNTRATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) ASA physical status I-II
2) Pregnant females scheduled for elective lower
segment C section surgeries |
|
| ExclusionCriteria |
| Details |
1)Patient with known psychiatric disorders,
2)Coagulopathy disorders
3)Infection at the site of block placement
4)Morbid obesity
5)Known Drug Allergie
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A comparassion intrathecal isobaric ropivacaine 0.5% with fentanyl v/s isobaric ropivacaine 0.5% in elective lower segment caesarean section surgeries to study duration of analgesia, |
at baseline ,at the time od induction of anaesthesia, after 1minutes of induction, 5minutes, 10minutes, 20 minutes, 30 minutes, 60minutes, 90 minutes, 120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of onset, time to achieve maximum level and duration of sensory block. Time of onset and duration of motor block.Postoperative pain assessment (VAS score) and total analgesic requirement in the first 24 hours in two groups.
To assess the side effects like nausea, vomiting, pruritis etc.
|
post-operatively 15 min, 1hr and 2 hr.
Time of onset sensory and motor
2 Segment regression sensory and motor.
|
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
05/08/2024 |
| 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="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Subarachnoid block is the most widely used regional anaesthetic procedure for lower abdominal and lower limb surgery including lower segment caesarean section (LSCS). It provide rapid onset, consistent sensory and motor blockade with adequate muscle relaxation and for all types of surgery below the level of umbilicus. Regional anaesthesia is safer than general anaesthesia and having advantage of the parturient being awake during the birth process. Intrathecal local anaesthetics (LA) alone are not enough for effective postoperative analgesia and higher dose of LA are also associated with haemodynamic instability, which can lead to unfavourable maternal and foetal outcome. So far, many adjuvants have been used to augment the analgesia produced by intrathecal LA and to reduce their adverse effects. It has been well documented that the combination of fentanyl and LA administered intrathecally has synergistic analgesic effects. Fentanyl is a lipophilic j-receptor opioid agonist. Intrathecally, fentanyl exerts its effect by combining with opioid receptors in the dorsal horn of spinal cord and may have a supra spinal spread and action.Hyperbaric bupivacaine (0.5%), an amide-type of local anaesthetic, has been the gold standard for intrathecal use in spinal anaesthesia for many years but also has been associated with severe hypotension, delayed recovery of motor block, and cardiotoxicity when used in large concentration or when accidentally administered intravascularly. The introduction of ropivacaine has a better margin of safety for local anaesthetic systemic toxicity. Various studies have evaluated the effectiveness of these newer drugs for spinal anaesthesia using hyperbaric and isobaric solutions with a reliable rate of success. The study includes 140 pregnant patients aged, ASA grade I, and II scheduled for surgeries under subarachnoid block enrolled in this study and allocated into two groups of 70 patients each. After shifted to the operating room, standard ASA monitoring was attached. Group RF- received intrathecally 0.5% Isobaric Ropivacaine (2.0 ml) +25mcg(0.5ml) fentanyl Group R- received intrathecally 0.5% Isobaric Ropivacaine (2.0 ml)+ 0.5ml NS 0.9Parameters noted were Hemodynamic parameters were recorded,immediately after administration of intrathecal drugs, 1 min, 3 min, 5 min, 10 min, 15 min, 30 min, 60 min, 90 min and 120 min after administration of intrathecal drugpost-operatively 15 min, 1hr and 2 hr. Time of onset, time to achieve maximum level and duration of sensory block noted &Time of onset and duration of motor block notedPostoperative pain was assessed by the VAS scale and total analgesic requirement in the first 24 hours in two groups.Rescue Analgesia IV Diclofeneac 75mg IV SoS.
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