| CTRI Number |
CTRI/2023/08/057037 [Registered on: 29/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare pain relief between a plane block on the abdomen versus a plane block over the middle of the spine in women who have undergone operations to deliver babies |
|
Scientific Title of Study
|
Comparing the post-operative analgesic effects of Erector spinae plane block and Transversus abdominis plane block in patients undergoing Elective Cesarean section - A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sruthi Shashikumar |
| Designation |
M.D.Anesthesia -Postgraduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anesthesia,Sri Venkateshwaraa Medical College Hospital and Research Centre,No.13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry.
Department of Anesthesia,Sri Venkateshwaraa Medical College Hospital and Research Centre,No.13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9446062643 |
| Fax |
|
| Email |
sruthi.skaygee93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhakrishnan |
| Designation |
Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anesthesia, Sri Venkateshwaraa Medical College Hospital and Research Centre,No.13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry.
Department of Anesthesia, Sri Venkateshwaraa Medical College Hospital and Research Centre,No.13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8825778958 |
| Fax |
|
| Email |
rkpuduvai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Radhakrishnan |
| Designation |
Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anesthesia,Sri Venkateshwaraa Medical College Hospital and Research Centre,No.13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry.
Department of Anesthesia,Sri Venkateshwaraa Medical College Hospital and Research Centre,No.13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8825778958 |
| Fax |
|
| Email |
rkpuduvai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswaraa Medical College Hospital and Research Centre, No 13-A, Pondy-Villupuram Main Road, Ariyur, Puducherry |
|
|
Primary Sponsor
|
| Name |
Dr Sruthi Shashikumar |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre,No.13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry |
| Type of Sponsor |
Other [PRINCIPAL INVESTIGATOR] |
|
|
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 Sruthi Shashikumar |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
Department of Anesthesiology,
ot complex, obstetrics division,room no.1,Pondy-Villupuram Main Road, Ariyur, Puducherry. Pondicherry PONDICHERRY
Pondicherry
PONDICHERRY |
9446062643
sruthi.skaygee93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
0.2 percentage Ropivacaine at 0.2 ml/kg bilaterally will be givenat T9 process level to patient in the erector spinae plane to find out pain relief after cesarean section. Total duration of procedure is 15min |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Transversus abdominis plane block |
0.2 percentage Ropivacaine at 0.2 ml/kg bilaterally will be given to patient in the transversus abdominis plane. to find out pain relief after cesarean section. Total duration of procedure is 15min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women aged between 18 to 40 years, undergoing elective lower segment cesarean section with normal singleton pregnancy more than 37 weeks gestational age.
American society of anaesthesiology class 2 |
|
| ExclusionCriteria |
| Details |
Localised infection. Systemic coagulopathy. Anatomical abnormalities. Allergy to study medication. Refusal to participate. Presence of major systemic illness. Body mass index more than 35 kilogram per square metre. |
|
|
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 |
| To compare duration of analgesia between transversus abdominis plane block and erector spinae plane block post elective cesarean section |
To compare duration of analgesia at 0 hr, 1hr ,2hr ,4hr ,6hr ,12hr ,24hr,36hr and 48hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare post operative visual analogue score for analgesia & number of rescue analgesia required |
To compare post operative analgesic pain scores & number of rescue analgesics required at 0 hr, 1hr ,2hr ,4hr ,6hr ,12hr ,24hr,36hr & 48hr |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1 |
|
Date of First Enrollment (India)
|
14/09/2023 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sruthi.skaygee93@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 15-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Post operative analgesia is a challenge in parturient women undergoing cesarean section. An ideal post operative analgesic technique must be effective in repressing maternal pain while having no side effects on the baby. While subarachnoid block is a commonly performed anaesthesia technique for cesarean sections, its actions are time limited. Most patients report moderate to severe intensity of pain affecting overall quality of life soon after the surgery. This study aims to compare two plane blocks that will be administered for post-operative analgesia to the patients and to understand which will act for a longer duration. |