| CTRI Number |
CTRI/2025/07/091116 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of anaesthetic injection over sacrum with epidural for pain relief in later stages labour |
|
Scientific Title of Study
|
Efficacy of combined sacral erector spinae plane block with epidural for labour analgesia during second stage of labour: A randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Sindhu Raghuveera |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 5011 Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
7893683588 |
| Fax |
|
| Email |
sindhuraghuveera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sana Yasmin Hussain |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 5011 Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
9769144164 |
| Fax |
|
| Email |
drhussainsana17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sana Yasmin Hussain |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 5011 Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
9769144164 |
| Fax |
|
| Email |
drhussainsana17@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of Medical Sciences, New Delhi, India 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical Sciences, New Delhi |
| Address |
AIIMS, Ansari Nagar, Delhi 110029 |
| 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 M Sindhu Raghuveera |
All India Institute of Medical Sciences,New Delhi |
1st floor, Labour room, maternity OT, Mother and Child Block, AIIMS, Ansari Nagar, New Delhi 110029
South
DELHI |
7893683588
sindhuraghuveera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS 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 |
| Comparator Agent |
Epidural analgesia |
An initial bolus of 10ml of 0.15% ropivacaine with 2mcg/ml fentanyl will be given (in 5ml aliquots) after negative aspiration, through the epidural catheter. It will be followed by infusion of 0.1% ropivacaine with 2mcg/ml fentanyl at 5-10 ml/hr.
Duration:1-2days
|
| Intervention |
Sacral Erector Spinae plane block along with epidural analgesia |
• Epidural analgesia will be started
• Once the patient is nearly 6-8cm dilated, she will be positioned in left lateral position
• A curvilinear 5-12Hz ultrasound probe will be placed on the lower lumbar region. It will be moved caudally to visualize the sacral crests
• At the S2 level, a 20G, 10 cm needle will be inserted cranio-caudally until contact with the median crest
• After negative aspiration for blood, ropivacaine 0.2% 20mL will be injected
Duration:1-2days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women, with gestational age of 36-42
weeks requesting pain relief in labour
2.Gravid, primiparous pregnant women planned for
normal delivery
3.Pregnant women aged between 18-42 years
4.Singleton births with vertex presentation
|
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent for the study
2. Allergic to local anesthetics
3. Hypertensive disorder of pregnancy, Cardiac abnormalities, neurological defects, systemic infections
4. History of drug/alcohol abuse
5. Obesity
6. Coagulopathy/on anticoagulants/abnormal bleeding profile
7. Infection in the area block
8. Emergency cases
9. Fetal anomalies, cephalopelvic disproportion
10. ASA III
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of breakthrough pain during second stage of labour. |
Time point at breakthrough pain during 2nd stage of labour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NRS scores for pain |
Baseline, every hourly in 1st stage of labour & every 30 min during 2nd stage of labour |
| Assessment of sensory level |
Baseline,every hourly in 1st stage of labour & every 30 min during 2nd stage of labour |
| Assessment of motor block |
Baseline,every hourly in 1st stage of labour & every 30 min during 2nd stage of labour |
| Need for additional pain relief & number of top-up boluses given |
From Baseline & whenever NRS score is more than 4 |
| Incidence of assisted vaginal birth/ conversion to LSCS |
at end of delivery |
| Patient satisfaction score |
2hrs after delivery |
| Pain during episiotomy & suturing |
Baseline at episiotomy |
| Duration of second stage of labour |
From 10 cm dilation to delivery of baby |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="1"
Months="6"
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
|
| Standard epidural analgesia may not provide adequate pain relief during the second stage of labour, particularly in the sacral and perineal regions. By evaluating the effectiveness of adding a sacral erector spinae plane (ESP) block to epidural analgesia, the study aims to determine whether this combination can offer more complete and targeted pain relief, enhance maternal satisfaction, and reduce the need for additional interventions—areas currently lacking robust evidence from randomized controlled trials. Therefore, the study aims to compare the analgesic efficacy of sacral erector spinae block for the management of second stage of labour pain in parturient patients. | |