| CTRI Number |
CTRI/2024/11/077361 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomised controlled single blinded study comparing traditional lumbar subarachnoid block with novel thoracic segmental subarachnoid block for Lower Segment cesarean section in Indian population in terms of perioperative outcomes |
|
Scientific Title of Study
|
Comparative study of traditional lumbar subarachnoid block vs novel thoracic subarachnoid block for cesarean section: A randomised single blinded 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 |
Damarla Haritha |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Medical College |
| Address |
Operation Theatre complex, second floor, Narayana General Hospital, Chintareddy Palem, Nellore
Nellore ANDHRA PRADESH 524003 India |
| Phone |
8096455970 |
| Fax |
|
| Email |
damarlaharitha007@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Damarla Haritha |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Medical College |
| Address |
Operation Theatre complex, second floor, Narayana General Hospital, Chintareddy Palem, Nellore
Nellore ANDHRA PRADESH 524003 India |
| Phone |
8096455970 |
| Fax |
|
| Email |
damarlaharitha007@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Damarla Haritha |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Medical College |
| Address |
Operation Theatre complex, second floor, Narayana General Hospital, Chintareddy Palem, Nellore
Nellore ANDHRA PRADESH 524003 India |
| Phone |
8096455970 |
| Fax |
|
| Email |
damarlaharitha007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Medical College, Chintareddypalem, Nellore, Andhra Pradesh. PIN: 524003 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [] |
|
|
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 Damarla Haritha |
Narayana Medical College |
2nd floor. Operation Theatre complex, Narayana General Hospital Nellore ANDHRA PRADESH |
8096455970
damarlaharitha007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute 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 |
Lumbar subarachnoid block |
Under all aseptic precautions in sitting position, hyperbaric bupivacaine 0.5% (10mg) with preservative free buprenorphine 60mcg (total volume 2.2ml) is administered at L3-L4 or L4-L5 levels into the subarachnoid space after confirmation of free flow of cerebrospinal fluid |
| Intervention |
Thoracic segmental subarachnoid block |
Under all aseptic precautions in sitting position hyperbaric bupivacaine 0.5% (6mg) with preservative free buprenorphine 60mcg (Total volume 1.6ml) is administered at T9-T10 or T10-T11 levels into the subarachnoid space after confirmation of free flow of cerebrospinal fluid |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Age more than 18 years
2. ASAPS 2 and 3
3. Elective cases posted for Cesarean section under neuraxial anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Refuse to consent
2. BMI more than 35 kg/m2
3. ASAPS more than 3
4. Contraindication to neuraxial block |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the duration of motor blockade through
1. Ability of the patient to slide out of the table with flexion at the hip by the end of the surgery
2. Time to be able to sit from the side of the bed with legs dangling
3. Time to walk with support
|
Throughout PACU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the incidence of following perioperative outcomes:
1. Incidence of nausea, vomiting, and shivering.
2. Hemodynamic stability
3. Requirement of sedation
4. Abdominal muscle relaxation
5. Postoperative urinary retention
6. Incidence of PDPH, neurological complications
|
Till the time of hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Cesarean delivery is one of the most common surgeries performed globally. Neuraxial anaesthesia is preferable to general anaesthesia for cesarean delivery as it is associated with less maternal and neonatal morbidity and mortality. Traditionally, spinal anaesthesia is administered in the lumbar region to avoid spinal cord injury. Recent MRI studies indicate a more substantial depth of the posterior subarachnoid space in the thoracic spinal cord and therefore showed no neurological sequelae at the thoracic level, and the incidence of paresthesia was similar to that seen at the lumbar level. The total amount of CSF in the thoracic segment is less when compared to the lumbar and cervical segments, causing easy blockade of roots and a reduction in the dose of the drug required, along with improved muscle relaxation. During lumbar spinal anaesthesia, the sympathetic blockade extends to the lower limbs resulting in vasodilation of the blood vessels and reduction in preload. During thoracic spinal anaesthesia, the sympathetic block is restricted to fewer dermatomes with minimal involvement of the lower limbs, therefore, a smaller reduction in preload and blood pressure is seen. Thoracic segmental spinal anaesthesia has been gaining popularity in recent times and has been successfully performed for abdominal cancer surgeries, breast surgeries, laparoscopic cholecystectomies, and nephrolithotomies. In pregnant females posted for cesarean section, thoracic spinal anaesthesia helps in early mobilisation postoperatively, which meets the goals of enhanced recovery after surgery (ERAS). It also helps with the early initiation of breastfeeding, ensuring that the infant receives colostrum while facilitating the emotional bonding between the mother and the baby. We are thus conducting this study to explore the effectiveness of performing thoracic segmental spinal anaesthesia in patients posted for elective cesarean surgery under neuraxial blockade |