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CTRI Number  CTRI/2024/05/066701 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 29/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A randomized prospective comparative study of incidence of post dural pucture backache(PDPB) following median and paramedian approach for administration of subarachnoid block in patients undergoing cesarian section  
Scientific Title of Study   A randomized prospective comparative study of incidence of post dural pucture backache(PDPB) following median and paramedian approach for administration of subarachnoid block in patients undergoing cesarian section  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sulekha  
Designation  Post MBBS DNB Trainee 
Affiliation  Tata Main Hospital  
Address  TMH Doctors hostel straight mile Road BH Area kadma Jamshedpur jharkhand Purbi singhbhum JHARKHAND 831001 India
Department of Anaesthetseia 2nd floor JGMH building jamshedpur Purbi singhbhum JHARKHAND 831001 India
Purbi Singhbhum
JHARKHAND
831001
India 
Phone  8979759165  
Fax    
Email  sulekhakohli268@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhanu Pratap Swain 
Designation  DA, DNB, Consultant  
Affiliation  Tata Main Hospital Jamshedpur Jharkhand  
Address  TMH Doctors hostel straight mile Road BH Area kadma Jamshedpur jharkhand Purbi singhbhum JHARKHAND 831001 India
Department of anaesthesiology 2nd floor JGMH building Tata Main hospital Bistupur Jamshedpur jharkhand Purbi singhbhum 831001 India
Purbi Singhbhum
JHARKHAND
831001
India 
Phone  9471519719  
Fax    
Email  bhanu.swain@tatasteel.com  
 
Details of Contact Person
Public Query  
Name  Dr Sulekha  
Designation  Post MBBS DNB Trainee 
Affiliation  Tata Main Hospital Jamshedpur Jharkhand  
Address  TMH Doctors hostel straight mile Road BH Area kadma Jamshedpur jharkhand Purbi singhbhum JHARKHAND 831001 India
Department of Anaesthetseia 2nd floor JGMH building Tata main Hospital JHARKHAND 831001 India
Purbi Singhbhum
JHARKHAND
831001
India 
Phone  8979759165  
Fax    
Email  sulekhakohli268@gmail.com  
 
Source of Monetary or Material Support  
Tata Main Hospital Jamshedpur jharkhand 831001 
 
Primary Sponsor  
Name  Tata Main Hospital  
Address  C Road west northern town Bistupur Jamshedpur Jharkhand 831001 
Type of Sponsor  Other [Industrial Hospital ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sulekha   Tata Main Hospital Jamshedpur jharkhand   2nd floor JGMH building Tata Main hospital C Road West Northern Town Bistupur Jamshedpur Jharkhand 831001 Purbi singhbhum JHARKHAND
Purbi Singhbhum
JHARKHAND 		 8979759165

sulekhakohli268@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Tata Main Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O745||Spinal and epidural anesthesia-induced headache during labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Median approach for spinal Anaesthetseia   In this approch the spinal needle is inserted below the lower edge of the spinous process of the selected upper vertebrae and passes through the supraspinous ligament, interspinous ligament, ligamentum flavum, and epidural space, piercing the dura mater  
Intervention  Paramedian approach for spinal Anaesthetseia   In this approach the spinal needle is inserted 1 cm lateral and 1 cm caudal to the caudal edge of the most superior spinous process in the sagittal plane. In this technique, the interspinous and supraspinous ligaments are not penetrated, and the ligamentum flavum is the first structure the needle encounters  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patient undergoing elective / emergency cesarean section

ASA grades |-||| 
 
ExclusionCriteria 
Details  Patients refusing to participate in the study
History of allergy to local anesthetics
Patients with coagulopathy or infection at the site of block
Patients with psychiatric illness or cognitive dysfunction
Patients with the history of previous back surgery, spondylolisthesis, and other lumbar disorders
Previous history of low back pain
Failure of spinal anesthesia  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of post-dural puncture backache (PDPB) in both groups in the first 3 months postoperatively  3 months postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Backache on Numerical Rating Scale (NRS) in both groups after 24 hours,1 week, 1 month, 2 months and 3 months postoperatively
The number of attempts required at subarachnoid block by either approach
Total requirement of additional analgesics for low backache in first 24 and 48 hours postoperatively (Morphine equivalents)
Compare the incidence of PDPH in the two groups in first 72 hours
 		 24 and 48 hours, 72 hours 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   11/05/2024 
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="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  


Background of study :

Single injection ol of subarachnoid block with local anaesthetic is the most common method for administration of Anaesthesia in patient posted for cesarean section, there are two common approaches to reach subarachnoid space
i, e midline and paramedian


Post-dural puncture backache (PDPB), which is characterized by continuous pain around the site of spinal puncture without any radicular pain, is one of the complications after spinal anesthesia3
Excessive stretching of spinal ligaments by paraspinal muscular relaxation and/or localized tissue trauma are proposed as pathophysiological factors for PDPB3
This pain can be of short duration lasting for 72 h to 1 week or can be persistent lasting beyond 3 months4

Research Question :  
 Is there any difference in the incidence of post-dural puncture backache (PDPB) after administration of subarachnoid block by either median or paramedian approach in cases of cesarean section?

Objective :
Primary Objective:
To determine the incidence of post-dural puncture backache (PDPB) in both groups in the first 3 months postoperatively
Secondary Objectives:
Backache on Numerical Rating Scale (NRS) in both groups after 24 hours,1 week, 1 month, 2 months and 3 months postoperatively
The number of attempts required at subarachnoid block by either approach 
Total requirement of additional analgesics for low backache in first 24 and 48 hours postoperatively (Morphine equivalents)
Compare the incidence of PDPH in the two groups in first 72 hours

Methodology:

210 patients undergoing elective or emergency cesarean section shall be randomly divided to receive subarachnoid block by either median (Group M, n=105) or paramedian (Group P, n=105) approach. 

Subarachnoid block shall be administered with 2.6 ml of 0.5% heavy Bupivacaine at L3-L4 interspace by a 27G Quincke needle in the sitting position in both groups for anesthesia.


Postoperatively, the patient shall be administered analgesics in the form of Inj. Paracetamol 1 gm IV 8 hourly and Inj. Diclofenac 75 mg IM 12 hourly for next 48 hours
Rescue analgesia shall be administered in the form of Inj. Tramadol 1mg/Kg intravenously
Twenty-four hours after operation, the patient shall be interviewed for low back pain
If patients had back pain, she shall be enquired about the level of low back pain, characteristics, aggravating factors, and degree of pain using a numeric rating scale (NRS).
We shall specifically evaluate back pain and not transient neurological symptoms (e.g. unilateral or bilateral pain or dysaesthesia with radiation into buttocks, thighs, calves or legs)
Severity of PDPB shall be categorized as either no backache (NRS 0), mild (NRS 1-3), moderate (NRS 4-7) or severe (NRS >7)
Patients shall be asked the same questions over the telephone after 7 days, 1 month, 2 months, and 3 months






  
 
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