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CTRI Number  CTRI/2024/10/075943 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of the pain releif achieved for cesaren /normal delivery when the epidural catheter is threaded upwards or downwards during insertion 
Scientific Title of Study   Effect of cephaloid vs. caudally threaded labor epidural catheter in achieving adequate sensory block for normal delivery/caesarean section-a randomized control study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadhana G 
Designation  Post graduate resident 
Affiliation  Amrita vishwa vidyapeetham 
Address  Dept of Anaesthesia, Amrita Institute of medical Sciences,Amrita vishwa vidyapeetham,kochi,kerala,india

Ernakulam
KERALA
682041
India 
Phone  08939430953  
Fax    
Email  sadhanaganesan23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sadhana G 
Designation  Post graduate resident 
Affiliation  Amrita vishwa vidyapeetham 
Address  Dept of Anaesthesia, Amrita Institute of medical Sciences,Amrita vishwa vidyapeetham,kochi,kerala,india

Ernakulam
KERALA
682041
India 
Phone  08939430953  
Fax    
Email  sadhanaganesan23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sadhana G 
Designation  Post graduate resident 
Affiliation  ,Amrita vishwa vidyapeetha 
Address  Dept of Anaesthesia, Amrita Institute of medical Sciences,Amrita vishwa vidyapeetham,kochi,kerala,india

Ernakulam
KERALA
682041
India 
Phone  08939430953  
Fax    
Email  sadhanaganesan23@gmail.com  
 
Source of Monetary or Material Support  
Amrita institute of Medical Sciences,Kochi,Kerala 682041,India 
 
Primary Sponsor  
Name  Amrita Institute of Medical Sciences 
Address  Edapally,Kochi,Kerala,India Pin:682041 
Type of Sponsor  Private medical college 
 
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 
DrNitu P V  Amrita institute of medical sciences  Labor room, Dept of Obstretic Anesthesia, Amrita institute of Medical sciences, Ernakulam
Ernakulam
KERALA 
09495962020

nituveesundeep@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amrita vishwa vidyapeetham,Institute of Medical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Caudally threaded catheter group   The catheter will be threaded caudal in CA group 
Intervention  Cephaloid threaded catheter group  The catheter will be threaded cephaloid in the CE group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Parturients between 18 and 40 years belonging to the American Society of Anesthesiologists (ASA) physical status Classes II and II1, with uncomplicated cephalic singleton pregnancy will be recruited.  
 
ExclusionCriteria 
Details  any contraindication for epidural placement like bleeding disorders, decreased platelet counts, sepsis, spinal column deformities, history of spine surgery and hypersensitivity to study drugs, parturients requiring emergency cesarean under general anesthesia.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of time taken to achieve sensory block up to T6 with cephaloid vs. caudally threaded labor epidural catheter for cesarean section  Till delivery of the baby 
 
Secondary Outcome  
Outcome  TimePoints 
To compare requirement of additional boluses,conversion to general anesthesia and incidence of complications.
 
Till delivery of the baby 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   01/12/2024 
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="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 - NO
Brief Summary
Modification(s)  

bor epidural analgesia is considered as the gold standard and is universally accepted. The pain during first stage of labor is due to uterine contraction and is referred to T10-L1 dermatomes. Pain during second stage of labor is due to stretching of perineum and referred to S2-4 nerve roots. Hence a block from T10 to S4 is required to provide adequate labor analgesia. If a cesarean section is required for these parturients, a block up to T6 is required. Despite widespread use, there are many uncertainties regarding the siting of epidural catheter. We hypothesized that cephaloid threaded labor epidural catheter will achieve sensory block up to T6 earlier than caudally threaded catheter whereas a caudally placed epidural will provide better analgesia during second stage of labor and episotomyThus we aimed to compare the effect of cephaloid vs. caudally threaded labour epidural catheter in achieving adequate sensory block in parturients.

Primary objective

Comparison of time taken to achieve sensory block up to T6 with cephaloid vs. caudally threaded labor epidural catheter for cesarean section

Secondary objectives are t o Comparison between  two groups, requirement of additional boluses  for achieving adequate block for cesarean section and conversion to general anesthesia for cesarean section

Materials and Methods

After the approval of the Institutional Ethical Committee, informed consent from parturients and CTRI registration, this prospective, double‑blinded, randomized study will be conducted. Parturients between 18 and 40 years belonging to the American Society of Anesthesiologists (ASA) physical status Classes II and II1, with uncomplicated cephalic singleton pregnancy will be recruited. Patients in active labor and desirous of having a labor epidural will be randomly assigned to two groups by computer generated random sequence of numbers. Blinding will be achieved by closed envelope technique.

Exclusion criteria include any contraindication for epidural placement like bleeding disorders, decreased platelet counts, sepsis, spinal column deformities, history of spine surgery and hypersensitivity to study drugs, parturients requiring emergency cesarean under general anesthesia.

Pain will be assessed using visual analog scale (VAS) before placement of the epidural catheter. Parturients will be randomized into group CA or CE group. The catheter will be threaded caudal in CA and cephaloid in group CE. After attaching monitors and starting an intravenous line, the patient will be placed in sitting position and under aseptic precautions an epidural catheter will be placed by consultant anesthesiologist at L3–L4 interspace  using Portex Epidural minipack system 2 (manufacturer: Smiths Medical, Czech Republic). The catheter will be threaded caudal in CA and cephaloid  in group CE parturients, 5cm into the epidural space. Test dose will be avoided in all parturients as per institutional protocol.

Accidental intrathecal or intravascular placement of catheter will be ruled out by aspiration of the multi‑orifice catheter. If there is an accidental intrathecal or intravascular placement, the catheter will be re‑sited, and the patient will be removed from the study. The intermittent epidural bolus dose of 20mL of 0.1% ropivacaine with 40 µg fentanyl will be used as per institutional protocol. Same dose regimen will be repeated as subsequent top‑up dose on patients demand for pain relief or when the pain score is >4.

A second anesthesiologist who will be blinded to the technique will assess the adequacy of analgesia after 20 minutes. Analgesia will be considered adequate if the pain score is <4. If adequate analgesia was not achieved even after 20 min, an additional 10 mL of 0.1% ropivacaine will be administered, and analgesia will be reassessed. If pain relief is inadequate, the epidural analgesia will considered as epidural failure, and parturient will be excluded from the study.

The presence of motor block in the lower extremities will be assessed using a Breen modified Bromage scale (Grade 1 as complete motor block to Grade 6 as no motor block). The pain score will be assessed 20 minutes after each bolus and the stage of labor will be noted. Pain score will be noted during episiotomy.

If these parturients are posted for cesarean section, they will be shifted to OR. Patient will be coloaded with 10mL/kg of Ringer lactate. Standard monitors will be connected and a test dose of 3mL of 2% lignocaine with adrenaline will be given to rule out intrathecal or intravascular migration of catheter. Following this 10mL 2% lignocaine with adrenaline + 50µg fentanyl +1mL sodium bicarbonate (total 12mL) will be given as aliquots. Time taken to achieve sensory block up to T6 will be noted. Additional doses required for achieving block up to T4 and conversion to general anesthesia due to failure to achieve adequate block will be noted.

 
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