FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/06/053959 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 14/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To study the effect of Epidural Volume Extension with saline in Combined Spinal Epidural in low dose spinal anaesthesia.  
Scientific Title of Study   To evaluate the effect of epidural volume extension with saline in combined spinal epidural for orthopaedic surgeries around hip using low dose intrathecal bupivacaine 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hemant Sharma 
Designation  Junior Resident 
Affiliation  Dr. Rajendra Prasad Government Medical College, Kangra at Tanda 
Address  Department of Anaesthesia, Dr. Rajendra Prasad Government Medical College Kangra at Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9728907735  
Fax    
Email  Hshsharma95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Versha Verma 
Designation  Associate Professor 
Affiliation  Dr. Rajendra Prasad Government Medical College, Kangra at Tanda 
Address  Department of Anaesthesia, Dr. Rajendra Prasad Government Medical College Kangra at Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418152286  
Fax    
Email  versha2u@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Hemant Sharma 
Designation  Junior Resident 
Affiliation  Dr. Rajendra Prasad Government Medical College, Kangra at Tanda 
Address  Department of Anaesthesia, Dr. Rajendra Prasad Government Medical College Kangra at Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9728907735  
Fax    
Email  Hshsharma95@gmail.com  
 
Source of Monetary or Material Support  
Dr Rajendra Prasad Government Medical College, Kangra at Tanda 
 
Primary Sponsor  
Name  Dr Rajendra Prasad Government Medical College Kangra 
Address  Department of Anaesthesiology, Dr RPGMC Kangra at Tanda, PIN code 176001  
Type of Sponsor  Government 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 
Dr Hemant Sharma  Dr Rajendra Prasad Government Medical College, Kangra at Tanda  Department of Anaesthesia, Dr. Rajendra Prasad Government Medical College Kangra at Tanda, Himachal Pradesh.
Kangra
HIMACHAL PRADESH 
9728907735

Hshsharma95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr RPGMC Kangra at Tanda, Himachal Pradesh, India-176001   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Epidural Volume extension.  The epidural volume extension (EVE) technique is a modification of CSE in which the onset and level of block obtained by subarachnoid block is increased by a small volume of saline or local anesthetic administered through the epidural catheter. The effect of EVE with saline in the enhancement of spinal block includes the volume effect in which the theca is compressed by injected epidural saline, resulting in squeezing of CSF and more cephalic spread of subarachnoid local anesthetic. Injected saline extends the block height by a mechanical volume effect (time‑dependent effect) and increases the regression time, thereby providing a longer duration of block with a smaller dose of hyperbaric bupivacaine given in subarachnoid space that may result in better hemodynamic stability and a early motor recovery.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. ASA class I-III
2. BMI between 18.5-29.9.  
 
ExclusionCriteria 
Details  1. Patient’s refusal to participate in the
study.
2. Patients with severe anatomical spinal
deformities.
3. Patients with bleeding disorders
4. Patients with local infection at the sites
where needle for CSE is to be inserted.
5. Patients with dysarrhythmias.
6. Patients allergic to study drug.
7. Patients on anticoagulants.
8. Failure of spinal/epidural anesthesia.
9. Anticipated duration of surgery more than
2 hour duration.
 
 
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 
Maximum level of sensory block attained  Every minute until the highest level is stabilised. 
 
Secondary Outcome  
Outcome  TimePoints 
Characteristics of motor & sensory block, hemodynamic changes, adverse events & additional analgesic requirements upto 24 hrs.   Hemodynamics measurement at 0, 3, 6, 9,12,15,18,21,24,27,30,35,40,45,50,55,60,65,70,75,80,85,90,95,100,105,110,115,120 minutes.
Number of rescue analgesia given in 24 hrs.
 
 
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 4 
Date of First Enrollment (India)   25/06/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet started 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Regional anesthesia has many advantages over general anesthesia, as it is a simple and effective block with small dose of local anesthetic. One of the most important advantage is the ability to provide extended postoperative pain control that is superior to that provided by systemic opioids alone.
Combined spinal epidural anaesthesia technique for providing pain relief in orthopaedic procedures has gained popularity. This technique is done as a one-time procedure where first the epidural space is located and intrathecal administration of either a combination of local anaesthetic and opioid or each component separately is done, followed by catheter insertion in the epidural space. It combines the advantages of rapid onset and the reliability of blockade obtained spinally along with the flexibility given by epidural catheter avoiding the disadvantages of either.
The combined spinal epidural anaesthesia technique (CSE), first reported in caesarean section in 1984, has recently gained popularity. Combined Spinal and Epidural Anaesthesia (CSE) offers advantages over the epidural or spinal anaesthesia alone. CSE has the reliability of subarachnoid block as well as the flexibility of epidural block. Combined spinal epidural involves the use of a lower dose of spinal anaesthetic and allows flexibility of epidural reinforcement when required. The use of epidural or spinal anaesthesia during major hip surgeries has been linked to reduced risk of perioperative complications such a deep vein thrombosis, less deterioration of cerebral and pulmonary functions in patients who are at a higher risk of complications,early ambulation, superior pain relief, and thus higher patient satisfaction.
The epidural volume extension (EVE) technique is a modification of CSE in which the onset and level of block obtained by subarachnoid block is increased by a small volume of saline or local anesthetic administered through the epidural catheter.[3] The effect of EVE with saline in the enhancement of spinal block includes the volume effect
in which the theca is compressed by injected epidural saline, resulting in squeezing of CSF and more cephalic spread of subarachnoid local anesthetic. Injected saline extends the block height by a mechanical volume effect (time-dependent effect) and increases the regression time, thereby providing a longer duration of block with a smaller dose of hyperbaric bupivacaine given in subarachnoid space that may result in better hemodynamic stability and an early motor recovery.[4]The majority of hip orthopaedic surgery patients are elderly and have multiple coexisting medical problems. Ensuring hemodynamic stability in these patients requires selection of appropriate techniques of regional anaesthesia, focussing on maintaining a safe and desirable level of blockade while limiting extensive sympathectomy.
We hypothesize that EVE would achieve a higher level of the sensory block using a smaller volume of local anesthetic which otherwise would achieve a lower level of the block without EVE and may also reduce the incidence of hemodynamic side effects.
This study is aimed to evaluate the efficacy of block provided by extending the epidural volume with two different doses of normal saline for orthopaedic surgeries around hip joint using a low dose intrathecal hyperbaric bupivacaine.

 
Close