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
|
|
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
|
|
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.
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