CTRI Number |
CTRI/2019/05/018870 [Registered on: 01/05/2019] Trial Registered Prospectively |
Last Modified On: |
14/03/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
Clinical usefulness of erector spinae plane block for lumbar single level spine surgery |
Scientific Title of Study
|
Clinical efficacy of ultrasound guided bilateral erector spinae plane block for single level lumbar fusion surgery. A prospective, randomized, double blinded, case control study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Not registered anywhere else |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Vipin Kumar Goel |
Designation |
Junior consultant |
Affiliation |
Ganga hospitals and medical centre |
Address |
Dept of Anaesthesiology, Ganga hospitals and medical centre, 313, mettupalayam road, Saibaba colony.
Coimbatore TAMIL NADU 641043 India |
Phone |
|
Fax |
|
Email |
drvipingoel@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vipin Kumar Goel |
Designation |
Junior consultant |
Affiliation |
Ganga hospitals and medical centre |
Address |
Dept of Anaesthesiology, Ganga hospitals and medical centre, 313, mettupalayam road, Saibaba colony.
Coimbatore TAMIL NADU 641043 India |
Phone |
|
Fax |
|
Email |
drvipingoel@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vipin Kumar Goel |
Designation |
Junior consultant |
Affiliation |
Ganga hospitals and medical centre |
Address |
Dept of Anaesthesiology, Ganga hospitals and medical centre, 313, mettupalayam road, Saibaba colony.
Coimbatore TAMIL NADU 641043 India |
Phone |
|
Fax |
|
Email |
drvipingoel@gmail.com |
|
Source of Monetary or Material Support
|
Hospital Administration (Ganga Medical centre & Private
hopsital Ltd)
313, mettupalayam road,Coimbatore-641043 |
|
Primary Sponsor
|
Name |
Hospital administration |
Address |
313, mettupalayam road,
Sai baba colony, Coimbatore-641043 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Madhanmohan C |
Fifth floor orthopedic main operation theatre |
Fifth floor orthopedic main operation theatre, Ganga medical centre and hospitals, Pvt. Ltd, 313, mettupalayam road, Saibaba colony Coimbatore TAMIL NADU |
09166774973
maddymbbs07@gmail.com |
Dr Vipin Kumar Goel |
Orthopedic Operation theatre |
Fifth floor orthopedic main operation theatre,
Ganga Medical centre & Hospitals Private limited Coimbatore TAMIL NADU |
9443369715
drvipingoel@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review board (IRB) GangaMedical centre & Hospitals Private Limited |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M488||Other specified spondylopathies, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIl |
No specific intervention will be done in this group. All anaesthetic management will remain the same except that this group will not receive the erector spinae block |
Intervention |
Ultrasound guided bilateral erector spinae block for single level Lumbar fusion surgery |
After general anesthesia is administered, patient will put on prone position. Then ultrasound will be used to identify the appropriate vertebral level (2 level above the vertebrae to be operated) and a high frequency linear-array ultrasound transducer (SonoSite, Bothell, WA, USA) covered in a sterile sleeve will be placed in a longitudinal parasagittal orientation 3 to 4 cm lateral to the midline to identify the tip of the transverse process. A 23G 90 mm Quincke’s spinal needle will be used in out of plane/ in plane technique to contact the transverse process. Correct needle tip position will be confirmed by hydro dissection by 1 ml of Saline solution followed by injection of 20 ml of Inj. Anawin 0.25% with 4 mg of dexamethasone. Correct drug placement will be confirmed by linear spread of the local anaesthetic drug separating the erector spinae muscle from the transverse processes. |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
• Patients requiring single level fusion surgery at lumbar spine (L1 to L5) for degenerative and lytic changes
• ASA I and II patients
|
|
ExclusionCriteria |
Details |
1. Patient refusal
2. bleeding disorder
3. Local infection.
4. Patient who were on chronic drug therapy.
5. Adjacent segment disease requiring surgeries
6. Inflammatory or infective etiology
7. Foreign nationals
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Requirement of opioid analgesia in the perioperative period |
At end of 48 hours from start of surgery |
|
Secondary Outcome
|
Outcome |
TimePoints |
Duration of analgesia |
Till when rescue analgesia is given |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "103"
Final Enrollment numbers achieved (India)="103" |
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
|
01/05/2019 |
Date of Study Completion (India) |
31/05/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="5" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Patients undergoing spine surgeries will have severe
perioperative pain which leads to morbidity and demands adequate analgesia. Multimodal analgesia involving NSAIDS, intravenous
paracetamol and steroids remains the mainstay for treating the pain in these
patients. In spite of the adequate usage of the above drugs most of the patient
might require opioids in the immediate postoperative period due to severity of
pain. Regional anaesthesia in these cases is administered by giving the local
anaesthetic in the epidural space or giving opioids epidurally or
intrathecally, though they are rarely practised. Erector spinae plane (ESP)
block described in 2016 as a novel regional anesthetic technique for acute and
chronic thoracic pain by Forerro et al [1]. It has also been used
for postoperative analgesia for breast surgery [2] and abdominal
surgery [3]. With the advances in usage of ultrasound for regional
anaesthesia, the performance of plane blocks have become much easier and more
reliable. The erector spinae plane block is a myofascial plane block where the
local anaesthetics are deposited in the plane between the erector spinae muscle
and the transverse process of the vertebrae. The local anaesthetic thereby
blocks the dorsal rami of the spinal nerves mainly and also ventral rami. We
are studying the efficacy of ultrasound guided ESP block for perioperative analgesia on
patients undergoing single level lumbar spine fusion surgery with control group. |