CTRI Number |
CTRI/2023/10/059119 [Registered on: 26/10/2023] Trial Registered Prospectively |
Last Modified On: |
25/10/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Assessment of pain relief between erector spinae block and local wound site infiltration in patients undergoing lumbar spinal surgeries |
Scientific Title of Study
|
The comparison of the efficacy between bilateral ultrasound guided erector spinae block versus incision site infiltration for duration of analgesia in lumbar spinal surgery using levobupivacaine: A prospective, randomized comparative 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 |
Dr Karthik G S |
Designation |
Professor |
Affiliation |
Rajarajeswari medical college and hospital |
Address |
Department of Anaesthesiology Rajarajeshwari medical college and hospital . Kambipura, Mysore road, Bangalore
Bangalore
KARNATAKA
560074 India
Bangalore KARNATAKA 560074 India |
Phone |
9538220515 |
Fax |
|
Email |
drgskarthik@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Karthik G S |
Designation |
Professor |
Affiliation |
Rajarajeswari medical college and hospital |
Address |
Department of Anaesthesiology Rajarajeshwari medical college and hospital . Kambipura, Mysore road, Bangalore
Bangalore
KARNATAKA
560074 India
Bangalore KARNATAKA 560074 India |
Phone |
9538220515 |
Fax |
|
Email |
drgskarthik@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Prajyot Bhurli |
Designation |
Post graduate |
Affiliation |
Rajarajeswari medical college and hospital |
Address |
Department of Anaesthesiology Rajarajeshwari medical college and hospital . Kambipura, Mysore road, Bangalore
Bangalore
KARNATAKA
560074 India
Bangalore KARNATAKA 560074 India |
Phone |
7022030837 |
Fax |
|
Email |
prajyot.bhurli2013@gmail.com |
|
Source of Monetary or Material Support
|
Rajarajeswari medical college and hospital Kambipura, Mysore road, Bangalore, Karnataka |
|
Primary Sponsor
|
Name |
Rajarajeswari medical college and hospital |
Address |
Kambipura, Mysore road, Bangalore, Karnataka, 560074 |
Type of Sponsor |
Research institution and hospital |
|
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 Karthik G S |
Rajarajeswari medical college and hospital |
Department of Anesthesiology , Rajarajeswari medical college and hospital , kambipura , mysore road , Bangalore karnataka Bangalore KARNATAKA |
9538220515
drgskarthik@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICAL COMMITTEE, RAJARAJESHWARI MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Erector spinae block |
ESPB will be performed in group A before extubation. At the end of surgery, under strict aseptic conditions, counting above from L4 vertebrae from the tuffiers line , L3 vertebrae will be identified. A curvilinear USG probe will be placed across the L2 spine and probe will be moved to identify L2 lateral process. 20 ml of 0.25% Inj levobupivacaine is injected below the fascia of erector spinae level using 23G Quincke needle by out of plane technique. Before this 2-3 ml of NS will be injected to make out the spread. |
Intervention |
Inj Levobupivacaine 0.25% in Erector spinae block and local wound site infiltration |
Inj Levobupivacaine 0.25% 20 ml will be injected in two separate groups to compare their efficacy postoperatively in the first 24 hours till the need of first analgesia. 1.Inj Levobupivacaine 0.25% 20 ml in erector spinae muscle 2. Inj Levobupivacaine 0.25% 20 ml as a wound infiltration at the local surgical site. |
Comparator Agent |
Local wound site infiltration |
Wound site infiltration will be performed in group B before extubation. At the surgery , at the wound site , local infiltration with 20 ml of 0.25% levobupivacaine is injected. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
ASA grade 1 and 2 patients. Patients aged 20-65 yrs undergoing single level lumbar discectomy surgeries.
|
|
ExclusionCriteria |
Details |
Patient refusal
Patients with known hypersensitivity to local anaesthetics
Patient with bleeding disorder, uncontrolled Diabetes Mellitus, severe Renal & Liver Diseases
Patient with Epilepsy
Mentally unstable patients
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare & assess the analgesic efficacy postoperatively between Erector spinae block & local wound site infiltration. |
To compare & assess the analgesic efficacy postoperatively between Erector spinae block & local wound site infiltration in FIRST 24 hrs. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the need of rescue analgesia postoperatively between Erector spinae block & local wound site infiltration
Comparison of hemodynamic parameters. complications if any |
Post operative period for first 24 hrs |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
06/11/2023 |
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="0" Months="8" 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
|
Spine surgeries are a widely accepted treatment for patients with pathology in the spine. However, postoperative pain following these surgeries is one of the most common complications.In addition, spinal surgery is one of the most painful surgical procedures, creating a major challenge in pain management. This pain begins with an irritation or inflammatory reaction by surgical trauma of the afferent neuron in different back tissues such as ligaments, nerve root sleeves, intervertebral discs, dura, muscles, facet joint capsules and fascia. Erector spinae plane (ESP) block is an interfascial blockade, first described by Forero in 2016. The erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra and LA is distributed in the cranio-caudal fascial plane one dermatome a median of each 3.4 ml of injected volume.
Aim is to Compare The Efficacy Of Ultrasound Guided Erector spinae block Vs wound infiltration For Post Operative Analgesia In Lumbar spine surgery using levobupivacaine.
Method of collection of data.
After obtaining institutional ethical committee clearance, a comparative study will be carried in Rajarajeshwari Medical college and Hospital in Department of Anaesthesia. The purpose, the procedure and the risks involved with the study will be explained to the patient and an informed consent will be taken.
50 patients of ASA 1 and ASA 2 aged between 20 and 65 years scheduled for elective single level lumbar discectomy surgeries will be selected. All patients will be subjected to detailed preanesthetic evaluation. Routine and specific investigations will be done as per patients clinical evaluation along with optimising with regular medication if required. Patients will be randomly allocated into two groups of 25 each by single blinded open envelope technique.
Group A – Patients will receive 25 ml of 0.25% Levobupivacaine at the level of L2. Group B – Patients will receive 25 ml of 0.25% Levobupivacaine over the the surgical wound site.
All the patients will be reviewed and explained about the procedure. Patients will be kept nil by oral for 6 hours and will be given T.Pantoprazole 40mg T. Alpralozolam. On arrival of the patient to the operation theatre, monitors will be connected and base line respiratory rate, pulse rate, non-invasive blood pressure, SPO2 and ECG recorded. Intravenous line of 18G shall be secured and intravenous fluids will be started as per requirement. Patient in supine position with adequate preoxygenation and premedication with Inj Midazolam 0.01mg/kg and Inj Glycopyrolate 0.2mg will be induced with Inj Fentanyl 1-2mcg/kg, Inj Propofol 2mg/kg and Inj. Vecuronium 0.1mg/kg. After obtaining adequate muscle relaxation, laryngoscopy will be done and intubated with endotracheal tube. Bilateral airway entry is confirmed and secured appropriately. Patient is changed to prone position and hemodynamic parameters will be monitored throughout the procedure at regular intervals.
At the end of surgery, under strict aseptic conditions, counting above from L4 vertebrae from the tuffiers line , L3 vertebrae will be identified. A curvilinear USG probe will be placed across the L2 spine and probe will be moved to identify L2 lateral process. 20 ml of 0.25% levobupivacaine is injected below the fascia of erector spinae level using 23G Quincke needle by out of plane technique. Before this 2-3 ml of NS will be injected to make out the spread. In the other group, local wound site infiltration is done using 20 ml of 0.25% levobupivacaine.
The patient is changed to supine position and extubation will be done after a reversal of residual neuromuscular block with neostigmine (0.05 mg/kg) and glycopyrrolate (0.01 mg/kg) at the end of the surgery. Patients will be transferred to post anesthesia care unit to monitor hemodynamic parameters, postoperative pain, sedation, nausea and vomiting at 0,1,2,4,6,8,12,16,20,24hrs. Patients will be evaluated pain postoperatively for the duration of analgesia and pain will be assessed using a standard 10 cm linear VAS. Pain assessment will be done 20 minutes after extubation which will be considered as zero time. Total duration of analgesia will be taken from zero time till the first rescue analgesic requirement. When VAS score is more than or equal to 4, Inj.Paracetamol 1g will be given as rescue analgesia. Total number of doses of Inj Paracetamol 1g given in 24 hours will be noted. Patients will be left out of the study in case of block failures
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