CTRI Number |
CTRI/2021/11/038059 [Registered on: 15/11/2021] Trial Registered Prospectively |
Last Modified On: |
27/02/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Usefulness of erector spinae blocks for spine surgeries |
Scientific Title of Study
|
Efficacy of bilateral erector spinae block for intraoperative and postoperative analgesia in lumbar decompression surgeries |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Priyanka G |
Designation |
Assistant professor |
Affiliation |
Rajrajeshwari medical college and hospital |
Address |
#202,Rajrajeshwari medical college and hospital,Mysore road, kambipura,Bangalore Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore Bangalore KARNATAKA 560074 India |
Phone |
7795439546 |
Fax |
|
Email |
drpriyanka2405@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Priyanka G |
Designation |
Assistant professor |
Affiliation |
Rajrajeshwari medical college and hospital |
Address |
Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore Bangalore KARNATAKA 560074 India |
Phone |
7795439546 |
Fax |
|
Email |
drpriyanka2405@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Priyanka G |
Designation |
Assistant professor |
Affiliation |
Rajrajeshwari medical college and hospital |
Address |
Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore Bangalore KARNATAKA 560074 India |
Phone |
7795439546 |
Fax |
|
Email |
drpriyanka2405@gmail.com |
|
Source of Monetary or Material Support
|
Rajrajeshwari medical college and hospital |
|
Primary Sponsor
|
Name |
Rajrajeshwari medical college and hospital |
Address |
Rajrajeshwari medical college and hospital #202,Mysore road, kambipura,Bangalore |
Type of Sponsor |
Private 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 |
Priyanka G |
Rajrajeshwari medical college and hospital |
#202,Mysore road,kengri satellite town, kambipura Bangalore KARNATAKA |
7795439546
drpriyanka2405@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Rajrajeshwari medical college and hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Erector spinae block |
Erector spinae block is block given using local anesthesia between Erector spinae muscle and transverse process of the spine in order to block dorsal and ventral rami nerves |
Comparator Agent |
Paracetamol iv 1g |
Paracetamol iv 1g is given just before the incision |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA 1 patients |
|
ExclusionCriteria |
Details |
Coagulation disorders
BMI <18 or >30
Patient with surgical site infections
Patients with unstable spine integrity like fracture or scoliosis
Hypertensive, cardiac and diabetic patients |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To study the efficacy of erector spinae block as an analgesia in lumbar decompression surgeries |
To study the duration of action of erector spinae block as analgesia in lumbar decompression surgeries |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study how much effectively erector spinae block reduces opiods, inhalation anesthetics and muscle requirements intraoperatively |
3 hrs |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/12/2021 |
Date of Study Completion (India) |
08/12/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Efficacy of ultrasound guided erector spinae plane block as analgesia both during intraoperative and postoperative in patient undergoing lumbar spinal decompression surgeries:A randomization controlled study |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Erector spinae plane (ESP) block is a regional anesthesia technique in which local anesthesia is injected deep to Erector spinae muscle and transverse process under ultrasound guidance. This block has been shown to provide good postoperative analgesics for thoracic, breast and spine surgeries .primarily, the anatomic location of the ESP block is thoracic level(89.9%), followed by lumbar (9.3%) and cervical (0.8%).ESP block is a paraspinal interfascial plane block targeting the ventral and dorsal branches rami of the spinal nerves. We conducted a study to determine whether erector spinae block is effective in providing intraoperative and postoperative analgesia in lumbar decompression surgeries.
· 50 patients who were randomly allocated into two group, group ESB (erector spinae block )and group MMA (multimodal analegsia).
· The study was done to know whether erector spinae block could reduce perioperative pain, the requirement of opioid and muscle relaxant consumption during the surgery and postoperative analgesia.
· Data analysis was done using SPSS software version 16. Anthropometric measurements and vitals were shown using mean and standard deviation. Independent t-test used to find the difference in between mean P value < 0.05 is taken as significant.
· Our study showed that there were significant changes in the hemodynamic parameters i.e. SBP, DBP, MAP and HR (P<0.0001) intraoperatively during the incision and first 10 min interval in MMA group compared to ESB group.
· There was increase in opioid and muscle relaxant consumption after incision, after first 10 mins after the incision but there was no significant difference in total consumption.
· The rescue analgesia requirement was highly significant at 4th, 8th, 12th hour after the procedure in control group compared to ESP group (figure 7). Patients in ESP group had rescue analgesia at around 15 -18 hour after the procedure. The analgesic duration of ESP block was approximately 18-20 hours.
· The limitation of our study we didn’t take in to account regarding inhalation agents consumption, hence we don’t know how it ESB can infer the depth of anaesthesia and whether ESB block has any effect on the blood loss during the surgery. Patients with multiple level disectomy surgery were not included in our study somehow further studies can be done either by inserting a catheter in erector spine plane to increase the efficacy of the block. The evaluation of chronic pain after surgery was not done in our study.
· So we conclude that bilateral US-ESPB single shot block seems to be a useful intervention for providing adequate pain management during both intraoperative and postoperative period for patients undergoing lumbar spine single or double level discectomy.
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