CTRI Number |
CTRI/2021/07/034708 [Registered on: 09/07/2021] Trial Registered Prospectively |
Last Modified On: |
09/07/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To Compare the efficacy of bilateral erector spinae block between two groups in spine fusion surgeries |
Scientific Title of Study
|
Efficacy of bilateral erector spinae block in patients undergoing posterior spine fusion surgeries -a comparative randomized control trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Suresh kumar |
Designation |
Junior resident |
Affiliation |
pondicherry institute of medical sciences |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, KALAPET, PONDICHERRY.
Pondicherry PONDICHERRY 605014 India |
Phone |
8220123361 |
Fax |
|
Email |
murali71095@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Arish BT |
Designation |
Assistant professor |
Affiliation |
pondicherry institute of medical sciences |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, KALAPET, PONDICHERRY.
Pondicherry PONDICHERRY 605014 India |
Phone |
9791853400 |
Fax |
|
Email |
ajstyle.bt@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Arish BT |
Designation |
Assistant professor |
Affiliation |
pondicherry institute of medical sciences |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, KALAPET, PONDICHERRY.
Pondicherry PONDICHERRY 605014 India |
Phone |
9791853400 |
Fax |
|
Email |
ajstyle.bt@gmail.com |
|
Source of Monetary or Material Support
|
PONDICHERRY INSTITUTE OF MEDICAL SCIENCE
KALAPET
PUDUCHERRY |
|
Primary Sponsor
|
Name |
pondicherry institute of medical sciences |
Address |
pondicherry institute of medical sciences,pondicherry |
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 |
Suresh kumar |
Pondicherry institute of medical science |
department of anaesthesiology,
pims, kalapet, pomdicherry Pondicherry PONDICHERRY |
8220123361
murali71095@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
PIMS institute ethics committee(IEC) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M498||Spondylopathy in diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
bilateral erector spinae block |
Group B: patients will be receiving conventional general anaesthesia with bilateral ultrasound guided erector spinae block given with total volume of 40 ml 0.25 % bupivacaine drug. |
Comparator Agent |
control group |
Group A: patients will be receiving conventional general anaesthesia with total volume of 40 ml of normal saline (0.9% Nacl) block. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1)Age group of 18-65 yrs.
2)both genders
3)American society of anaesthesiologist: I /II
4)Patient undergoing primary open posterior spine fusion surgeries under general anaesthesia.
|
|
ExclusionCriteria |
Details |
1)patients BMI >35
2)History of Chronic opioid user
3)History of Patients with Coagulopathy
4)History of Patients with allergy to the study drug
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.To assess postoperative pain by using Visual analog score (VAS) for the first 24 hours between erector spinae plane block and conventional general anaesthesia groups in spine surgery patients. |
24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To compare the hemodynamic parameters between erector spinae plane block and conventional general anaesthesia groups in spine surgery patients.
2.To determine the time for first opioid analgesia requirement in the postoperative period till 24 hours.
3.To determine the amount of cumulative opioid consumption between the groups during intraoperative and postoperative period till 24 hours.
|
1.To compare the hemodynamic parameters between erector spinae plane block and conventional general anaesthesia groups in spine surgery patients.
2.To determine the time for first opioid analgesia requirement in the postoperative period till 24 hours.
3.To determine the amount of cumulative opioid consumption between the groups during intraoperative and postoperative period till 24 hours.
|
|
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
|
N/A |
Date of First Enrollment (India)
|
12/07/2021 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Spine surgeries cause excruciating pain in the postoperative period limiting the patient’s ability to ambulate. The pain following surgery is said to last as long as 3-4 days. In order to achieve an early recovery, adequate pain management in the perioperative is essential to avoid any untoward complications. Regional techniques offers the benefit of a better pain control, early recovery of bowel functions, lesser PONV and easier participation in physical therapies comparing systemic analgesics. In line with this, Erector spinae plane block has been in use since 2016 when Forero et al demonstrated its efficacy in mitigating thoracic neuropathic pain. Many research papers were published subsequently stating its varied applications in different surgeries like post thoracotomy pain syndrome, breast surgeries, chronic shoulder pain, ventral hernia repair, abdominal and hip surgeries Siam EM did a comparative study on 30 patients undergoing posterior spine fusion surgeries. The results of the study showed that ESP significantly reduced the stress response, decreased inhalational anaesthetic and also helped in achieving controlled hypotension. Similarly, bilateral erector spinae block was evaluated for postoperative analgesia in lumbar spine surgeries by Singh et al in 2019, were forty patients randomly assigned into two groups and observed all the 20 patients in the control group required additional morphine in the postoperative period when compared to only 9 patients in the ESP group. The pain scores were also higher in the control group compared to the study group. In the same year, the efficacy of ultrasound guided erector spinae block in 60 patients undergoing lumbar spinal decompression surgery as a postoperative analgesic was conducted by yayik. The results showed that the postoperative visual analog scale score was higher at rest and during active movement in the control group when compared to the study group. Also the time at which the first rescue analgesic required was significantly longer in the ESP group. In another study, zhang et al in 2020 found that patients who received preoperative erector spinae block and underwent open lumbar spine surgeries showed enhanced recovery as assessed by MOAA/S score. All these patients had an early ambulation and shorter hospital stay. Eskin et al in 2020 have shown that ultrasound guided erector spinae block for postoperative analgesia in lumbar spine surgeries clearly explains that postoperative pain which was assessed by VAS were constantly lower in study group when compared to control group and hence it results in lowering the first time of rescue analgesic in study group postoperatively for the first 24 hours. In 2019, breebaart conducted a study on efficacy of bilateral lumbar erector spinae block after posterior lumbar fusion surgery and concluded that ESP block is safer in muscle plane which concludes no risk of mechanical nerve injury, reduction in the opioid consumption in ESP block which results in faster recovery and early mobilization postoperatively. |