| CTRI Number |
CTRI/2022/04/042221 [Registered on: 27/04/2022] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of pain relieving efficacy and time duration of errector spinae block with general anaesthesia and multiple drugs analgesia with general anaesthesia in spine surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy and duration of erector spinae block with general anaesthesia and multimodal analgesia with general anaesthesia in spine surgeries- a prospective, randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayush Gupta |
| Designation |
Resident |
| Affiliation |
Mahatma Gandhi Hospital and Medical College |
| Address |
OT Complex 2nd floor, Department of Anaesthesia,
Mahatma Gandhi Medical College And Hospital, Sitapura industrial area, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
8009420240 |
| Fax |
|
| Email |
ayushgupta20061992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Hospital and Medical College |
| Address |
OT Complex 2nd floor, Department of Anaesthesia,
Mahatma Gandhi Medical College And Hospital, Sitapura industrial area, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7597053927 |
| Fax |
|
| Email |
drsunitakhs@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Mathur |
| Designation |
Professor And HOD of Neuroanaesthesia |
| Affiliation |
Mahatma Gandhi Hospital and Medical College |
| Address |
OT Complex 2nd floor, Department of Anaesthesia,
Mahatma Gandhi Medical College And Hospital, Sitapura industrial area, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302006
India |
| Phone |
9829191038 |
| Fax |
|
| Email |
drvijaymathur9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma gandhi medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Hospital and Medical College |
| Address |
Department of Anaesthesia and Critical Care, Mahatma Gandhi Hospital,Sitapura, Jaipur ,Rajasthan |
| 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 |
| Dr Ayush Gupta |
Mahatma Gandhi Hospital and Medical College |
Department of Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura, Jaipur ,Rajasthan
Jaipur
RAJASTHAN |
8009420240
ayushgupta20061992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multiple analgesic medications(paracetamol,dexamethasone,magnesium sulphate) utilized in a synergistic manner to control pain while minimizing side-effects of individual drugs due to decreased doses. This includes pre-operative patient education, intra-operative pain management and post-operative pain protocols. |
Subjects are given medications perioperatively that implement a multi-modal approach to managing pain.
|
| Intervention |
patients will receive bilateral ultrasound guided erector spinae block before the spine surgery starts.(20ml of bupivacaine 0.25%) after receiving general anesthesia |
The patient will be placed in the prone position. A high-frequency linear probe or a curved array probe, depending on the BMI of the patient, will be placed in longitudinal alignment, 2-3cm lateral to the vertebral column. The transverse processes of the vertebrae at the level of surgery, the erector spinae muscle, and the psoas muscle will be identified. A 5- or 8-cm 22-G ultrasound needle will be inserted with an in-plane technique in a cephalad-to-caudal direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20ml of bupivacaine 0.25% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fulfilling criteria of American Society of Anesthesiology (ASA) of Classes I/ II.
2.Patient aged 18-65 years of both sexes.
3.Patients undergoing elective spine surgeries under general anesthesia.
4.Patients giving consent willingly
|
|
| ExclusionCriteria |
| Details |
1.Patient with ASA CLASS III, IV & V
2.Refusal of patient
3.Patient with difficult surgical anatomy
4.Local infection at the site of injection
5.History of allergy to opioid or local anesthesia
6.Inability to comprehend or participate in pain scoring system.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| perioperative by haemodynamic variability like BP,HR,SpO2,mean BP and postoperatively by visual analog scale(VAS), if VAS is more than 3 the patient will receive a rescue dose of 2mg/kg of tramadol |
1. haemodynamic monitoring baseline
2.at the time of induction
3.at the time of block/multimodal analgesia
4.15min affter block/mma
then every 15min till extubation
5. post extubation
6. post extubation vitals and VAS score monitoring every 5min. if more than 3 VAS score then injection tramadol 2mg//kg/bw. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mean blood pressure, heart rate, patient satisfaction |
perioperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2022 |
| Date of Study Completion (India) |
30/07/2022 |
| 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)
|
Eur. Chem. Bull. 2023, 12(Special Issue 10), 2987 - 2992 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
post operative pain management is an essential component of anaesthetic management of surgical patient. it ensure patient comfort, fewer cardiac and respiratory complication, early mobilization and hence less chances of deep vein thrombosis. the goal of postoperative pain management is to relieve pain while keeping side effects to a minimum. Even after years of advances, the mainstay of pain therapy is still the opioids. while they are very effective analgesics, opioid also carry with them many undesirable side effects: sedation, respiratory depression, nausea and vomiting, hypotension and and bradycardia, pruritis and inhibition of bowel function. to avoid these newer modalities of pain management are being evaluated. management of acute pain following surgery using multimodal approach is recommended by the American society of Anaesthesiologists whenever possible. In addition to opioids, drugs with differing mechanism of actions target pain pathways resulting in additive and/or synergistic effects. Some of these agents include alpha2 agonists, NMDA receptor antagonists, gabapentinoids, dexamethasone, NSAIDs, acetaminophen, and duloxetine, MgSo4 etc. In regional anaesthesia, errector spinae block for spine surgery is gaining popularity. however, there are few clinical studies on ESPB and its effectiveness and safety are controversial. In view of large number spine surgeries that are conducted in our hospital, we intend to compare efficacy of regional anaesthesia with multimodal analgesia using paracetamol,Mgso4 and dexamethasone to ensure better surgical comfort in patient undergoing spine surgery under general anaesthesia. |