| CTRI Number |
CTRI/2019/06/019630 [Registered on: 11/06/2019] Trial Registered Prospectively |
| Last Modified On: |
10/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In lower spine surgery-comparing the pain relief duration with erector spinae plane block and single shot epidural techniques |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy of the Erector Spinae Plane Block with the Single Shot Epidural Analgesia in Patients Undergoing Lumbosacral Spine Surgery - A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramya |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical Care
2nd Floor Institute Block
Jipmer Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9531833300 |
| Fax |
|
| Email |
dr.ramya.suneel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Adinarayanan |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical Care
2nd Floor Institute Block
Jipmer Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
944239762 |
| Fax |
|
| Email |
adinarayanans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Adinarayanan |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical Care
2nd Floor Institute Block
Jipmer Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
944239762 |
| Fax |
|
| Email |
adinarayanans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Dhanvantari Nagar Gorimedu Pondicherry 605006 |
| 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 Ramya |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Anesthesiology and Critical Care
2nd Floor Institute Block
Jipmer Puducherry 605006
Pondicherry
PONDICHERRY |
9531833300
dr.ramya.suneel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M489||Spondylopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block |
After giving General anesthesia by Institute protocol patient put on prone position following which under sterile precautions linear ultrasound probe (8-13hz)placed on the level where surgery has to be done and transverse process two levels above is identified and confirmed by injecting saline following which 20ml of 0.25% bupivacaine with 2mg of morphine is given on both the sides seperately(40ml total) |
| Comparator Agent |
Single Shot Epidural Analgesia |
After patient is shifted to operation theatre and attached to monitors put in left lateral position in awake state and under sterile precaution 18Gauge tuohy epidural needle will be inserted in the epidural space (loss of resistance technique) at two levels higher than the level at which surgery will be performed and 12 ml of 0.25% bupivacaine with 4mg morphine will be given in single shot following which General anesthesia will be given according to institution protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
Type of surgery(elective lumbosacral spine surgery) |
|
| ExclusionCriteria |
| Details |
patient refusal
patient with history of allergy to local anesthetics
patient with coagulopathies or on anticoagulants
infection at injection site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Analgesic Efficacy of the Erector Spinae Block with Single Shot Epidural Analgesia in Patients Undergoing Lumbosacral Spine Surgery by Comparing the Duration of Analgesia between both groups. |
Time at which the patient asks for Rescue Analgesia for the first time within 48 hours by assessing the
Numeric Rating Pain Scale NRS 1 to 3 is Mild NRS 4 to 7 is Moderate and NRS more than 7 is Severe pain respectively which is recorded at 4 8 12 16 20 24 and 48 hours respectively in Postoperative Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Compare
Hemodynamic Parameters and Surgical Pleth Index
Numeric rating pain scale
surgical stress response by measuring serum cortisol IL 6 and IL 10
Intraoperative requirement of fentanyl
|
Hemodynamic Parameters like Heart Rate Mean Arterial Pressure Spo2 Surgical Pleth Index will be measured every 10 minutes from the Time before Induction to the End of Surgery
Total Intraoperative Fentanyl Reuirement will be noted
serum cortisol and interleukins IL6 and IL10 measured pre induction at the most traumatic point of surgery and 24 hours postoperative period respectively
|
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
01/07/2019 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study involves two groups group 1 patients undergoing elective lumbosacral spine surgery will be given erector spinae plane block after receiving general anesthesia in prone position by ultrasound guidance, other group will receive single shot epidural analgesia by loss of resistance technique in awake state in left lateral position after which general anesthesia will be given under institute protocol. We are comparing the analgesic efficacy by noting and comparing duration of analgesia and the time at which patient asks for rescue analgesia and by assessing pain score using numeric rating score in the postoperative period upto 48 hours. |