| CTRI Number |
CTRI/2019/05/019184 [Registered on: 16/05/2019] Trial Registered Prospectively |
| Last Modified On: |
15/05/2019 |
| 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
|
Erector spinae muscle plane block on both side of spine using ultrasound machine for postoperative pain control in patients undergoing laparoscopic gall bladder surgery. |
|
Scientific Title of Study
|
Efficacy of ultrasound guided bilateral erector spinae plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchi Verma |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9415590425 |
| Fax |
|
| Email |
ruchiv197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ruchi Verma |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9415590425 |
| Fax |
|
| Email |
ruchiv197@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi Verma |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9415590425 |
| Fax |
|
| Email |
ruchiv197@gmail.com |
|
|
Source of Monetary or Material Support
|
| No source of monetory support |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow |
| 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 |
| Ruchi Verma |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Operation Theatre Complex, Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH |
9415590425
ruchiv197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 107th Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block |
Bilateral Erector Spinae Plane Block with 20ml 0.375% Ropivacaine each side under ultrasound guidance will be given after induction of anaesthesia in lateral position.
|
| Comparator Agent |
Erector Spinae Plane Block |
Bilateral Erector Spinae Plane Block with 20ml Normal saline each side under ultrasound guidance will be given after induction of anaesthesia in lateral position. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients,
Undergoing elective laparoscopic cholecystectomy under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patients with contraindications for regional anesthesia, known allergy to local anesthetics, bleeding diathesis, use of anticoagulants or corticosteroids, psychiatric disorders.
|
|
|
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 |
| Postoperative pain using a visual analog scale (VAS) in both groups at rest and dynamic pain on coughing. |
0 (at arrival in postoperative ICU), 1, 6, 12, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative total fentanyl consumption |
At the end of surgery |
| Time to ambulation of patient |
At 6hrs, 12hrs, 18hrs or 24 hours.
|
| Total need for rescue analgesic in postoperative period |
24 hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
31/05/2019 |
| 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="0"
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
|
Pain is the dominating complaint and the primary reason for prolonged convalescence after laparoscopic cholecystectomy1. It has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g. Post laparoscopic cholecystectomy syndrome)2. Erector spinae plane block is a novel thoracic myofascial plane block that was reported first in 2016.3 It is a simpler and safer alternative to thoracic paravertebral and epidural blockade because the sonographic target is easily visualized and the site of injection is distant to the neuraxis and any major vascular structures and provides more extensive cranio-caudal spread with a single injection without major complications4
Objective : To study and compare the analgesic efficacy of single shot bilateral erector spinae plane block in patients undergoing laparoscopic cholecystectomy.
DESIGN : Double blind , prospective, randomized controlled study
Methodology : A blinded anaesthetist 1 will explain about ESP block to patient and takes I/W consent in preoperative period and he will also collect the data later on. On day of surgery anaesthetist 2 will prepare 2 syringes of 20ml 0.375% ropivacaine or normal saline as per computer generated random table and assign a number and accordingly group (1/2) to the patient. A blinded anaesthetist 3 will give bilateral ESP block with 20 ml of drug each side under USG guidance after induction of anaesthesia. Anaesthetist 1 will manage case as per protocol with 2mcg/kg fentanyl at induction, 1mcg/kg at port insertion. Inj. Paracetamol 1gm iv pre-emptively Fentanyl repeated after 1 hour henceforth 1mcg/kg if needed Inj. Paracetamol 1 gm iv will be continued 8th hourly. Rescue analgesic in postoperative period (when the VAS > 4) : Inj. Diclofenac 75mg iv References : - Bisgaard T, Klarskov B, Rosenberg J, Kehlet H: Factors determining convalescence after uncomplicated laparoscopic cholecystectomy. Arch Surg 2001; 136:917–21
- Bisgaard T, Rosenberg J, Kehlet H: From acute to chronic pain after laparoscopic cholecystectomy: A prospective follow-up analysis. Scand J Gastroenterol 2005; 40:1358–64
- Forero M, Adhikary SD, Lopez H, et al. The erector spinae plane block: A novel analgesic technique in thoracic neuropathic pain. Reg Anesth Pain Med 2016;41:621–7
- Forero M, Rajarathinam M, Adhikary S, et al. Continuous erector spinae plane block for rescue analgesia in thoracotomy after epidural failure: A case report. A A Case Rep 2017;8:254–6
|