| CTRI Number |
CTRI/2020/06/025565 [Registered on: 03/06/2020] Trial Registered Prospectively |
| Last Modified On: |
19/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Ropivacaine in the management of post-operative pain. |
|
Scientific Title of Study
|
Evaluation of optimal dose of epidural background infusion of Ropivacaine in the management of post-operative pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Agarwal |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
A-Block
Department of Anaesthesiology
SGPGIMS
Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904589 |
| Fax |
|
| Email |
anil_sgpgi@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anil Agarwal |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
A-Block
Department of Anaesthesiology
SGPGIMS
Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904589 |
| Fax |
|
| Email |
anil_sgpgi@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyotsana Jaiswal |
| Designation |
Student |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
A-Block
Department of Anaesthesiology
SGPGIMS
Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
6387435694 |
| Fax |
|
| Email |
jaiswal.jyotsana@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anil Agarwal |
| Address |
Professor
A Bkock
Department Of Anaesthesiology
SGPGIMS
Lucknow
|
| Type of Sponsor |
Other [Self] |
|
|
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 Anil Agarwal |
SGPGIMS,Lucknow |
Gastrosurgery OT,
OT Complex,
First Floor,
E block,
SGPGIMS
Lucknow Lucknow UTTAR PRADESH |
8004904589
anil_sgpgi@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, SGPGI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP WITH 25% OF EPIDURAL DOSE AS BACKGROUND INFUSION |
25% of the hourly epiduarl infusion dose will be in the form of background infusion (remaining 75% as demand dose) |
| Intervention |
GROUP WITH 50% OF EPIDURAL DOSE AS BACKGROUND INFUSION |
50% of the hourly epidural dose will be in the form of background infusion( remaining 50% as demand dose) |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either sex, ASA physical status I or II, who are scheduled for abdominal surgery under general anaesthesia and thoracic epidural analgesia, will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patient refusal and patients who are unable to understand the numerical rating scale for pain assessment, will be excluded in the study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative NRS score for dynamic pain(coughing) |
At 0(zero) hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours, 54 hours,60 hours, 66 hours, 72 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative nausea and vomiting (PONV), reqirement of rescue analgesia and rescue anti-emetic, hypotension, motor block, sedation, pruritis and respiratory depression. |
At 0(zero) hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours, 54 hours, 60 hours, 66 hours, 72 hours. |
|
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Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/06/2020 |
| 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
|
1.Hiroshi Komatsu, MD, Shigeru Matsumoto, MD, Hiromasa Mitsuhata, MD, Kyoko Abe, MD, and Sohachi Toriyabe,MD
2.Yamauchi M1, Asano M, Wantanabe M,Iwasaki S, Furuse S,Namiki A.
3.Department of Anaesthesia and Resuscitation , La Paz University Hospital , Madrid ,Spain
4.Kainzwaldener V, et al. Anaesthesist, 2013.
5.Krishan Yogesh Sawheney,Sandeep Kundra ,[…] and Ananjit Kaur
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Despite well-designed concept of perioperative pain management, recent studies have revealed that a large number of patients still suffer from unacceptable pain after surgery. So, for all types of surgery, it has been seen that Continuous Epidural Analgesia (CEA) provide superior analgesia over Patient Controlled Epidural Analgesia (PCEA) for overall pain. However patients receiving CEA had significantly higher incidence of nausea-vomiting and motor block. So, presently the efficacy of Patient Controllrd Epidural Analgesia (PCEA) compared with Continuous Epidural Analgesia (CEA) is not clear. The addition of a continuous background infusion to PCEA following gastrectomy resulted in better dynamic pain scores. So,we designed a prospective, randomised study to evaluate the optimal dose of epidural proportion of epidural demand dose and background infusion in the management of post-operative pain in patients undergoing abdominal sugery.
Patients who met the inclusion criteria during the pre-anaesthetic check up will be randomly assigned into two equal groups of 40 each with the help of a computer generated table of random numbers; each group will receive intra operative epidural catheter placement followed by administration of epidural bolus of (0.1% Ropivacaine + 1mcg/ml Fentanyl combination) and the volume of the bolus shall be 0.1 ml/kg, prior to commencement of surgery; which would be followed by epidural infusion of the same combination @ 0.1ml/kg/hr. In the post - operative period all the patients will receive epidural infusion of the same combinaton @ 0.2ml/kg. The patients will be randomized into one of the following groups: Group 1: 50% of the hourly epidural dose will be in the form of background infusion (remaining 50% as demand dose). Group 2: 25% of the hourly epidural infusion dose will be in the form of background infusion (remaining 75% as demand dose). The proportion of background and continuous infusion will be as per the group allocation. Bolus dose will be 2ml and lock out time interval will be 10 min. Maximum number of boluses will depend upon the total amount of the drug to be administered as bolus depending upon group allocation. An 18G thoracic epidural catheter would be placed at T8-9 or T9-10 intervertebral space in the operation theatre by an anaesthesiology resident not otherwise involved in the study; the epidural infusion will be started after induction of anaesthesia; standard anaesthesia technique will be used in all patients. Patient’s induction will be done by fentanyl 2-3 mg kg-1 and propofol 1.5-2.5 mg kg-1; orotracheal intubation will be facilitated by vecuronium 0.1 mg kg-1. Anaesthesia will be maintained with propofol, sevoflurane and oxygen air mixture. Hypotension was treated by infusion of isotonic sodium chloride or mephentramine 5 mg intravenously in incremental doses when systolic blood pressure was below 90 mm Hg. At the end of surgery residual neuromuscular paralysis would be antagonized with neostigmine 0.04 mg.kg-1 and glycopyrrolate 0.01 mg.kg1. Following satisfactory recovery, the patients will be extubated and shifted to the post-anaesthesia care unit. |