| CTRI Number |
CTRI/2019/12/022513 [Registered on: 23/12/2019] Trial Registered Prospectively |
| Last Modified On: |
08/09/2022 |
| 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
|
To compare two variety modes of pain decreasing methods on well being in patients undergoing backbone operation. |
|
Scientific Title of Study
|
Epidural morphine and ketamine versus intravenous morphine and ketamine on postoperative quality of recovery(QoR) in patients undergoing transforaminal lumbar interbody fusion:A single blinded randomised 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 |
DrSailaja Karri |
| Designation |
Pg registrar in anaesthesiology |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
Department of anesthesiology
Christian medical college
Vellore
Employment Number:21771
Vellore TAMIL NADU 632004 India |
| Phone |
8074276504 |
| Fax |
|
| Email |
sailaja.sailuu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ramamani mariappan |
| Designation |
Professor |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
Department of neuroanaesthesia
Christian medical college
Vellore
Employment Number : 50916
Vellore TAMIL NADU 632004 India |
| Phone |
9443753184 |
| Fax |
|
| Email |
ramamani@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
DrRamamani mariappan |
| Designation |
Professor |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
Department of neuroanaesthesia
Christian medical college
Vellore
Employment Number : 50916
Vellore TAMIL NADU 632004 India |
| Phone |
9443753184 |
| Fax |
|
| Email |
ramamani@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Silver,Research and Ethics Committee
Institutional Review Board
Fluid Research Grant -Major research grant
Office of Research, I Floor,
Carman Block
Christian Medical College
vellore
Tamil Nadu
632002.
Tel :0416-2284294
Email: research@cmcvellore.ac.in |
|
|
Primary Sponsor
|
| Name |
Institutional Review Board |
| Address |
Institutional review Board
Christian medical college
Research Section office
Vellore
India |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sailaja Kari |
Christian Medical college |
Main Operation Theatre
Department of Anesthesia
Christian Medical College
Vellore -632004
Tamil Nadu. Vellore TAMIL NADU |
8074276504
sailaja.sailuu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Silver, Office of Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RCT |
Epidural Inj .Morphine 8 mg, Ketamine 60 mg will be diluted upto 50 ml in a CADD pump and will be delivered at 1 ml/hr for 48 hours. |
| Comparator Agent |
RCT |
PCA through CADD pump Morphine and Ketamine at the concentration ration of 1:1 .Patients will get 0.015ml /kg /bolus with the lock out period of 10 mins ( max upto 6 bolus dose /hour ) will be delivered for the IV group. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I and II
2.Patients undergoing Transforaminal Lumbar Interbody fusion.
3.Normal renal function. |
|
| ExclusionCriteria |
| Details |
1.ASA III and IV
2.BMI >30
3. Impaired renal function.
4.Intraoperative csf leak
5.Previous surgical procedures in lumbo sacral region
6.Patients with psychiatric illness.
7.Obstructive sleep apnoea. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Quality of recovery score between the two groups of patients using QoR 15 Score. |
Primary investigator will assess the Quality of recovery at the end of 48 hours after operation in the ward. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the analgesic efficacy of the two techniques using Numeric rating scale at movement.
2.Patient satisfaction score (0-10).
3.Time of ambulation
4.Length of hospital stay
5. Sedation score, respiratory rate,Ponv,pruritus
6.Time of receiving first rescue analgesia for breakthrough pain. |
1. In the post anesthesia care unit by recovery staff at intervals of half an hour till discharge from recovery room
.
2 Post operative ward -.Pain nurse and ward staff will asess at the arrival to post operative ward, at 2 hrs, 6 hrs,12 hrs,24 hrs,36 hrs,48 hrs.
3. Primary investigator will assess at end of 24 hrs and 48 hours after suggery.
|
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2019 |
| Date of Study Completion (India) |
10/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/11/2021 |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Planning to publish after completion of study.
Potential Authors in future
1. Dr.Sailaja Karri
2.Dr. Ramamani Mariappan
3.Dr.Krishna prabhu
4.Dr. Edmond Jonathan G
5.Dr.Karen ruby Lionel
6.Dr.Jayashhelan L
7.Dr.Ari G Chacko
8.Dr. Prasad Kanna
9.Dr. Mammen philip
10. Sr. Jermaiah Samuel. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Pain is an important factor affecting postoperative quality of recovery (QoR) after open transforaminal lumbar interbody fusion (TLIF) surgery. It not only delays discharge from hospital but also affects the patient’s physical and psychological recovery. Continuous administration of intravenous morphine with or without ketamine is routinely used to treat postoperative pain after major spine surgery at our institution. Continuous administration of I.V morphine at fixed rate can lead to either overdose or under dose. So we have decided to administer i.v morphine through patient control analgesia system, where patient can control their pain by themselves by administering morphine and ketamine using a pump. Epidural morphine has been shown to decrease postoperative pain and opioid consumption after spine surgery and when coupled with the simultaneous administration of Ketamine, a further decrease in the total opioid dose and side effects may be expected. In this study we wish to compare two routes of administration of these drugs for providing postoperative analgesia in patients undergoing open TLIF. Our hypothesis is that the epidural administration of morphine and ketamine would be superior to intravenous administration of these drugs. Forty ASA 1 and 2 patients will be randomized into two groups after obtaining informed consent. Patients with age > 70 years, ASA 3 and 4, BMI > 30, Obstructive sleep apnoea, impaired renal function (serum creatinine > 1.4mg/dl), moderate to severe chronic obstructive lung disease, H/o previous surgical procedures in the lumbosacral region, H/o psychiatric illness all will be excluded. Group A will receive epidural morphine and ketamine (Inj. Morphine 8 mg, ketamine 60 mg diluted with normal saline, total volume made to 50 ml ,injected through the epidural catheter at 1 ml/hour, while patients in Group B will receive the same drugs intravenously at the concentration ratio of 1:1 via the CADD pump. Group B patients will get 0.015 ml/kg/bolus with the lockout period of 10 mins (max up to 6 bolus dose/hr) for 48 hours. The intraoperative anaesthetic techniques in the two groups will be standardised. Patients will be assessed at specified times after surgery with regard to verbal rating scale (VRS) for pain and for the side effects like postoperative nausea and vomiting, sedation, respiratory depression, hallucination. Patient satisfaction score and quality of recovery score will be assessed at the end of 48 hours |