CTRI Number |
CTRI/2023/01/049068 [Registered on: 17/01/2023] Trial Registered Prospectively |
Last Modified On: |
26/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
comparison of intrathecal morphine versus Erector spinae plane block for postoperative pain control in patients with Kidney Disease undergoing kidney Transplantation |
Scientific Title of Study
|
A clinical comparison of intrathecal morphine versus Erector spinae plane block for postoperative pain control in patients with End Stage Kidney Disease undergoing kidney Transplantation |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
saurabh mittal |
Designation |
DM Resident |
Affiliation |
MAHATMA GANDHI HOSPITAL |
Address |
dept. of organ transplant anaesthesia and critical care
Jaipur RAJASTHAN 302022 India |
Phone |
|
Fax |
|
Email |
saurabh.mittal013@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vipin kumar goyal |
Designation |
Prof. and H.O.D |
Affiliation |
mahatma gandhi hospital |
Address |
dept. of organ transplant anaesthesia and critical care
Jaipur RAJASTHAN 302022 India |
Phone |
|
Fax |
|
Email |
dr.vipin28@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vipin kumar goyal |
Designation |
Prof. and H.O.D |
Affiliation |
mahatma gandhi hospital |
Address |
dept. of organ transplant anaesthesia and critical care
RAJASTHAN 302022 India |
Phone |
|
Fax |
|
Email |
dr.vipin28@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Mahatma gandhi hospital |
Address |
sitapura,tonk road, jaipur,
pin-302022 |
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 |
saurabh mittal |
Mahatma gandhi hospital |
Department of Organ transplant anaesthesia and critical care ,tonk road pin-302022 Jaipur RAJASTHAN |
8087439644
saurabh.mittal013@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: N186||End stage renal disease, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
sabarachnoid block |
In group M patients after thorough hand washing and wearing personal protective equipment’s, patients back will be cleaned and draped under all aseptic precautions as per the standard operating procedure protocol. With patient in sitting position, intervertebral space L3-L4 is palpated. A 25 G Quincke needle will be inserted and after confirmation of free flow of CSF, a total volume of 2 ml (200 mcg (0.2ml) morphine along with 1.8 ml normal saline) is injected. |
Comparator Agent |
usg guided erector spinae plane block |
in group E, patients will be given unilateral ultrasound guided erector spinae block with 20 ml of 0.5 % ropivacaine after induction of general anaesthesia following the same standard operating procedure protocol. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1 American Society of Anaesthesiologists (ASA) III patients
2 Age group of 20-60 years
3 Patient with written valid consent
4 Patient undergoing renal transplant surgery.
|
|
ExclusionCriteria |
Details |
1 Patient refusal
2 History of allergy to study drug
3 Contraindication to spinal puncture/regional block (e.g. bleeding diathesis, neurologic dysfunction, and recent systemic or local infection);
4 Insufficient comprehension to use the PCA device,
5 History of drug abuse,
6 Severe cardiovascular disease
7 Patient with neurological disorder
8 Recent use of psychoactive or analgesic medication.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate and compare the effect of intrathecal morphine versus ESPB in terms of duration and quality of analgesia and post operative analgesic consumption
|
postoperative hours
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Effect on catheter related bladder discomfort
To observe any procedure and drug related complications |
postoperative hours |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 4 |
Date of First Enrollment (India)
|
19/01/2023 |
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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Post operative pain is a major concern after any surgery.
Inadequate control of pain after major surgeries continues to be a cause of
worry since it may be associated with a delay in recovery leading to an
increase in incidence of chronic post surgical pain. At present, there are
numerous methods exist for post operative pain management after major abdominal
surgeries such as intrathecal or intravenous(I.V)opioids, epidural analgesia,
and ultrasound guided peripheral nerve blocks,however options for post‑kidney
transplantation analgesia are limited due to associated comorbidities in kidney
transplant recipients.
Ultrasound guided regional anaesthesia is an upcoming and rapidly progressive
method of pain management. The ultrasound guided erector spinae plane block
(ESPB) is a newer regional anaesthesia technique currently being explored as a viable option
for analgesia. ESPB is performed by injecting local anaesthetic in the plane
between the erector spinae muscle and transverse process. Both intrathecal
morphine and ESPB has been investigated for use in post-operative analgesia for
various surgeries like total abdominal hysterectomy, laparoscopic
cholecystectomy, percutaneous nephrolithotomy, open nephrectomy, but there are
very limited studies in regarding there use in kidney transplant recepients. With the hypothesis that both intra-thecal morphine and ultrasound
guided ESPB has effect on post operative pain management So, this study is
being planned to compare and evaluate
both modalities and observe the duration, quality of analgesia and post
operative analgesic consumption in the patients undergoing kidney
transplantation.
|