| CTRI Number |
CTRI/2023/07/054971 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the outcome of two spinal drugs on patients in Percutaneous Nephrolithotomy |
|
Scientific Title of Study
|
A Comparative Study to evaluate the efficacy between Ropivacaine 0.75% with Nalbuphine and Bupivacaine 0.5% with Nalbuphine in Spinal Anaesthesia for Percutaneous Nephrolithotomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Dev |
| Designation |
Associate Professor, Department Of Anaesthesia |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Room no 105, Dept. of Anaesthesiology, OPD building, NEIGRIHMS Hospital, Mawdiangdiang, Shillong-793018
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
07577055859 |
| Fax |
|
| Email |
priyanka8ap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunny |
| Designation |
Assistant Professor, Department Of Anaesthesia |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Room no 104, Dept. of Anaesthesiology, OPD building, NEIGRIHMS Hospital, Mawdiangdiang, Shillong-793018
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
08259064008 |
| Fax |
|
| Email |
aggarwalsunny87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Dev |
| Designation |
Associate Professor, Department Of Anaesthesia |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Room no 105, Dept. of Anaesthesiology, OPD building, NEIGRIHMS Hospital, Mawdiangdiang, Shillong-793018
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
07577055859 |
| Fax |
|
| Email |
priyanka8ap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Monetary support : NIL
Material support: North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) |
|
|
Primary Sponsor
|
| Name |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) |
| Address |
Mawdiangdiang, Shillong, East Khasi Hills, Meghalaya
Pin: 793018 |
| Type of Sponsor |
Government 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 |
| DrPriyanka Dev |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences(NEIGRIHMS) Hospital |
Urology Operation theatre,no. 7, department of Anaesthesiology
East Khasi Hills
MEGHALAYA |
07577055859
Priyanka8ap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 5th Institutional Ethics Committee, NEIGRIHMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group-B: Bupivacaine group |
This group will receive single dose of 3.2 ml 0.5% Bupivacaine (heavy) + 2mg Nalbuphine in spinal anaesthesia undergoing Percutaneous Nephrolithotomy (PNCL) prior to the operation. |
| Intervention |
Group-R: Ropivacaine group |
This group will receive single dose of 3.2 ml 0.75% Ropivacaine (heavy) + 2mg Nalbuphine in spinal anaesthesia undergoing Percutaneous Nephrolithotomy (PNCL) just prior to the operation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective PCNL
ASA physical status I & II
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal
Patient with known allergy to the drugs used in the study
Hemodynamic instability.
Coagulopathy
Patients with significant cardiac, respiratory and hepatic dysfunction
• Spinal deformity
• Local infection at injection site
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the onset, duration and intensity of spinal anaesthesia as well as duration of postoperative pain relief. |
Intraoperative and 24hrs postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative hemodynamic changes and incidence of complications. |
Intra-operative |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
prospective randomized study will be conducted on patients undergoing PCNL
under spinal anaesthesia (SA). Patients will be randomized by simple random
sampling into two groups, n=40, after verifying the inclusion an exclusion
criteria. This study will compare the onset, duration and intensity of SA,
duration of postoperative pain relief as well as intraoperative hemodynamic
changes and incidence of complications when either hyperbaric ropivacaine 0.75%
or hyperbaric bupivacaine 0.5% is combined with 2mg nalbuphine in spinal
anaesthesia used for PCNL. This study will guide to select better drug
combination and drug profile for PCNL which will be beneficial to the patient.
With the use of either ropivacaine with nalbuphine or bupivacaine with
nalbuphine in SAB for PCNL, it is expected to have hemodynamic stability,
decrease complications, decrease PONV, decrease post-operative pain and also
decrease length of hospital stay.
Once
patient is shifted to the operating room, ASA standard monitor will be
connected and baseline BP, HR, Sp02 will recorded and monitored throughout the
procedure. Both groups will receive SA in sitting position in L2-L3
intervertebral space using 27G Quincke spinal needle.
Group-R(n=40):
Ropivacaine group=3.2 ml 0.75% Ropivacaine (heavy) + 2mg Nalbuphine
Group-B(n=40):
Bupivacaine group=3.2 ml 0.5% Bupivacaine (heavy) + 2mg Nalbuphine
Sensory
blockade will be evaluated every 30 seconds and motor blockade will be assessed
by Modified Bromage scale till the block height of T6 is attained.
All
patients will be monitored with non-invasive multiparameters (SBP, DBP, MAP,
HR) every two minutes for the first 10 minutes than every five minutes during
and till the end of the surgery and every 20 minutes in the Post-Anaesthetic
Care Unit (PACU).
Patients
will be observed for 24 hrs for pain with NRS scoring (0-10, 0=No pain &
10= Worst pain).
Patients
will be also observed and noted for any postoperative complications like nausea,
vomiting, hypotension (SBP≤ 90mmhg), bradycardia (PR≤ 60/min), back pain and postural
headache. The complications will be treated with appropriate measures. |