| CTRI Number |
CTRI/2024/05/067730 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different concentrations of Ropivacaine local anaesthetic for postoperative pain relief in abdominal hysterectomy surgeries |
|
Scientific Title of Study
|
Comparison of Epidural Infusion of 0.1% Ropivacaine and 0.2% Ropivacaine for Postoperative Analgesia using Elastomeric Pump in Abdominal Hysterectomies - A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadharshini S |
| Designation |
Post Graduate |
| Affiliation |
SRM Medical College Hospital and Research Institute |
| Address |
Department of Anaesthesiology SRM Medical college hospital Potheri Kattankulathur Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9655657414 |
| Fax |
|
| Email |
prishali7696@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Karthik |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital and Research Institute |
| Address |
Department of Anaesthesiology SRM Medical college hospital Potheri Kattankulathur Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9994122396 |
| Fax |
|
| Email |
drkarthik.cpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Karthik |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital and Research Institute |
| Address |
Department of Anaesthesiology SRM Medical college hospital Potheri Kattankulathur Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9994122396 |
| Fax |
|
| Email |
drkarthik.cpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 1, B. Block,Department of Anaesthesiology SRM Medical College Hospital and Research institute Potheri Kattankulathur 603203 Kancheepuram Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Priyadharshini S |
| Address |
Department of Anaesthesiology SRM Medical College Hospital Potheri Kattankulathur Kancheepuram Tamilnadu 603203 |
| 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 |
| Priyadharshini S |
SRM Medical College Hospital |
Department of Anaesthesiology SRM Medical college hospital Potheri Kattankulathur Kancheepuram Tamilnadu 603203
Kancheepuram
TAMIL NADU |
9655657414
prishali7696@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N926||Irregular menstruation, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural infusion of 0.1% Ropivacaine for postoperative analgesia |
0.1% Ropivacaine is given as continuous epidural infusion using elastomeric pump in postoperative day 1 and 2 at the rate of 5ml/hour |
| Comparator Agent |
Epidural infusion of 0.2% Ropivacaine for postoperative analgesia |
0.2% Ropivacaine is given as continuous epidural infusion using elastomeric pump in postoperative day 1 and 2 at the rate of 5ml/hour |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Elective surgeries with ASA Grading 1,2 and 3
2.Patients undergoing abdominal hysterectomy
3.Weight from 50kg to 80kg
4.Height from 145cm to 165cm |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Allergic to Ropivacaine and Fentanyl
3.Local infection at the site of epidural injection
4.Coagulopathy
5.Hypovolemia
6.Patient on anticoagulant therapy
7.Uncooperative patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the VAS score at rest, movement and while coughing between the patients getting 0.1% and 0.2% ropivacaine as epidural infusion for pain relief |
The time duration taken by the patient to complain of pain with VAS more than 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the need for rescue analgesia |
The time duration taken by the patient to complain pain with VAS more than 5 even after giving rescue analgesia |
| To compare the motor blockade |
The time duration taken by the patient to complain of lower limb numbness |
| To compare haemodynamic changes |
The time duration taken for mean arterial pressure to fall less than 60 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Informed written consent will be taken from all the patients. Patients will be randomly divided into 2 groups, Group R1 (0.1% Ropivacaine) and Group R2 (0.2% Ropivacaine) utilising a computer generated table of random numbers before starting the procedure. On the day of surgery patients shifted onto the operating table and monitors attached. In both the groups, General anaesthesia and epidural anaesthesia will be performed by an anaesthesiologist. Epidural catheterisation is done using 16G,18G or 20G Tuohy’s needle at L2-L2 or L3-L4 space.Position of the catheter is confirmed. Post surgery patient is sent to Obstetric ICU for pain management and continuous epidural infusion using elastomeric pump at the rate of 5ml/hr is given. Fentanyl 2mcg/ml is added to the local anaesthetic of all the patients. Group allocation will be concealed by using coded sealed opaque envelopes which will be opened only by the attending doctor at Obstetric ICU. If patient complains of pain of VAS more than 3 and less than 5,rescue analgesia of Injection.Paracetamol 1gram iv will be given. If patient complains of pain of VAS more than 6 Injection.Tramadol 100/50 milligram iv will be given. Pulse oximeter, non invasive blood pressure and electrocardiogram will be continuously monitored throughout epidural infusion. Also VAS score at rest ,movement and while coughing will be assessed every 4-5 hourly.Other adverse effects such as motor blockade and hypotension will be assessed. Epidural infusion will be continuously given during postoperative day 1 and 2 for 48 hours. |