| CTRI Number |
CTRI/2019/01/016825 [Registered on: 01/01/2019] Trial Registered Prospectively |
| Last Modified On: |
30/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Small Scale Experimental Study To Compare The Pain Relieving Effect Of Two Techniques In Patients Undergoing Percutaneous Nephrolithotomy Surgery |
|
Scientific Title of Study
|
Analgesic Efficacy Of Ultrasound Guided Erector Spinae Block Versus Intrathecal Morphine In Patients Undergoing Percutaneous Nephrolithotomy Surgery: A Prospective Randomised Comparative Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhurjya Baishya |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
House No. B54, Block B, South Extension Part 2, New Delhi-110049
New Delhi
DELHI
110049
India |
| Phone |
8414865181 |
| Fax |
|
| Email |
madhurjyabaishya121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravinder Kumar Pandey |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 5018, 5th Floor,Dept. of Anaesthesia, Pain medicine &Critical Care,AIIMS, New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9773500767 |
| Fax |
|
| Email |
ravindrapandey1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhurjya Baishya |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
House No. B54, Block B, South Extension Part 2, New Delhi-110049
New Delhi
DELHI
110049
India |
| Phone |
8414865181 |
| Fax |
|
| Email |
madhurjyabaishya121@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,Pain Medicine & Critical care, All India Institute Of Medical Sciences,Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
All India Institute Of Medical Sciences, Ansari Nagar, New Delhi-110029 |
| 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 |
| Madhurjya Baishya |
AIIMS, New Delhi |
Department of Anaesthesia, Pain medicine & Critical Care, 5 th Floor, Room no. 5014, All India Institute Of Medical Sciences,Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
8414865181
madhurjyabaishya121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduation Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20||Calculus of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal Morphine |
Under aseptic conditions, 150 mcg of preservative free morphine with 2ml of normal saline will be administered in any of the intrathecal spaces between L2-L5 vertebra level |
| Intervention |
Ultrasound guided Erector Spinae Block |
Under aseptic conditions, ultrasound guided erector spinae blockade will be performed between T9-T11 level with 20 ml of 0.375% ropivacaine and 0.5 mcg/kg clonidine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2 patients scheduled to undergo elective percutaneous nephrolithotomy surgery for renal and upper ureteric stone requiring bladder catheterization under general anesthesia. |
|
| ExclusionCriteria |
| Details |
1.Patients refusal
2.ASA III OR IV
3.Allergy to any of the study drugs 4.Contraindications to regional technique e.g., allergy to local anaesthetic drugs,
infection around site of block ,any coagulation disorder, sepsis
5. History of analgesic dependence (long term use) and opiate tolerance
6. Contraindications to intrathecal morphine e.g., local infection (administration site),
systemic infection, coagulopathy, raised intracranial pressure, metastatic disease of
the vertebral column, sleep apnoea syndrome, or a history of postdural puncture
headache (PDPH) or frequent headaches of any type.
7. Epilepsy and psychiatric disturbances |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative opioid consumption in Erector spinae block and Intrathecal Morphine Groups |
Intraoperatively fentanyl usefrom the beginning of the surgery till the end of surgery.
Postoperative fentanyl usage at 0 min, 30 mins,1 hr, 2 hrs, 4 hrs, 6 hrs and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic response to surgical stimulus during the procedure
2. Postoperative nausea and vomiting till 24 hours
3. Postoperative opioid consumption till 24 hours
4. Visual Analogue Scale score upon arrival in the PACU
5. Time to first analgesic requirement after surgery
6. Urethral irritation till 24 hours
7. Incidence of drug related side effects in both the groups |
1. Intraoperatively at induction of anaesthesia, 5 minutes after induction and at 10 mins, and every 10 mins till the end of surgery.
2-6.Postoperatively at 0 min,30 mins, 1 hr, 2 hrs, 4 hrs, 6 hrs, 24 hrs.
7. Intraoperatively at 0 mins after the procedure and every 10 mins till end of surgery and postoperatively at 0 min, 30 mins, 1 hr, 2 hrs, 4 hrs, 6 hrs and 24 hrs. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Many modalities like Intravenous opioids, local anaesthetic infiltration, intrathecal nerve blocks, regional nerve blocks like paravertebral and intercostal blocks have been used traditionally to control pain after PCNL surgery. However the efficacy of these blocks has not been proved. The erector spinae block is a relatively newer technique that reportedly provides effective analgesia after abdominal surgery. We hypothesise that erector spinae blockade will provide adequate analgesia with less side effects compare to intrathecal morphine in patients undergoing Percutaneous Nephrolithotomy surgery. |