| CTRI Number |
CTRI/2022/10/046348 [Registered on: 11/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Does pain killer at erector spinae plane effective in relieving post op pain after kidney stone removal Surgery?
|
|
Scientific Title of Study
|
Efficacy of ultrasound Guided Erector Spinae Plane Block in Percutaneous Nephrolithotomy (PCNL)Surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr Satya Prakash Pandey |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai,Etawah |
| Address |
Department of Anesthesiology,
UPUMS, Saifai UPUMS, Saifai Etawah UTTAR PRADESH 206130 India |
| Phone |
8266882902 |
| Fax |
|
| Email |
satyapriyasnmc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR URVASHI YADAV |
| Designation |
professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai,Etawah |
| Address |
Department of Anesthesiology,
UPUMS, Saifai UPUMS, Saifai Etawah UTTAR PRADESH 206130 India |
| Phone |
07500186161 |
| Fax |
|
| Email |
drurvikgmu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
dr Satya Prakash Pandey |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai,Etawah |
| Address |
Department of Anesthesiology,
UPUMS, Saifai UPUMS, Saifai Etawah UTTAR PRADESH 206130 India |
| Phone |
8266882902 |
| Fax |
|
| Email |
satyapriyasnmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Saifai |
|
|
Primary Sponsor
|
| Name |
UPUMS, Saifai |
| Address |
Department of Anaesthesiology,
UPUMS, Saifai, Etawah |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Satya Prakash Pandey |
UPUMS, SAIFAI |
Department of Anaesthsia, UPUMS Saifai Etawah UTTAR PRADESH |
8266882902
satyapriyasnmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethical committee of University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane BLOCK with Local Anaesthetic |
After completion of surgery group E will receive Erector Spinae Plane Block with Local Anaesthetic (LA) mixture 10 ml of 0.5% Bupivacaine, 5 ml of Lignocaine 2%, 1 ml (50mcg) of fentanyl, 4 ml of NS to make a mixture of 20 ml, which will be injected on the side of surgery under ultrasound guidance. It will take 5 to 10 min to locate and injust the study drug. |
| Comparator Agent |
Erector Spinae Plane Block with Normal Saline |
After completion of surgery Group C will receive Erector Spinae Plane Block with 20 ml of normal saline injected on the side of surgery under ultrasound guidance. The procedure will take 5 to 10 min approximately. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
. ASA I and II
2. Patients between the age of 35-65 years
3. Patients with body mass index between 18-30 kg/m2 [BMI 18-30 kg/m2]
4. Pt. posted for elective PCNL surgery.
5. Duration of surgery between 90-120 minutes.
|
|
| ExclusionCriteria |
| Details |
. Patients refusal.
2. Neuro Psychiatric Disorder or on Chronic use of Psychoactive medications.
3. Hepatic impairment.
4. History of Epilepsy.
6. Pregnant and lactating females.
7. History of alcohol and drug abuse.
8. Coagulation abnormality.
9 Allergy to any study drug.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative Pain by VAS Scores |
30 min, 2h, 6h,12h and 24h postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Rescue Analgesic Required |
in 24 h |
| Satisfaction level |
12 h after surgery |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published in Cureus journal of medical sciences |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A sealed envelope randomization will
be employed to allocate patients into
two groups either to receive
ESP block with local anaesthetic drug bupivacaine and patient receiving ESP block
with normal saline.
Patient will be premedicated with
intravenous inj. glycopyrrolate (5mcg/kg), inj. Midazolam (0.05mg/kg), inj.
Fentanyl (2mcg/kg). Induction will be achieved by inj. Propofol (2mg/kg) and intubation will be
facilitated with inj. vecuronium (0.08mg/kg). Anaesthesia will be maintained
with 50% of nitrous oxide in oxygen and isoflurane along with inj.
vecuronium(0.02mg/kg) maintenance dose as required. All hemodynamics parameter will be recorded
at every 15 min interval until patient will be shifted from the operating room.
Erector
spinae plane block will
be performed after completion of
pcnl surgery under ultrasound
guidance using a
linear transducer.
Group E (n=30): group E will receive Erector
Spinae Plane Block with Local Anaesthetic (LA) mixture 10 ml
of 0.5% Bupivacaine, 5 ml of Lignocaine
2%, 1 ml (50mcg) of fentanyl, 4 ml of NS to
make a mixture
of 20 ml, which will be injected on the side of surgery.
Group C (n=30): group C will
receive Erector Spinae Plane Block
with 20 ml of normal saline injected
on the side of surgery.
In
Group E patients, Erector Spinae
Plane (ESP) block will
be performed in
prone position after ensuring
skin asepsis, we place
high frequency [5-13 MHz] linear
ultrasound transducer in
sterile sheath 3 cm lateral to the T9 spinous
process
to visualize the back muscles:
trapezius above, rhomboid major in
the middle, and erector spinae muscle on
the bottom. A 23G 10-cm Touhy needle will
be inserted using an
in plane superior to inferior approach until the needle touched the Transverse
Process crossing all three muscles. A
volume of 20 ml of
LA mixture will be
injected.
In Group
C patients, same procedure as above will be
performed, but in place of drug we will inject a volume of 20 ml of normal saline on the surgery side.
After completion of ESP block
procedure, all the anaesthetic agent
will be stopped and after the onset of spontaneous respiration, residual
neuromuscular blockade will be reversed with Inj. Neostigmine (5mcg/kg) and
Inj. Glycopyrrolate (10 mcg/kg) and extubation will be done
. before shifting the pts to postoperative ward we will give injection
paracetamol 15mg/kg body wt as analgesic to all pts.
PTs will be assessed for pain by VAS
scores (ranging from 0 indicating no pain to 10 indicate extreme pain) will be
recorded 30 min and 2,4,6,12,and 24 hr. postoperatively.
When VAS
Score is more then 4 we will give intravenous tramadol 100 mg (maximum up to
400 mg) as postoperative rescue analgesic. . The amount
of rescue analgesia require
in both groups during first 24
h after operation , pts satisfaction
score using Likert Verbal Rating Scale
and complications if any occur will be recorded.
The hemodynamic
parameters like Heart rate, Systolic Blood pressure,
Diastolic blood pressure , Mean arterial pressure, Saturation(spo2), Etco2
will be
taken after the
block and patients will
be monitered upto
24 hrs after
the block. Adverse
events such as
Bradycardia (HR <50 bpm or 20%
decrease from the baseline
value), Hypotension (fall in blood
pressure by 20%
from the baseline or an absolute
MAP <60 mmHg) , Nausea,
Vomiting, Dryness of
mouth or any
other events during
or within the
procedure will be
noted. Bradycardia will be treated
with increment doses
of injection Atropine 0.3mg and
Hypotension will be managed
with a bolus
of IV crystalloids
or with increments
of injection Mephentermine 6 mg. |