CTRI Number |
CTRI/2022/02/040346 [Registered on: 16/02/2022] Trial Registered Prospectively |
Last Modified On: |
15/02/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
The Comparison Of Two Fascial Plane Blocks For Post Operative Analgesia In Abdominal Surgeries. |
Scientific Title of Study
|
The Comparative Evaluation Of Ultrasound Guided Quadratus Lumborum And Erector Spinae Block For Post Operative Analgesia In Abdominal Surgeries. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Divya Gupta |
Designation |
Professor |
Affiliation |
Himalayan Institute Of Medical Sciences |
Address |
Department of Anaesthesia,Pain Management and Critical Care.
Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant.
Dehradun UTTARANCHAL 248140 India |
Phone |
9456570288 |
Fax |
|
Email |
divyagupta@srhu.edu.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manjot Kaur Ahluwalia |
Designation |
Post Graduate Resident |
Affiliation |
Himalayan Institute Of Medical Sciences |
Address |
Department of Anaesthesia,Pain Management and Critical Care.
Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant.
Dehradun UTTARANCHAL 248140 India |
Phone |
8437973351 |
Fax |
|
Email |
manjotkaur0194@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manjot Kaur Ahluwalia |
Designation |
Post Graduate Resident |
Affiliation |
Himalayan Institute Of Medical Sciences |
Address |
Department of Anaesthesia,Pain Management and Critical Care.
Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant.
Dehradun UTTARANCHAL 248140 India |
Phone |
8437973351 |
Fax |
|
Email |
manjotkaur0194@gmail.com |
|
Source of Monetary or Material Support
|
Department Of Anaesthesia,Pain Management and Critical Care
Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant |
|
Primary Sponsor
|
Name |
Himalayan Institute Of Medical Sciences |
Address |
Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant,Dehradun |
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 |
Dr Manjot Kaur Ahluwalia |
Himalayan Institute Of Medical Sciences |
Induction Room, Pre op area, Operation Theatre first floor, Department of Anaesthesia ,Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University, Jolly Grant Dehradun UTTARANCHAL |
8437973351
manjotkaur0194@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: K638||Other specified diseases of intestine, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1)Age - 18-65 Years
2)Gender– Both male and female patient
3)Physical Status :American Society of Anesthesiologists (ASA) I and II patients
scheduled to undergo upper abdominal surgeries with midline incision
|
|
ExclusionCriteria |
Details |
1)American Society of Anaesthesiologists(ASA) physical status more than or equal to III patients
2)Local infection at the site of block
3)H/o allergy to study medications
4)Patients on chronic pain relief medications
5)Allergic to local anesthetics
6)Bleeding disorders
7)Dyselectrolytemias
8)Patient on anti-coagulants
9)Inability to give informed consent
10)Severe cardiovascular , respiratory, liver and kidney disease
11)Patient who cannot operate Patient Controlled Analgesia (PCA) system
12)Psychiatric disorders
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To observe and evaluate post operative analgesic efficacy of ultrasound guided Bilateral Quadratus Lumborum block and Bilateral Erector Spinae block in abdominal surgeries with midline incision. |
To observe the total post operative fentanyl consumption over 24 hrs after administration of each block in either group and to study pain intensity at 0,4,8,12,16,20 and 24 hrs intervals respectively. |
|
Secondary Outcome
|
Outcome |
TimePoints |
The secondary outcome variable will be Motor block.It will be evaluated using modified Bromage Score. |
It will be calculated at time points 0,4,8,12,16,20 and 24 h after anesthesia recovery. |
|
Target Sample Size
|
Total Sample Size="67" Sample Size from India="67"
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)
|
16/02/2022 |
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
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The
International Association for the Study of Pain (IASP) defines pain as “an
unpleasant sensory and emotional experience associated with actual or potential
tissue damage, or described in terms of such damageâ€.
Post-operative
pain is a problem for many patients and affects recovery, risk of
post-operative complications and quality of life. A thorough preoperative
evaluation, careful perioperative planning, identification, and individualized
treatment of high-risk patients can reduce post-operative pain. Multimodal
treatment combines different analgesic techniques in order to utilize
synergistic and additive effects of different treatments and has the potential
to optimize effects and reduce side effects.
Currently,
various modalities for post-operative pain management exist. Traditionally
opioids ,NSAIDS and Paracetamol were used as the main agents for post-operative
analgesia.Newer modalities include Patient Control Analgesia (PCA) pumps, epidural neuraxial blocks and peripheral nerve blocks.
With multimodal approach there is decrease in opioid requirement and at the
same time reduction in side effects due to opioids such as nausea, vomiting,
drowsiness and constipation.
There is an
increasing trend toward the use of peripheral nerve blocks for post-operative
pain control. They are one of the safest and most effective methods to control
pain from surgery.For post- operative pain control nerve blocks can be
given alone or as a component of multimodal analgesia. In a peripheral nerve
block, anaesthetic drug is injected at a particular site around the nerves
which then stop the pain signal to reach the brain, thus provides analgesia.
Peripheral nerve block can be given as a single injection (sPNB), when
post-operative pain is of short duration or as a continuous catheter infusion
(cPNB), when prolonged post-operative analgesia is required .
Uncontrolled
pain after abdominal surgery increases the incidence of postoperative
complications, as it prolongs hospitalization, and increases health care costs
and the use of opioids.Interfacial plane blocks such
as Quadratus Lumborum block (QLB) and Errector Spinae block are the new
emerging modalities, performed by ultrasound guidance, that are being put to
use for post operative analgesia in patients undergoing abdominal surgeries.
Quadratus
lumborum block has been used for postoperative analgesia in patients undergoing
upper abdominal surgeries. The analgesia is achieved in T7–L1 dermatomes,with cranial
spread to T4–T5 and caudal spread to L2–L3 dermatomes. Quadratus lumborum block 3 implies the application of the
local anesthetic between the QLM and the psoas major muscle (PMM) at the front
of the QLM, at the level of its attachment to the transverse process of L4
vertebra.
Erector spinae block (ESB) is an interfascial
plane block in which anaesthetic drug is injected between anterior surface of
Erector spinae muscle and transverse process of underlying vertebra. It acts
by blocking dorsal and ventral rami of spinal nerves .Block will be performed
at the T9 level in our study.
Ropivacaine is a
long-acting amide local anaesthetic agent and first produced as a pure
enantiomer .It produces effects similar to other local anaesthetics via
reversible inhibition of sodium ion influx in nerve fibres. Ropivacaine is less
lipophilic than bupivacaine and is less likely to penetrate large myelinated
motor fibres, resulting in a relatively reduced motor blockade.Thus,
ropivacaine has a greater degree of motor sensory differentiation, which could
be useful when motor blockade is undesirable. The reduced lipophilicity is also
associated with decreased potential for central nervous system toxicity and
cardiotoxicity.
Patient controlled analgesia (PCA) is another
modality which is given along with
peripheral nerve blocks to reduce post-operative pain. PCA allow patient
to control his desired level of analgesia which ultimately lead to patient
satisfaction .
The above mentioned nerve blocks have been
studied and used in the management of postoperative pain in patients undergoing
upper abdominal surgeries with variable results. So, in this study we will be
comparing the effectiveness of Quadratus lumborum block and Erector spinae
plane block along with PCA for post-operative pain management in abdominal
surgeries with midline incision. Sample
Size:
n= (Z2a/2
p(1-p)
d2
Z α/2 = 1.96 at 5% level of significance
p = prevalence
Here, we conside p=50%
p=505=0.5
1-p=1-0.5=0.5
d=adsolute pricisim
d=12%=0.12
n= (1.96)2x(0.5)x(0.5)
(0.12)2
n= 3.84x0.25
0.0144
n=66.66
n = 67
So, the sample size is 67.
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