| CTRI Number |
CTRI/2024/05/067299 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Pain Relief After Surgery: Side Muscle Block vs. Abdominal Wall Block in patients undergoing Gallbladder Removal |
|
Scientific Title of Study
|
Comparison of duration of postoperative analgesia after lateral quadratus lumborum block versus subcostal transversus abdominis plane block in laparoscopic cholecystectomy- A randomised controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Riya Ravindran |
| Designation |
Postgraduate resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
2nd floor, Block B, Departmet of Anaesthesiology Bangalore Medical College and
Research Institute KR Road,Fort,Bangalore-560002
Bangalore KARNATAKA 560002 India |
| Phone |
08884342540 |
| Fax |
|
| Email |
riyaravindran4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saraswathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
2nd floor, Block B, Department of Anaesthesiology
Bangalore Medical College and Research Institute,Bangalore
Fort,K R Road Bangalore-560002
Bangalore KARNATAKA 560002 India |
| Phone |
9663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Saraswathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
2nd floor,B block,Department of Anaesthesiology,
Bangalore Medical College and Research Institute, Bangalore
Fort, K R Road Bangalore-560002
Bangalore KARNATAKA 560002 India |
| Phone |
9663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and
Research Institute, KR Road,Fort,Bangalore, Karnataka, India-560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Bangalore Medical College and Research Institute,KR Road ,Fort,
Bangalore -560002 |
| 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 |
| Dr Riya Ravindran |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology,
2nd floor, Block B, BMCRI,Bangalore
Fort,K R Road Bangalore-560002 Bangalore KARNATAKA |
08884342540
riyaravindran4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
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 |
Ultrasound guided lateral quadratus lumborum block |
Lateral quadratus lumborum block given under ultrasound guidance with 0.25% Levobupivacaine with Dexamethasone 8mg bilaterally once after the surgery, before extubation for postoperative analgesia in laparoscopic cholecystectomy |
| Comparator Agent |
Ultrasound guided subcostal transversus abdominis plane block |
Subcostal transversus abdominis plane block given under ultrasound guidance with 0.25% Levobupivacaine with Dexamethasone 8mg bilaterally ,once after the surgery before extubation for postoperative analgesia in laparoscopic cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to give informed consent.
Patients of age 18-60 years.
ASA grade 1 & 2.
Patients with BMI 18.5-25.
Patients undergoing laparoscopic cholecystectomy.
|
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patients with history of coagulopathy.
Patients with history of allergic to local anaesthetic.
Patients with severe systemic diseases.
Psychiatric illness.
Chronic medication taking for pain.
Patient requiring postoperative mechanical ventilation.
Localized infection over injection point.
Duration of surgery more than 3 hours.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess postoperative analgesia using VAS score |
To assess VAS score at 30 minutes, 60minutes, 1hour, 2hour, 4hour,8hour,12hour,24hour postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need of rescue analgesia |
Time of requirement of first dose od Inj.Tramadol 2mg per kg body weight |
| Hemodynamic parameters like Heart rate, blood pressue and spO2 |
Assess heart rate, blood pressure, spO2 at 30 minutes, 60minutes, 1hour, 2hour, 4hour,8hour,12hour,24hour postoperatively |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
03/06/2024 |
| 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="6" 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
|
|
Laparoscopic surgery is nowadays a
common technique used in variety of abdominal surgeries including
cholecystectomy, appendicectomy, inguinal hernia repair, hemicolectomy etc. Eventhough
post-operative pain after laparoscopy is lesser than in open operative
techniques, the abdomen stiffness due to the pneumoperitoneum (created as a
step of the laparoscopic approach) and operative manipulations may cause severe postoperative pain that
will affect the patient satisfaction and the outcome of the surgery.1
The various modes of pain
management include parenteral administration of opioids, NSAIDs, wound infiltration with
local anaesthetics, neuraxial
anaesthesia, peripheral nerve blocks.etc. Multimodal approach provide better
pain control. But these techniques are associated with drawbacks- opioids are associated with vomiting,
pruritus, oversedation and respiratory depression;NSAIDs can cause
nausea, vomiting and gastric irritation,etc. Regional anesthesia techniques can be used as sole anesthetic technique or adjuvant to general
anesthesia for intra operative and postoperative analgesia.2
The transversus abdominis plane
(TAP)block, first introduced by Rafi in 2001 as a landmark-guided technique
via the triangle of Petit to achieve a field block. It involves the injection
of a local anesthetic solution into the plane between the internal oblique
muscle and transversus abdominis muscle.The local anesthetic spread in this
plane can block the neural afferents and provide analgesia to the
anterolateral abdominal wall, as the thoracolumbar nerves originating from
the T6 to L1 spinal roots run into this plane and supply sensory nerves to
the anterolateral abdominal wall.3USG facilitates accurate
placement of block needle and real time deposition of local anaesthetic,
increasing both margin of safety and block quality.4
Quadratus lumborum block is a block of
the posterior abdominal wall, “interfascial plane block†which is performed
under ultrasound guidance. It was described by anaesthesiologist Dr. Rafael
Blanco as a variant of TAP block in 2007.Today four types of QL block are
performed which differ by the site of drug application. These are QLB1or
lateral QLB, QLB2 or posterior QLB, QLB3 or anterior /transmuscular QLB and
QLB4 or intramuscular QLB. QLB1 or lateral QLB implies the application of
local anaesthetics on the lateral side of the QLM on the area of its contact
with transverasalis fascia, at the level where tranversus abdominis muscle
taper off to its aponeurosis.5
This
study is aimed to compare and evaluate the analgesic effectiveness between Lateral
QLB and subcostal TAPB after
laparoscopic cholecystectomy.
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