| CTRI Number |
CTRI/2021/02/031408 [Registered on: 19/02/2021] Trial Registered Prospectively |
| Last Modified On: |
18/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Quadratus Lumborum Type II Block vs Quadratus Lumborum Type III Block in patients undergoing Total Laparoscopic Hysterectomy |
|
Scientific Title of Study
|
Comparison of two approaches of Quadratus Lumborum Block for Peri Operative Analgesia in patients undergoing Total Laparoscopic Hysterectomy – A Randomised Double-Blind Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavan Kumar Kandrakonda |
| Designation |
JR IN MD ANAESTHESIOLOGY |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA |
| Address |
Department of Anaesthesiology, AIIMS Patna, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7989652367 |
| Fax |
|
| Email |
dr.p4v4nkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajnish Kumar |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA |
| Address |
Department of Anaesthesiology, AIIMS Patna, Patna, Bihar.
Patna
BIHAR
801507
India |
| Phone |
7783865337 |
| Fax |
|
| Email |
drraj76pmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan Kumar Kandrakonda |
| Designation |
JR IN MD ANAESTHESIOLOGY |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA |
| Address |
Department of Anaesthesiology, AIIMS PATNA, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7989652367 |
| Fax |
|
| Email |
dr.p4v4nkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
Not Funded |
| Address |
N/A |
| Type of Sponsor |
Other [Nil] |
|
|
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 RAJNISH KUMAR |
AIIMS PATNA |
OPERATION THEATER, DEPARTMENT OF ANAESTHESIOLOGY, 5TH FLOOR IPD, AIIMS PATNA
Patna
BIHAR |
7783865337
drraj76pmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
QUADRATUS LUMBORUM TYPE II BLOCK |
QL Type II Block - under aseptic conditions, A curvilinear transducer will be placed in the axial plane in the midaxillary line and moved posteriorly, until the lateral interfascial triangle (LIFT), which encapsulates the paraspinal muscles, becomes visible between the latissimus dorsi and quadratus lumborum muscles. The target is the deep layer Paraspinal Retinacular Sheath (PRS) of the middle layer of the Thoraco Lumbar Fascia (TLF). The needle will be inserted from the lateral end of the transducer. The needle tip will be advanced until it is inside the middle layer of the TLF close to the LIFT. The local anesthetic will be injected intrafascially. |
| Intervention |
QUADRATUS LUMBORUM TYPE III BLOCK |
QL Type III Block - Under aseptic conditions, A curvilinear transducer for the transmuscular QL III block will be placed in the axial plane on the patient’s flank just cranial to the iliac crest. The “shamrock sign†will be visualized. The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represent the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1) All patients aged between 30-60 years.
2) ASA I & II
3) Patients undergoing Total Laparoscopic Hysterectomy
|
|
| ExclusionCriteria |
| Details |
1) Patient Refusal
2) Patients with underlying severe cardiopulmonary compromise
3) Total Laparoscopic Hysterectomy converted to Total Abdominal Hysterectomy
4) Morbid Obesity BMI more than or equal to 35
5) Allergy to Local Anaesthetics
6) Patients already on prescribed psychotropic agents
7) Coagulation Disorders |
|
|
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 compare the total amount of analgesic consumption in 24 hours |
To compare the total amount of analgesic consumption in 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time to first rescue analgesia
To compare the mean Numerical Rating Score (NRS) of pain, in first 24 hours (measured at 1, 6, 12 and 24 hrs.)
|
1st Hour, 6th Hour, 12th Hour, 24th Hour |
|
|
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)
|
22/02/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Total Laparoscopic
Hysterectomy is one of the regularly done laparoscopic surgeries in many parts
of the world. The postoperative pain
following Total Laparoscopic Hysterectomy might be because of pneumoperitoneum,
intra-abdominal peritoneal stretching and from operated area in pelvic region,
which is mainly visceral type. Thus, single mode of analgesia, most commonly by
NSAIDS or Opioids is not enough for the patient to have a smooth postoperative
recovery. The quadratus lumborum block is a
new abdominal truncal block used for analgesia of both the upper and lower
abdominal surgeries. Quadratus lumborum block allows the local spread of drugs
between the posterior aspect of muscle and middle layer of thoracolumbar
fascia. The Hypothesis of this study is that Quadratus Lumborum Type III block will provide better perioperative analgesia and decrease the total analgesic consumption in postoperative period.
|