| CTRI Number |
CTRI/2024/11/076523 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of one vs both side Quadratus Lumborum Block using Bupivacaine with Dexmedetomidine for Postoperative pain relief in Laparoscopic Nephrectomies: A randomized study. |
|
Scientific Title of Study
|
Comparison of unilateral versus bilateral Quadratus Lumborum Block using Bupivacaine with Dexmedetomidine for Postoperative Analgesia in Laparoscopic Nephrectomies: A randomized 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 Neha Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
drneha.com@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
drneha.com@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
drneha.com@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar, PIN-751019, Odisha India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar Odisha India |
| Address |
All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar, PIN-751019,
Odisha India |
| 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 Neha Singh |
All India Institute of Medical Sciences, Bhubaneswar |
Department of Anesthesiology and Critical care, Pre-operative areas, Operation theatre complexes, Postoperative recovery areas and Wards, AIIMS, Bhubaneswar Khordha ORISSA India
Khordha
ORISSA |
09438884045
drneha.com@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N398||Other specified disorders of urinary system. Ayurveda Condition: VRUKKAJAVIDRADHIH, (2) ICD-10 Condition:N159||Renal tubulo-interstitial disease,unspecified. Ayurveda Condition: VRUKKAJAVIDRADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: Unilateral QLB, Procedure details: Bupivacaine 0.25% 30 mL with inj. dexmedetomidine 1 mcg/kg will be injected on the anterior aspect of the muscle on the side of the surgery.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Bilateral QLB | Bupivacaine 0.25% 40 mL with inj. dexmedetomidine 1 mcg/kg will be taken and 20 mL will be injected on the anterior aspect of the muscle on each side. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II, 18-75 years male &female patients planned for laparoscopic nephrectomy surgery. |
|
| ExclusionCriteria |
| Details |
Patients with known allergy to the drugs used
Patients with contraindications for QLB
Patient refusal for consent
BMI more than 35 |
|
|
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 postoperative Numeric rating Scale (NRS) scores over 24 hours. |
To compare postoperative Numeric rating Scale (NRS) scores over 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Time to request of first rescue analgesia and number of doses
b) Total dose of Intraoperative Opioid used
c) Numeric Rating Scale (NRS) scores at 2,4,8,12,18, & 24 hrs
d) Time taken to perform block
e) Postoperative complications - Nausea/Vomiting/bradycardia/dizziness/Pruritus/ Respiratory Depression
f) Ramsay sedation score (RSS)
g) Quality of recovery 15(QoR 15) and Bruggemann comfort scale (BCS)
h) Length of hospital stay and CPSP (Chronic Postsurgical Pain) at 3 months. |
First postoperative 24 hours to 3 months. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
19/11/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Effective pain management after Laparoscopic Nephrectomy is of pivotal for postoperative recovery and patient satisfaction. Various regional blocks like Quadratus Lumborum Block (QLB), Erector Spinae Plane Block (ESPB), and Transverse Abdominis Plane (TAP) Block have been used in nephrectomies. Among the facial plane blocks, QLB effectively decreases opioid requirements, pain scores, and associated side effects in patients undergoing nephrectomy [1]. Both unilateral and bilateral QLBs were used for analgesia, but still not compared for analgesic effect. Preoperative unilateral QLB in laparoscopic-assisted nephrectomy successfully decreased postoperative pain and perioperative opioid consumption [2]. Bilateral QLB techniques showed comparable postoperative analgesic properties with epidural among living kidney donors undergoing laparoscopic nephrectomy [3-4]. So, we have planned this study to compare the unilateral vs bilateral QLB using Bupivacaine with Dexmedetomidine in laparoscopic nephrectomies. References: 1. Little C, Rahman S. Quadratus Lumborum Blocks in Nephrectomy: A Narrative Review. Local Reg Anesth. 2021 Apr 19;14:57-65. 2. Li Y, Wang L, Sun J, Xie T, Fu J, Feng C, Lu G. Effects of Subcostal Anterior Quadratus Lumborum Block with and without Dexmedetomidine on Postoperative Rehabilitation in Patients Undergoing Laparoscopic Renal Surgery: A Prospective Double-Blinded Randomized Controlled Study. Drug Des Devel Ther. 2023 Nov 10;17:3281-3293. 3. Rahendra R, Pryambodho P, Aditianingsih D, Sukmono RB, Tantri A, Melati AC. Comparison of IL-6 and CRP Concentration Between Quadratus Lumborum and Epidural Blockade Among Living Kidney Donors: A Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 28;9(2): e91527. 4. Aditianingsih D, Pryambodho, Anasy N, Tantri AR, Mochtar CA. A randomized controlled trial on analgesic effect of repeated Quadratus Lumborum block versus continuous epidural analgesia following laparoscopic nephrectomy. BMC Anesthesiol. 2019 Dec 5;19(1):221. doi: 10.1186/s12871-019-0891-7. PMID: 31805855; PMCID: PMC6894195. |