| CTRI Number |
CTRI/2024/08/072494 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| 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
|
Comparison of Quadratus Lumborum Block using Bupivacaine with Dexmedetomidine with Intrathecal Morphine for pain relief in Laparoscopic Nephrectomies-A randomized study |
|
Scientific Title of Study
|
Comparison of Quadratus Lumborum Block using Bupivacaine with Dexmedetomidine versus Intrathecal Morphine 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
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
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
drneha.com@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya Muduli |
| Designation |
Junior Resident |
| 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
Khordha
ORISSA
751019
India |
| Phone |
8895053317 |
| Fax |
|
| Email |
supu1999@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, 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
Khordha
ORISSA
Khordha
ORISSA |
9438884045
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: N259||Disorder resulting from impaired renal tubular function, unspecified, (2) ICD-10 Condition: N158||Other specified renal tubulo-interstitial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bilateral QL Block using 40 ml 0.25% bupivacaine with dexmedetomidine (1 mcg/kg). |
Bilateral QL Block using 40 ml 0.25% bupivacaine with dexmedetomidine (1 mcg/kg) after induction of the Anesthesia. |
| Intervention |
Intrathecal Morphine at 3 mcg/ kg. |
Intrathecal Morphine at 3 mcg/ kg before induction of Anesthesia. |
|
|
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, ITM
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 rescue analgesia as Oral morphine milligram equivalent ( OMME) over 24 hours. |
First 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numeric Rating Scale (NRS) scores at 2,4,8,12,18, & 24hrs
b) Total dose of Intraoperative Opioid used
c) Time to request of first rescue analgesia and number of doses
d)Postoperative complications -Nausea/Vomiting/Pruritus/
respiratory depression/bradycardia/dizziness
e)Ramsay sedation score (RSS)
f) Quality of recovery 15(QoR 15) and Bruggemann comfort scale (BCS)
g) 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="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2024 |
| Date of Study Completion (India) |
17/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 Nephrectomies are
complex surgical procedures that often result in significant postoperative
pain. Effective pain management is crucial for patient recovery and
satisfaction. Intrathecal Morphine (ITM) and various regional blocks like
Quadratus Lumborum Block (QLB), Erector Spinae Plane Block (ESPB), and
Transverse Abdominis Plane (TAP) Block have been used as a part of multimodal
analgesia. [1] Intrathecal Morphine (ITM) provide better analgesia
for around 24 hours at a significantly lower dose in comparison to
intravenous opioids [2]. However, it does have an increased risk for side
effects like pruritus, nausea, vomiting, and respiratory depression. There
is paucity of clinical studies exploring the comparative efficacy of
Intrathecal Morphine versus Quadratus Lumborum block using Bupivacaine with
Dexmedetomidine in laparoscopic nephrectomies, so we have planned this study to
compare these two modalities.
References:
1. Srinivasan S, Subramaniam R,
Chhabra A, Baidya D, Arora M, Maitra S, et al. Comparison of transversus
abdominis plane block and intrathecal morphine for laparoscopic donor nephrectomy: Randomized controlled trial.
Indian J Anaesth. 2020 Jun 1;64(6):507–12. ​
2. Koning M V., Klimek M, Rijs
K, Stolker RJ, Heesen MA. Intrathecal hydrophilic opioids for abdominal
surgery: a meta-analysis, meta-regression, and trial sequential analysis. Vol.
125, British Journal of Anaesthesia. Elsevier Ltd; 2020. p. 358–72. |