| CTRI Number |
CTRI/2025/11/097396 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| 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
|
A Study on How Modern Nerve Blocks Can Reduce Painkiller Use and Improve Recovery After Minimally Invasive Kidney Surgery
|
|
Scientific Title of Study
|
Ultrasound guided Quadratus lumborum block and Erector spinae
block on Opioid sparing effect and quality of recovery in minimally invasive Nephrectomy
A Prospective Randomized Comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ANA/QEN/095, version 1, dated 7/5/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandikonda Akhila |
| Designation |
MD Anaesthesia [junior resident] |
| Affiliation |
Nizams institute of medical science |
| Address |
Room 6,SPECIALITY BLOCK OT, 3rd floor,Department of Anaesthesia, Nizams institute of medical sciences, , Panjagutta, ,Hyderabad
Hyderabad TELANGANA 500082 India |
| Phone |
8106916091 |
| Fax |
|
| Email |
Nandikondaakhila9384@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Archana Pathy |
| Designation |
Additional professor, Department of Anaesthesia |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Room 1, mellinium block OT, 1st floor, Department of Anaesthesia, Nizams institute of medical sciences, Panjagutta, Hyderabad
Hyderabad TELANGANA 500082 India |
| Phone |
8885494278 |
| Fax |
|
| Email |
docarchana.pathy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Archana Pathy |
| Designation |
Additional professor, Department of Anaesthesia |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Room 1, mellinium block OT, 1st floor, Department of Anaesthesia, Nizams institute of medical sciences, Panjagutta, Hyderabad
Hyderabad TELANGANA 500082 India |
| Phone |
8885494278 |
| Fax |
|
| Email |
docarchana.pathy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr NANDIKONDA AKHILA |
| Address |
Room 6, speciality block OT, 3rd floor, Department of Anaesthesia, Nizams institute of medical sciences, panjagutta, hyderabad , pincode 500082 |
| Type of Sponsor |
Other [Self] |
|
|
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 NANDIKONDA AKHILA |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
Roon number 6, 3rd floor, Speciality block OT, Department of Anaesthesia, Panjagutta, Hyderabad Hyderabad TELANGANA |
8106916091
nandikondaakhila9384@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ERECTER SPINAE BLOCK |
Erecter spinae block : A curvilinear probe ( 2.5 to7.5HZ ) and a 23-gauge Quincke’s needle will be used. Upon positioning patients in a lateral position, the T8 spinous process identifed on the midline of the spine using a curvilinear probe. Subsequently, the ultrasound probe will be moved 2–3 cm laterally to locate the hyper echogenicity of the T8 transverse process and identify the erector spinae muscle. Using an in-plane technique,a 23-GZ needle will be advanced in a cranio-caudal direction until the tip of the needle reached the tip of the T8 transverse process. The correct position of the needle tip will be confirmed by hydrodissection of the interfascial plane . Under ultrasound guidance, a solution comprising 10 ml of 2% lidocaine,10 ml of 0.5% bupivacaine will be given and the spread of local anesthetics between the transverse processes and the erector spinae muscle will be observed in real time. Then hemodynamic response monitored during incision and ever15 minutes itraoperatively. |
| Intervention |
QUADRATUS LAMBORUM BLOCK |
Quadratus lumborum block: Patients will be positioned in lateral decubitus position with operative side up. pQLB(QL2) will be performed under direct visualization using a curvilinear ultrasound probe. Probe will be placed in transverse orientation at midaxillary line and sliding it posteriorly, fascial plane between the posterior aspect of the QL muscle and the middle layer of the thoracolumbar fascia will be identified, Quincke’s 23G needle will be inserted in plane from anterior to posterior, a solution comprising 10 ml of 2% lidocaine and 10 ml of 0.5% bupivacaine will be injected toward posterior surface of QL muscle and the spread of local anesthetic will be observed in real time. Then hemodyhamic response is monitored during incision and every 15 minutes intraoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1-3, undergoing elective laproscopic or robotic nephrectomy
Willing to participate
|
|
| ExclusionCriteria |
| Details |
1.Allergy to local anesthetics.
2. BMI more than 35 kg/m2
3. History of mental illness or taking psychotropic drugs.
4. Long-term use of analgesics or sedatives.
5. History of drug abuse, alcohol, or opioid abuse.
6. Chronic pain or recent acute pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare intraop opiod consumption after usg guided quadratus lamborum block(QLB) and erector spinae block(ESB) in minimally invasive nephrectomy. |
Baseline,at time of intubation, time of incision, then every 5 min intraop |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o To assess the quality of recovery in postop period
o To evaluate the requirement of rescue analgesia
o To assess complications (hypotension, bradycardia, nausea& vomiting)
|
24 hours postoperative period |
|
|
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)
|
01/12/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effective pain control is an essential component of enhanced recovery after surgery, particularly in minimally invasive nephrectomy. Although laparoscopic and robotic techniques reduce surgical trauma, patients may still experience significant postoperative pain that can delay recovery and increase opioid requirements. Opioid-based analgesia, while effective, is associated with adverse effects such as nausea, vomiting, respiratory depression, and delayed mobilization, all of which can impair the quality of recovery. In recent years, ultrasound-guided regional anesthesia techniques such as the Quadratus Lumborum Block (QLB) and the Erector Spinae Plane Block (ESPB) have emerged as promising alternatives for postoperative analgesia. Both techniques provide effective pain relief by blocking somatic and visceral pain pathways, but their relative efficacy and impact on opioid consumption and overall recovery after minimally invasive nephrectomy remain uncertain. This prospective randomized comparative study aims to evaluate and compare the opioid-sparing effects and quality of recovery between ultrasound-guided Quadratus Lumborum Block and Erector Spinae Plane Block in patients undergoing minimally invasive nephrectomy. By identifying the more effective technique, the study seeks to contribute to improved postoperative pain management, faster recovery, and enhanced patient satisfaction while minimizing opioid-related complications. |