| CTRI Number |
CTRI/2025/03/081812 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| 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 the use of two techniques with deposition of medicine around quadratus lumborum and erector spinae muscle in providing pain relief in patients undergoing surgery for kidney stone removal. |
|
Scientific Title of Study
|
Efficacy of transmuscular quadratus lumborum block versus erector spinae plane block for providing analgesia in patients undergoing percutaneous nephrolithotomy under general anaesthesia – A randomized controlled trial |
| 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 Shruthi R |
| Designation |
Senior Resident |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
2nd Floor, OT Complex,
Department of Anaesthesiology,
St. Johns Medical College Hospital,
Sarjapur Road, Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9741872128 |
| Fax |
|
| Email |
shruthi.95r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruthi R |
| Designation |
Senior Resident |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
2nd Floor, OT Complex,
Department of Anaesthesiology,
St. Johns Medical College Hospital,
Sarjapur Road, Bengaluru
KARNATAKA
560034
India |
| Phone |
9741872128 |
| Fax |
|
| Email |
shruthi.95r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. M. Manjuladevi |
| Designation |
Professor |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
2nd Floor, OT Complex,
Department of Anaesthesiology
St. Johns Medical College, Sarjapur Road, Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9449059395 |
| Fax |
|
| Email |
drmanjula95@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St. Johns National Academy of Health Sciences
Sarjapur Road
Bangalore - 560034
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Shruthi R |
| Address |
2nd Floor, OT Complex,
Department of Anaesthesiology,
St. Johns Medical College Hospital,
Sarjapur Road, Bengaluru,
Karnataka, India
Pincode - 560034
|
| 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 Shruthi R |
St Johns Medical College, Bengaluru |
Room No: 4, 2nd Floor, Operation Theatre Complex, St Johns Medical College Hospital, Sarjapur Road, Koramangala, Bangalore - 560034
Bangalore
KARNATAKA |
9741872128
shruthi.95r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St Johns Medical College and Hospital |
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 |
| Comparator Agent |
Erector Spinae Plane Block |
After administration of general anaesthesia, in prone position, the T11 vertebra will be identified by counting upwards from the L3-L4 interspace at the Tuffier’s line (highest point of the iliac crest). A low- or high-frequency linear probe will be placed in the midline in the longitudinal orientation. The transverse process of T11 will be identified by sliding the probe laterally, 3-4 cm away from the midline. A B. Braun Stimuplex Ultra 360° 100 mm needle will be inserted in-plane and advanced until the tip comes in contact with the lateral edge of the transverse process. The goal is to place the local anaesthetic between the transverse process and the erector spinae muscle overlying it. 30 ml of 0.25% Bupivacaine with 8mg Dexamethasone will be injected at in small aliquots after confirming negative aspiration for blood. The spread of the drug will be visualised as it lifts the erector spinae muscle off the bony shadow of the transverse process.
|
| Intervention |
Transmuscular Quadratus Lumborum Block |
After administration of general anaesthesia, in prone position, a low-frequency curvilinear USG probe will be placed in the transverse plane just above the iliac crest at the posterior axillary line, corresponding to the transverse process of L4 vertebra. The ‘Shamrock sign’ will be identified. Under USG guidance, a B. Braun Stimuplex Ultra 360° 100 mm needle will be inserted in-plane and allowed to traverse through the quadratus lumborum (QL) muscle until the tip pierces the epimysium of the muscle and lies in the interspace between the QL muscle and the psoas major along with the transversalis fascia. 30 ml of 0.25% Bupivacaine with 8mg Dexamethasone will be injected at this point in small aliquots after confirming negative aspiration for blood.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
89.00 Year(s) |
| Gender |
Both |
| Details |
1) Adult patients aged 18 to 89 years posted for unilateral percutaneous nephrolithotomy under general anaesthesia.
2) Patients belonging to ASA I to III physical status.
|
|
| ExclusionCriteria |
| Details |
1) Pregnant women
2) Patients with coagulopathies, thrombocytopenia
3) Infection at proposed site of infection
4) Hypersensitivity or known allergy to local anaesthetics
5) Patients with musculoskeletal deformities of the spine
6) Patients with psychiatric illness or cognitive dysfunction
7) Patients with uncontrolled hypertension
8) Patients on beta blockers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the duration of analgesia provided by both techniques |
Duration of analgesia measured starting from the time of block administration in the operation theatre till the first analgesic demand by the patient in the postoperative period in the ward, measured in minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative haemodynamic responses to pain and surgical stimulation – Heart rate (beats per minute), systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg) and mean arterial pressure (mm Hg). |
Intraoperative period |
| Numeric Rating Scale to assess severity of pain. |
6, 12, 24 and 48 hours post operatively |
| Number of rescue boluses of Inj. Pethidine in the first 24 hours after surgery and total dose (mg) provided during hospital stay in 24 hours. |
24 hour period after surgery |
| iv. Side effects – hypotension, bradycardia, itching, drowsiness, nausea and vomiting. |
24 hour period after suregry |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/03/2025 |
| 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
|
Percutaneous Nephrolithotomy (PCNL) is currently one of the most efficient and commonly performed urological procedures and is the gold-standard treatment modality for large renal stones. Despite limiting the size of the skin incision, the use of continuous irrigation causing pelvicalyceal dilatation and the insertion of a nephrostomy tube can result in severe postoperative pain for the patient which further contributes to restricted ambulation, prolonged recovery and a longer hospital stay. Given the frequency at which the surgical procedure is being performed, it is essential that we investigate and identify the best possible method of providing analgesia for these patients. Regional anaesthesia provides many benefits including ease of performance, remarkable safety profile and decreased opioid consumption. The gold standard approaches to pain management in PCNL surgeries are epidural analgesia and thoracic paravertebral blocks, however the technically complexicity and associated complications have lead to the emergence of simpler and effective regional blocks. Literature review has revealed that the transmuscular quadratus lumborum block (TQLB) and the erector spinae plane block (ESPB) have shown much promise when compared to other regional techniques or the use of opioid analgesia. However, there has never been a published study comparing the efficacy of these two regional approaches for PCNL surgery. With this study we aim to compare the analgesic efficacy of TQLB and ESPB in patients undergoing PCNL surgery. |