CTRI Number |
CTRI/2023/03/050911 [Registered on: 21/03/2023] Trial Registered Prospectively |
Last Modified On: |
17/03/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two approaches of sciatic nerve block via ultrasound guidance |
Scientific Title of Study
|
Ultrasound-guided supine popliteal sciatic nerve block: Crosswise approach to popliteal sciatic (CAPS) versus Posterior approach |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Varun Singla |
Designation |
Assistant Professor |
Affiliation |
PGIMER Chandigarh |
Address |
Anesthesia Office, OT complex, 4th floor, Nehru Block, PGIMER Chandigarh. 160012
Chandigarh CHANDIGARH 160012 India |
Phone |
8427474087 |
Fax |
|
Email |
drvarunsinglapgi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Varun Singla |
Designation |
Assistant Professor |
Affiliation |
PGIMER Chandigarh |
Address |
Anesthesia Office, OT complex, 4th floor, Nehru Block, PGIMER Chandigarh. 160012
Chandigarh CHANDIGARH 160012 India |
Phone |
8427474087 |
Fax |
|
Email |
drvarunsinglapgi@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Varun Singla |
Designation |
Assistant Professor |
Affiliation |
PGIMER Chandigarh |
Address |
Anesthesia Office, OT complex, 4th floor, Nehru Block, PGIMER Chandigarh. 160012
Chandigarh CHANDIGARH 160012 India |
Phone |
8427474087 |
Fax |
|
Email |
drvarunsinglapgi@gmail.com |
|
Source of Monetary or Material Support
|
Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh |
|
Primary Sponsor
|
Name |
PGIMER Chandigarh |
Address |
Anaesthesia Office, OT complex, 4th floor, Nehru Block, PGIMER Chandigarh 160012 |
Type of Sponsor |
Research institution |
|
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 Varun Singla |
PGIMER Chandigarh |
Anaesthesia Office, OT complex, 4th floor, Nehru block, PGIMER Chandigarh 160012 Chandigarh CHANDIGARH |
8427474087
drvarunsinglapgi@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Instt Ethics Committee (Intramural) PGIMER Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S82||Fracture of lower leg, including ankle, (2) ICD-10 Condition: S92||Fracture of foot and toe, except ankle, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Group I (PSNB Group): Patients will be given USG-guided Popliteal sciatic nerve block using 20ml of 0.5% Bupivacaine |
Administration of combined sciatic and saphenous nerve block
B) Sciatic nerve Block
Posterior approach: The PSNB technique will be performed using a linear or curvilinear USG transducer placed in the transverse position at the popliteal crease with knee and hip of the patient flexed to allow for USG placement, and then the popliteal artery and vein will be identified. The biceps femoris muscle will be observed lateral to the popliteal artery, and the semimembranosus and semitendinosus muscles will be identified in the medial plane. The tibial nerve will be seen as a hyperechoic, rounded structure lateral to the popliteal vein. The common peroneal nerve will be visible lateral to the tibial nerve. The transducer will be advanced proximally until the tibial and peroneal nerves come together to form the sciatic nerve. A 10-cm, 22-G Stimuplex needle (B. Braun Medical Ltd., Melsungen, Germany) will be inserted below the midpoint of transducer using an out-of-plane approach. The needle tip will be placed into the space between the two components of the sciatic nerve slightly separated by adipose tissue at the point of division. 20ml of 0.5 % bupivacaine will be injected and perineural spread will be noted in real time under USG.5
Patient’s limb will be made supine just after injection of drug as leg-up position for sciatic nerve block may lead to a more proximal distribution of the local anesthetic and may result in a faster onset of sensory and motor blocks as well as longer duration of blockade.6
|
Intervention |
Group II (CAPS Group): Patients will be given USG-guided CAPS (Crosswise approach to popliteal sciatic) block using 20ml of 0.5% Bupivacaine |
CAPS:
Linear or curvilinear USG probe will be placed in the transverse plane over the lateral aspect of the thigh at or below the intermuscular groove formed by vastus medialis and biceps femoris muscle. The limb position will be facilitated by placing a folded towel or foam leg elevator underneath the calf muscles to help in probe placement. The probe will be moved in cephalad direction from the lateral aspect of popliteal fossa to identify the hyperechoic sciatic nerve between the hypoechoic biceps femoris, semitendonsus and semimembranosus. A 10-cm, 22-G Stimuplex needle (B. Braun Medical Ltd., Melsungen, Germany) will be inserted perpendicular to the skin using an out-of-plane approach in lateral to medial direction. The needle tip will be placed into the space between the two components of the sciatic nerve. 20 ml of 0.5% bupivacaine will be injected and perineural spread will be noted.2
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Patients between age group 18-80 years undergoing below knee surgeries, ASA physical status I-III
|
|
ExclusionCriteria |
Details |
Patient refusal for nerve blocks, Allergy to amide local anaesthetic drugs, Chronic opioid therapy (>60 mg morphine daily or equivalent), Patients with thrombocytopenia/coagulopathy, on anti-coagulant and thrombolytic therapy, Morbid obesity (BMI>35 with obesity symptoms or BMI > 40), Neurological diseases, Local or systemic infection, Patients with psychiatric illness
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Time to perform the block |
(time interval from the contact of USG probe with the patient to the end of local anaesthetic injection) |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Block onset time |
time interval from the end of local anaesthetic injection to the achievement of complete sensory blockade of both saphenous and sciatic nerve |
2. Number of needle passes |
During performance of procedure |
3. Level of procedure related pain |
During performance of procedure |
4. Sciatic nerve visibility score and depth from skin |
During performance of procedure |
5. Visual analog scale (VAS) scores |
immediate post-operation (T1), at 2 hours (T2), 4 hours (T3), 8 hours (T4), 12 hours (T5), 16 hours (T6), 24 hours (T7), and 48 hours (T8) |
6. Time to first rescue analgesia |
during 48 hr follow up |
7. 48 hour rescue analgesic consumption |
during 48 hr follow up |
8. Occurrence of any adverse events/complications |
during 48 hr follow up |
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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
|
Phase 3 |
Date of First Enrollment (India)
|
01/04/2023 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Popliteal sciatic nerve
block (PSNB) is commonly practised regional anaesthesia and analgesia technique
for below-knee surgeries. It is used alone or combined with a femoral or
saphenous nerve block. The block can be performed blindly, guided by a nerve
stimulator or ultrasound. The blind landmark-based technique is not preferred
due to lower efficacy and higher complication rates.1 The use of
ultrasound (USG) allows a real-time visualisation and delivery of the
medication at the target site, improving precision, accuracy and safety. The
nerve block can be performed in the posterior, lateral and supine positions.
Lateral and prone may pose challenges in morbidly obese, pregnant, hemodynamically
unstable and/or spinal injury patients.2 In supine
position, the popliteal sciatic block can be performed by the posterior
approach with out-of-plane needle entry, lateral or medial approach with
lateral or medial in-plane needle entry respectively. The supine posterior
out-of-plane approach provides the advantage of patient comfort, less chance of
puncturing the popliteal vessels and shorter needle path.3, 4
Recently, Mistry et al
have described an USG-guided CAPS (Crosswise approach to popliteal sciatic)
block in a case series of 5 patients successfully with the advantage of better
patient comfort as there is no need of patient positioning, flexion of hip and
knees and external assistance.2
We aim to compare the
USG-guided posterior approach of popliteal sciatic block and CAPS block. |