| CTRI Number |
CTRI/2024/04/065003 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| 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
|
Comparison of Ultrasound-guided combined Nerve Group blocks and single nerve group block as perioperative pain relief in patients posted for hip surgeries under Spinal Anesthesia – Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparison of Ultrasound-guided Pericapsular Nerve Group Block with and without Supra inguinal Fascia Iliaca Compartment Block as perioperative analgesia in patients posted for hip surgeries under Spinal Anesthesia – 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 |
Divya Bhatkar |
| Designation |
Post graduate resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Anesthesiology and Critical Care, AIIMS Bathinda, Mandi Dabwali road, Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
8425859163 |
| Fax |
|
| Email |
dpbhatkar98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anju Grewal |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Anesthesiology and Critical Care, AIIMS Bathinda, Mandi Dabwali road, Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
9815482626 |
| Fax |
|
| Email |
dranjugrewal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gopal Krishan Jalwal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Anesthesiology and Critical Care, AIIMS Bathinda, Mandi Dabwali road, Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
7838939833 |
| Fax |
|
| Email |
gopaljalwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Bathinda
Mandi Dabwali Road,
Bathinda,
Punjab-151001
India |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Bathinda |
| Address |
All India Institute Of Medical Sciences Bathinda, Mandi Dabwali road, Bathinda, Punjab, Pin code- 151001. |
| 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 Divya Bhatkar |
All India Institute Of Medical Sciences, Bathinda |
Room no 145, Department of Anesthesiology and Critical Care,
All India Institute Of Medical Sciences Bathinda, Mandi Dabwali road, Bathinda, Punjab, Pin code- 151001. Bathinda PUNJAB |
8425859163
dpbhatkar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute Of Medical Sciences, Bathinda Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W010||Fall on same level from slipping,tripping and stumbling without subsequent striking against object, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A patients will receive Ultrasound-guided PENG block and SIFICB in the preoperative room in supine position. |
Technique of PENG block
The patient will be positioned supine. The block will be performed under absolute aseptic precautions using a low-frequency Ultrasound probe with an echogenic peripheral nerve block needle (Stimuplex Ultra). In order to perform the block, the low-frequency probe of the Ultrasound machine (Sonosite Fujifilm Inc. USA) will be positioned parallel to the inguinal ligament at the level of the anterior superior iliac spine (ASIS), and scanning will proceed with a gradual movement of the probe caudally, keeping the probe parallel to the inguinal ligament. When the lower anterior inferior iliac spine (AIIS) is visible, the probe will be moved medially in such a way that a continuous hyperechoic shadow of the upper pubic ramus is seen. This method will identify the iliopsoas muscle, which has a conspicuous tendon immediately above the pubic ramus. The target plane to deposit local anaesthetic is between the pubic ramus and iliopsoas tendon (hyperechoic structure just above the pubic ramus). Using the in-plane approach, the 22G, 10 cm long, echogenic needle will be advanced in the musculofascial plane between the psoas tendon and the pubic ramus, lateral to the medial side. Hydro dissection and spread under the illo-psoas muscle will reveal the needles precise site and 20ml of 0.2% ropivacaine will be injected.(14)
Technique of SIFICB - This block will be accomplished with a high-frequency linear ultrasonic transducer probe (Fujifilm sonosite USA) under aseptic precautions. The patient will be positioned supine to perform the block. The probe will be positioned in the para-sagittal plane over the inguinal ligament near the anterior superior iliac spine. The thick white line of the ilium will first be detected, followed by the more superficial, black (hypoechogenic) iliacus muscle with the fascia iliaca covering its surface then the probe will be moved inferior and medially until you visualise the anterior inferior iliac spine and bow tie sign (confluence of oblique muscle one side and sartorius on another side over the fascia iliaca). The deep circumflex iliac artery, which gives a landmark for needle placement, can be located superficial to the fascia iliaca 1-2 cm superior to the inguinal ligament. The needle (Stimuplex ultra) will be inserted through the in-plane technique (caudal to cranial), and will be moved through the fascia iliaca at the inguinal ligament level. The needle frequently makes a pop when it traverses through the fascia iliaca and enters the iliacus muscle . Through the process of hydro-dissection, the needle will be advanced superiorly, deep into the fascia iliaca. The local anaesthetic must be able to spread across the surface of the iliacus muscle freely. When the local anaesthetic freely travels superiorly across the iliacus muscle, and into the iliac fossa, the endpoint will be achieved. At this site, a total of 20 mL of ropivacaine 0.2% will be administered.(3) |
| Comparator Agent |
Group B patients will receive Ultrasound guided PENG block alone in the preoperative room in supine position. |
Technique of PENG block
The patient will be positioned supine. The block will be performed under absolute aseptic precautions using a low-frequency Ultrasound probe with an echogenic peripheral nerve block needle (Stimuplex Ultra). In order to perform the block, the low-frequency probe of the Ultrasound machine (Sonosite Fujifilm Inc. USA) will be positioned parallel to the inguinal ligament at the level of the anterior superior iliac spine (ASIS), and scanning will proceed with a gradual movement of the probe caudally, keeping the probe parallel to the inguinal ligament. When the lower anterior inferior iliac spine (AIIS) is visible, the probe will be moved medially in such a way that a continuous hyperechoic shadow of the upper pubic ramus is seen. This method will identify the iliopsoas muscle, which has a conspicuous tendon immediately above the pubic ramus. The target plane to deposit local anaesthetic is between the pubic ramus and iliopsoas tendon (hyperechoic structure just above the pubic ramus). Using the in-plane approach, the 22G, 10 cm long, echogenic needle will be advanced in the musculofascial plane between the psoas tendon and the pubic ramus, lateral to the medial side. Hydro dissection and spread under the illo-psoas muscle will reveal the needles precise site and 20ml of 0.2% ropivacaine will be injected.(14)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of age group 18-80 years
American Society of Anesthesiologists physical status I, II and III
Patients undergoing hip surgery under spinal anesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients with history of opioid usage
Patients with history of peripheral neuropathy
Patients with history of Neuromuscular disorders
Polytrauma patients or patients with other fractures
Patients with history of bleeding disorders
|
|
|
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 evaluate the time to first analgesic request post operatively in both the patient groups undergoing the respective blocks. |
We will assess pain levels using the Numeric Rating Scale (NRS) at rest and with 15° leg elevation in the PACU, as well as at 6, 12, 18, and 24 hours after the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To calculate Ease Of Spinal Positioning (EOSP) score after positioning for spinal anesthesia
2)To determine Numerical Rating Scale pain Scores at rest and at 15° leg elevation in both the groups undergoing the respective blocks.
3) To determine the total dose of analgesic requirement in the first 24hrs after surgery in both patient groups.
|
Assess pain levels using the Numeric Rating Scale (NRS) at rest and with 15° leg elevation in the PACU, as well as at 6, 12, 18, and 24 hours after the surgery. |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/04/2024 |
| Date of Study Completion (India) |
10/04/2025 |
| 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)
|
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
Modification(s)
|
In this prospective randomized study, the patients will be enrolled based on the inclusion and exclusion criteria. All the patients eligible for the study will undergo a preoperative assessment and will be explained thoroughly about the study. A detailed patient information sheet will be given to these selected patients. Written informed consent in vernacular language will be taken prior to the study from all the patients participating in the trial. The study will start once the patient arrives in the preoperative room. Preoperative instructions on how we will assess the perioperative pain using Numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain), will be explained to patients. Intra-venous access will be obtained before arrival in operation theatre. The preoperative Numerical Rating Scale pain scores at rest and at 15 ° leg elevation will be recorded. Under all aseptic precautions, Group A patients will receive Ultrasound-guided PENG block and SIFICB and Group B patients will receive Ultrasound guided PENG block alone in the preoperative room in supine position as described below. Technique of PENG block The patient will be positioned supine. The block will be performed under absolute aseptic precautions using a low-frequency Ultrasound probe with an echogenic peripheral nerve block needle (Stimuplex Ultra). In order to perform the block, the low-frequency probe of the Ultrasound machine (Sonosite Fujifilm Inc. USA) will be positioned parallel to the inguinal ligament at the level of the anterior superior iliac spine (ASIS), and scanning will proceed with a gradual movement of the probe caudally, keeping the probe parallel to the inguinal ligament. When the lower anterior inferior iliac spine (AIIS) is visible, the probe will be moved medially in such a way that a continuous hyperechoic shadow of the upper pubic ramus is seen. This method will identify the iliopsoas muscle, which has a conspicuous tendon immediately above the pubic ramus. The target plane to deposit local anaesthetic is between the pubic ramus and iliopsoas tendon (hyperechoic structure just above the pubic ramus). Using the in-plane approach, the 22G, 10 cm long, echogenic needle will be advanced in the musculofascial plane between the psoas tendon and the pubic ramus, lateral to the medial side. Hydro dissection and spread under the illo-psoas muscle will reveal the needle’s precise site and 20ml of 0.2% ropivacaine will be injected.(14)
Technique of SIFICB - This block will be accomplished with a high-frequency linear ultrasonic transducer probe (Fujifilm sonosite USA) under aseptic precautions. The patient will be positioned supine to perform the block. The probe will be positioned in the para-sagittal plane over the inguinal ligament near the anterior superior iliac spine. The thick white line of the ilium will first be detected, followed by the more superficial, black (hypoechogenic) iliacus muscle with the fascia iliaca covering its surface then the probe will be moved inferior and medially until you visualise the anterior inferior iliac spine and bow tie sign (confluence of oblique muscle one side and sartorius on another side over the fascia iliaca). The deep circumflex iliac artery, which gives a landmark for needle placement, can be located superficial to the fascia iliaca 1-2 cm superior to the inguinal ligament. The needle (Stimuplex ultra) will be inserted through the in-plane technique (caudal to cranial), and will be moved through the fascia iliaca at the inguinal ligament level. The needle frequently makes a ’pop’ when it traverses through the fascia iliaca and enters the iliacus muscle . Through the process of hydro-dissection, the needle will be advanced superiorly, deep into the fascia iliaca. The local anaesthetic must be able to spread across the surface of the iliacus muscle freely. When the local anaesthetic freely travels superiorly across the iliacus muscle, and into the iliac fossa, the endpoint will be achieved. At this site, a total of 20 mL of ropivacaine 0.2% will be administered.(3)
The NRS at rest and with 15° leg elevation will be measured 10 min later after the completion of both blocks. Standard ASA monitors will be attached electrocardiogram (ECG), pulse oximetry (SpO2), non-invasive blood pressure (NIBP); on their arrival in operation theatre. The Ease Of Spinal Positioning (EOSP) will be assessed on the scale of 0–3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself without pain).(11) Subarachnoid block will be performed with 15 mg bupivacaine (3 ml of a 0.5% solution) after confirming free flow of cerebrospinal fluid to achieve sensory block at or above T10 dermatome. Intraoperative fluids and blood will be administered according to the requirement. After the surgery, all patients will be transferred to the post-anesthesia care unit (PACU) and will be given a 1gm dose of intravenous paracetamol, followed by 8 hourly in the postoperative period. We will assess pain levels using the Numeric Rating Scale (NRS) at rest and with 15° leg elevation in the PACU, as well as at 6, 12, 18, and 24 hours after the surgery. If NRS >/=4 then inj fentanyl 25 mcg bolus will be given to the patients. Post operatively, we will monitor the patients hemodynamic parameters, NRS pain scores, duration of pain relief (the time from completing both procedures to the patient’s first dose of rescue pain relief) and the total analgesic consumption over 24hrs will be recorded.(3) |