Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery

NCT06568770 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 211/IRB
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the immediate and postoperative analgesic efficacy of S-FICB and PENG block will be the objective. The use of ultrasonography in anesthesia has helped the anesthetist to see the nerve, needle and the distribution of the drug, thereby enhancing the chances of a favorable outcome of the nerve block. Grade A recommendation for an ultrasound guided approach to the peripheral nerve blocks is supported by level Ib evidence for a shortened time for the onset of sensory block, decreased performance time and lower drug doses10. Although individually both the blocks have been studied, there are only a handful of studies comparing both techniques under ultrasound guidance for making patient positioning for spinal anesthesia easy. And no local data is available comparing these blocks. So, we want to compare the analgesic efficacy of USG PENG block with USG S-FICB block in patients with fracture femur in reducing pain associated with positioning (sitting) for subarachnoid block, duration of analgesia, opioid sparing effect and complications. So that procedure with better analgesic efficacy and less complications will be included in our local guidelines as a part of multimodal analgesia.

Conditions

Post Operative Pain; Bradycardia; Hypotension; Femur Fracture

Keywords

PENG,S-FICB,ASA,EOSP

Outcome Measures

Primary Outcomes (1)

• Ease Of Spinal Positioning

  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

  20 minutes till Performance of spinal anaesthesia

Secondary Outcomes (2)

• Post op Analgesia

  from performance of block to first rescue analgesia(in hours)

• opioid sparing effect

  24 hrs

Other Outcomes (1)

• Post op Nausea Vomiting

  24 hrs

Study Arms (2)

GROUP S-FICB

OTHER

Suprainguinal Facia iliaca Block

Drug: USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK

GROUP-PENG

OTHER

Pericapsular Nerve Group Block

Drug: PERICAPSULAR NERVE BLOCK

Interventions

USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK DRUG

With the patient in the proper position, the skin will be disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer will be moved laterally until the sartorius muscle is identified. As the needle will eventually pierce the fascia, maybe a "pop" will be felt. After negative aspiration, 1-2 mL of local anesthetic will be injected to confirm the proper injection plane between the fascia and the ilio-psoas muscle. A proper injection will result in the separation of the fascia iliaca by the local anesthetic in the medial-lateral direction from the point of injection as described. After the spread of the drug will be seen, the rest of the drug volume will be injected

Also known as: S-FICB

GROUP S-FICB

PERICAPSULAR NERVE BLOCK DRUG

an ultrasound probe will be placed over the line joining anterior superior iliac spine (ASIS) and pubic tubercle (PT) keeping lateral margin at ASIS and adjusted the probe to get a sonoanatomic view for PENG block. The needle entry point will be selected on the skin in such a manner that perpendicular needle entry will guide needle near target point iliopectineal eminence (IPE). The needle entry point will be anaesthetized with 2 ml 1% lidocaine and 22G 80mm stimuplex needle will be inserted "out-of- plane" to reach the bony rim near IPE avoiding injury to femoral nerve (visible just lateral to femoral artery). On bony contact, 20 ml 0.5% bupivacaine will be injected slowly with repeated aspiration to avoid intravascular injection. The correct needle position will be confirmed by drug spread under ilio-psoas muscle and then the rest of the drug volume will be injected.

Also known as: PENG

GROUP-PENG

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Both Genders (Male /Female). 2. Age between 20 years to 70 years. 3. Radiologically confirmed femur fracture. 4. ASA Class I, II, III.

You may not qualify if:

• Patient refusal
• Other distracting painful pathology
• Any contraindication to Spinal Anesthesia or peripheral nerve blocks
• Coagulopathic disorders
• H/O ischemic heart disease
• Patients on opioids for chronic pain
• Patients with significant cognitive impairment
• Patients with no pain while sitting by themselves without any support.

Sponsors & Collaborators

• Sahiwal medical college sahiwal: lead

Study Sites (1)

Sahiwal Medical College

Sahiwal, Punjab Province, 57000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Bradycardia; Hypotension; Femoral Fractures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Adeel Riaz, MD

  Sahiwal medical college sahiwal

  STUDY DIRECTOR

Central Study Contacts

Dr Shajeea Asghar, MBBS

CONTACT

00923217731060; shajeea55.sa@gmail.com

Dr Muhammad Shahid, FCPS

CONTACT

00923336173056; shahidnishtar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Anaesthetist

Model Details: Group 1 will receive S-FICB and Group 2 will receive PENG

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 23, 2024
• Study Start: July 10, 2024
• Primary Completion: November 10, 2025
• Study Completion: January 10, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: March 2025
• Access Criteria: On Demand

Locations

PA (1)