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Post Operative PainPhase 2/3NCT06568770

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

A Phase 2/3 study testing USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK and PERICAPSULAR NERVE BLOCK in people with Post Operative Pain and Bradycardia, run by Sahiwal medical college sahiwal at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Post Operative Pain, Bradycardia, Hypotension
What is being tested?
USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK and PERICAPSULAR NERVE BLOCK
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 sitePakistan
Study dates
10 Jul 2024to 10 Jan 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr Shajeea Asghar, MBBS contact

00923217731060

shajeea55.sa@gmail.com

Dr Muhammad Shahid, FCPS contact

00923336173056

shahidnishtar@gmail.com

Pakistan1 site, 1 recruiting
  • Sahiwal Medical College

    Sahiwal, Punjab Province, 57000

    Dr Rao Riaz ul-Haq, FCPS, 040-4502470, slmcswl@gmail.com

    Dr Shajeea Asghar, MBBS

    Recruiting

Other trials in Pakistan

About this study

Official title: Comparison of Ease of SPINAL Positioning Between USG Guided Supra-inguinal Fascia Iliaca Block vs USG Guided Pericapsular Nerve Group Block in Patients Undergoing Femur Fracture Surgery

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.

Read the detailed description

Patients fulfilling the inclusion criteria will be included. Patients will be optimized for dressing. A detailed history will be taken regarding the mode of injury, any pre-existing disease and previous surgery followed by the local examination of the patient will be done to rule out any systemic disease. Informed consent will be taken. These patients will be divided into 2 groups by Computer-generated random numbers and group assignment will be done by sequentially numbered opaque envelopes. The envelope will be opened just before the procedure by the anaesthesiologist performing the block. The observer (another anaesthesiologist) and patients will be unaware of the group and procedure performed. Group A (Supra-inguinal Fascia Iliaca Block) and Group B (Pericapsular Nerve Group Block). The monitors of electrocardiogram, pulse oximetry and non-invasive blood pressure in the preoperative area will be connected. For drug and fluid administration, an intravenous cannula of suitable size will be obtained. Pre-procedural pain will be assessed during rest as well as on movement (15° passive elevation) of the affected limb and will be recorded on numeric pain rating scale (NRS) [0 = no pain; 10 = worst imaginable pain]. The blocks will be performed in supine position and strict sterile technique will be followed. Both the blocks will be performed as per the standard technique. The site to be blocked will be painted with 5% povidone-iodine followed by spirit and will be draped. A linear 7-13 MHz ultrasonography probe (ACUSON P500, digital colour doppler ultrasound, Siemens Germany) will be used with in-plane approach of needle. Group S-FIB (n = 35, those who will receive a S-FIB with 20 mL of 0.5% bupivacaine) and group PENG (n = 35, those who will receive a PENG with 20 mL of 0.5% bupivacaine). Depending on the allotted group, patients will be given the block under the guidance of ultrasound in the preoperative area by an experienced anesthesiologist with more than two years' experience. The PENG block will be performed as follows: 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. The S-FIB will be given in a similar fashion. 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. A numerical rating scale (NRS) pain score will be recorded before the block. The onset time to achieve NRS pain score of 4 or less than 4 will be noted on prescribed proforma for both groups. The patients will be made to sit for spinal anesthesia when the NRS score will be less than 4 after preloading with ringer lactate solution @80ml/kg. The spinal anaesthesia will be performed using 25G spinal needle () with 0.75% bupivacaine solution (2ml) in both groups. The monitors of electrocardiogram, pulse oximetry, non-invasive blood pressure and urine output will be monitored according to ASA standard. After completion of surgery patient will be shifted to respective ward where trained doctor and staff will monitor the patient. The NRS score will be measured immediately postoperatively and at intervals of 2 hours for a period of 24 hours. If the NRS score will be > 4, rescue analgesia will be given; an injection of paracetamol 15 mg/kg will be given over a period of 10 to 15 minutes as an intravenous infusion and time will be noted. Inj nalbuphine 0.1mg/kg will be given for breakthrough pain. Total dose of intravenous nalbuphine will be recorded in 1st 24hrs.

Being tested
USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK, PERICAPSULAR NERVE BLOCK
Keywords
PENG,S-FICB,ASA,EOSP
Medical subject headings
Pain, Postoperative, Bradycardia, Hypotension, Femoral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCKDrug

    Also called S-FICB

    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

  • PERICAPSULAR NERVE BLOCKDrug

    Also called PENG

    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.

Study groups in NCT06568770
Study groupRoleWhat they receive
GROUP S-FICBOtherSuprainguinal Facia iliaca Block
Receives: Drug: USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK
GROUP-PENGOtherPericapsular Nerve Group Block
Receives: Drug: PERICAPSULAR NERVE BLOCK

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 20 minutes till Performance of spinal anaesthesia

Secondary outcomes (2)
  1. Post op Analgesia

    Duration of post op analgesia.

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

  2. opioid sparing effect

    total opioid consumption in mg/24hrs

    Measured: 24 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2024
  2. Study start10 Jul 2024
  3. Primary completion10 Nov 2025 (estimated)
  4. Study completion10 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group 1 will receive S-FICB and Group 2 will receive PENG
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06568770
Sponsor's protocol ID
211/IRB
Status last verified
Oct 2025
First submitted
13 Aug 2024
Last updated
23 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data will be available on request after completion of study i.e. March 2025.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK and PERICAPSULAR NERVE BLOCK in people with Post Operative Pain and Bradycardia, run by Sahiwal medical college sahiwal at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr Shajeea Asghar, MBBS (00923217731060, shajeea55.sa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ease Of Spinal Positioning (time frame: 20 minutes till Performance of spinal anaesthesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.

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