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Post Operative AnalgesiaPhase 2/327GNCT07221682

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

A Phase 2/3 study testing USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK and USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK in people with Post Operative Analgesia 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

Severe pain associated with thigh and knee fractures makes the positioning for regional anesthesia a challenge. Different modalities to make patient pain free for spinal positioning, post op analgesia and patient satisfaction including supra-inguinal fascia iliaca block (S-FIB) and infra-inguinal fascia iliaca blocks… Read more about this study

Who is it for?
Ages 30 to 60 years
What is being tested?
USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK and USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
6 May 2024to 1 Jan 2027
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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both Genders (Male /Female).
  • Age between 30 years to 60 years.
  • 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
  • Patients with significant cognitive impairment
  • Patients with no pain while sitting by themselves without any support
  • H/O polytrauma involving other limbs
  • H/O allergy to the drugs used in study

Trial locations and contacts

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

Dr Humaira Shahzadi, MBBS contact

00923044128425

humairaali2323@gmail.com

Dr Muhammad Shahid, FCPS contact

00923336173056

shahidnishtar@gmail.com

Pakistan1 site, 1 recruiting
  • Sahiwal Medical College Sahwal

    Sāhīwāl, Punjab Province, 57000

    Dr Rao Riaz ul-Haq, FCPS, 0092404502470, slmcswl@gmail.com

    Dr Humaira Shahzadi, MBBS

    Recruiting

Other trials in Pakistan

About this study

Official title: Comparison For Ease Of Spinal Positioning & Duration Of Post-Op Analgesia Between Ultrasound Guided Supra-Inguinal Fascia Iliaca Block Vs Ultrasound Guided Infra-Inguinal Fascia Iliaca Block In Patients Undergoing Thigh & Knee Surgeries

Severe pain associated with thigh and knee fractures makes the positioning for regional anesthesia a challenge. Different modalities to make patient pain free for spinal positioning, post op analgesia and patient satisfaction including supra-inguinal fascia iliaca block (S-FIB) and infra-inguinal fascia iliaca blocks (I-FIB) have been studies. The aim of this study is to compare two blocks in patients undergoing thigh and knee surgeries.

A randomized controlled trial study design will be used and 60 patients fulfilling the inclusion criteria will be included. The patients will be divided into 2 groups by simple random sampling. Group A (S-FIB) (n = 30, those who will receive 30 ml of 0.125% bupivacaine) and Group B (I-FIB) (n = 30, those who will receive 30 ml of 0.125% bupivacaine). Depending on the allotted group, patients will be given the block under the guidance of ultrasound in the preoperative area. After block patients will be assessed for ease of spinal positioning using EOSP Scale, postoperative duration of analgesia and patient satisfaction using Likert Scale and data will be recorded on prescribed proforma.

All the findings will be noted in a specially designed proforma by the researcher. All the data collected will be entered and analyzed. Quantitative variables will be presented with mean ± SD. Independent sample t-test for duration of postoperative analgesia. Qualitative variables such as ease of spinal positioning and gender will be presented with Chi-Square. A p-value equal to or less than 0.05 will be considered significant.

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 (Infra-inguinal Fascia Iliaca Block). The monitors of electrocardiogram, pulse oximetry and non-invasive blood pressure in induction room 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 (sonoscape S 11plus, digital colour doppler ultrasound., Guangdong, China) will be used with in-plane approach of needle. Group A (S-FIB) (n = 30, those who will receive a S-FIB with 30 ml of 0.125% bupivacaine) and group B (I-FIB) (n = 30, those who will receive a I-FIB with 30 ml of 0.125% 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 S-FIB will be given as follows: 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. The needle entry point will be anaesthetized with 2 ml 1% lidocaine and 23G spinal needle will be inserted. After negative aspiration, 1-2 ml of Inj Bupivacain 0.125% 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.

The I-FIB will be given in similar manner. In ultrasound guided I-FIB technique, a high frequency linear probe will be placed transversely at the level of the inguinal crease. After the femoral artery is identified, the probe will be moved laterally, and the hypoechoic iliopsoas muscle will be identified which is covered by the hyperechoic fascia iliaca. This fascia invests the femoral nerve medially and laterally covers the sartorius muscle. A needle will be inserted in-plane from lateral to medial and pierces the fascia iliaca at the junction of medial border of sartorius and iliopsoas muscle. Then Inj Bupivacain 0.125% will be deposited deep to fascia iliaca and will be seen spreading toward the femoral nerve medially.

A numerical rating scale (NRS) pain score will be recorded after 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 and ease of spinal positioning according to the scale (0,1,2,3) , will be noted after preloading with ringer lactate solution @80ml/kg. The spinal anaesthesia will be performed using 27G spinal needle (Quincke) 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 12 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. Inj nalbuphine 0.1mg/kg will be given for breakthrough pain. Total dose of intravenous nalbuphine will be recorded in 1st 12hrs. Patient satisfaction will be measured on a 1-5 Likert Scale after 12 hours.

Being tested
USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK, USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK
Keywords
S-FICB, I-FICB, ASA, EOSP
Medical subject headings
Bradycardia, Hypotension

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 Sifi-B

    The S-FICB will be given as follows: 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. The needle entry point will be anaesthetized with 2 ml 1% lidocaine and 23G spinal needle will be inserted. After negative aspiration, 1-2 mL of Inj Bupivacain 0.125% 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.

  • USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCKDrug

    Also called Iifi-B

    The I-FICB will be given in similar manner. In ultrasound guided I-FICB technique, a high frequency linear probe will be placed transversely at the level of the inguinal crease. After the femoral artery is identified, the probe will be moved laterally, and the hypoechoic iliopsoas muscle will be identified which is covered by the hyperechoic fascia iliaca. This fascia invests the femoral nerve medially and laterally covers the sartorius muscle. A needle will be inserted in-plane from lateral to medial and pierces the fascia iliaca at the junction of medial border of sartorius and iliopsoas muscle. Then Inj Bupivacain 0.125% will be deposited deep to fascia iliaca and will be seen spreading toward the femoral nerve medially.

Study groups in NCT07221682
Study groupRoleWhat they receive
GROUP S-FICBOtherSuprainguinal Facia Iliaca Block
Receives: Drug: USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK
GROUP I-FICBOtherInfrainguinal Facia Iliaca Block
Receives: Drug: USG GUIDED INFRA-INGUINAL FASCIA ILIACA 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: From performance of block to spinal anesthesia procedure begins

Secondary outcomes (1)
  1. Post Op Analgesia

    Duration of Post Op Analgesia

    Measured: From Performance of Block to First Rescue Analgesia e.g. at 0,2,4,6 upto 12 hours

Timeline

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

  1. First posted28 Oct 2025
  2. Study start6 May 2024
  3. Primary completion25 Oct 2026 (estimated)
  4. Study completion1 Jan 2027 (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 I-FICB
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07221682
Sponsor's protocol ID
202/IRB/SLMC/SWL
Acronym
27G
Status last verified
Oct 2025
First submitted
21 Oct 2025
Last updated
29 Jan 2026
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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK and USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK in people with Post Operative Analgesia 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 3 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 29 Jan 2026. 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 Humaira Shahzadi, MBBS (00923044128425, humairaali2323@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: From performance of block to spinal anesthesia procedure begins). 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 29 Jan 2026.

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