NCT07221682 Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery
| NCT ID | NCT07221682 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sahiwal medical college sahiwal |
| Condition | Post Operative Analgesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2026-10-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-05-06 with a primary completion date of 2026-10-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 (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.
Eligibility Criteria
Inclusion Criteria: 1. Both Genders (Male /Female). 2. Age between 30 years to 60 years. 3. ASA Class I, II, III. Exclusion Criteria: 1. Patient refusal 2. Other distracting painful pathology 3. Any contraindication to Spinal Anesthesia or peripheral nerve blocks 4. Coagulopathic disorders 5. Patients with significant cognitive impairment 6. Patients with no pain while sitting by themselves without any support 7. H/O polytrauma involving other limbs 8. H/O allergy to the drugs used in study
Contact & Investigator
Adeel Riaz, MD
STUDY DIRECTOR
Sahiwal medical college sahiwal
Frequently Asked Questions
Who can join the NCT07221682 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 60 Years, studying Post Operative Analgesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07221682 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07221682 currently recruiting?
Yes, NCT07221682 is actively recruiting participants. Contact the research team at humairaali2323@gmail.com for enrollment information.
Where is the NCT07221682 trial being conducted?
This trial is being conducted at Sāhīwāl, Pakistan.
Who is sponsoring the NCT07221682 clinical trial?
NCT07221682 is sponsored by Sahiwal medical college sahiwal. The principal investigator is Adeel Riaz, MD at Sahiwal medical college sahiwal. The trial plans to enroll 60 participants.