Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia i… (NCT07221682) | Clinical Trial Compass
RecruitingPhase 2/3
Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery
Pakistan60 participantsStarted 2024-05-06
Plain-language 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.
Who can participate
Age range
30 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Both Genders (Male /Female).
. Age between 30 years to 60 years.
. ASA Class I, II, III.
Exclusion criteria
. Patient refusal
. Other distracting painful pathology
. Any contraindication to Spinal Anesthesia or peripheral nerve blocks
. Coagulopathic disorders
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two different ways of doing a fascia iliaca nerve block — one above and one below the inguinal ligament — so would you be able to explain how each approach works and which one you currently use in standard care for my type of lower limb surgery?
2The main thing this trial is measuring is how easy it is to position me for a spinal anaesthetic, which suggests pain or muscle stiffness might be a real problem during that step — is that something you've seen cause difficulties for patients like me, and could either block approach genuinely make that safer or more comfortable?
3Since the trial is tracking drug-induced low blood pressure and slow heart rate as outcomes, it sounds like those are known risks with these blocks — how likely are those side effects in my situation, and how would the team monitor and manage them if they happened during my surgery?
4This is a Phase 2/3 trial, which means it's still building evidence on both safety and effectiveness — given that, do you think my specific procedure and health history make me a reasonable candidate to consider, or would sticking with whatever block technique your team already uses be a more straightforward choice for me?
5Are there any differences in how long the pain relief would last or what recovery would look like after surgery depending on which block is used in this trial, and how does that compare to what I'd experience outside of the trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ease of Spinal Positioning
Timeframe: From performance of block to spinal anesthesia procedure begins