The Efficacy of Gastrocnemius Plane Block for Foot and Ankle Surgery: A Randomised Controlled Trial
| Registry | NCT07877974 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Cairo University (Other) |
| Conditions | Gastrocnemius, Ankle Surgery, Foot Surgery, Postoperative Analgesia |
| Interventions | GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%), SAB (Drug) |
| Dates | start 2026-11-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-10-16, last updated 2026-10-16 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Gastrocnemius All trials for Ankle Surgery All trials of GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%) All trials of SAB
The study aim is to evaluate the efficacy of the gastrocnemius plane block (GPB) in providing postoperative analgesia for patients undergoing foot and ankle surgery.
Objectives:
* To evaluate the duration of postoperative analgesia provided by the gastrocnemius plane block
* To assess postoperative opioid or rescue analgesic consumption within the first 24 hours after surgery
* To measure postoperative pain intensity at predefined time intervals using a validated pain scale (e.g., VAS).
* To assess the incidence of block-related complications, including motor weakness, vascular puncture, nerve injury, or local anesthetic systemic toxicity We hypothesize that GPB will result in lower postoperative pain scores and reduce opioid/rescue analgesic consumption compared with standard analgesic management after foot and ankle surgery.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| GPB Group | Active comparator | Drug: GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%); Drug: SAB | GPB Group will receive Gastrocnemius plane block with 30 mL bupivacaine (0.25%) |
| Control Group | Placebo comparator | Drug: GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%); Drug: SAB | Control Group will receive ultrasound-guided Gastrocnemius plane block with 30 mL normal saline . |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * Elective foot and ankle surgeries, including procedures for fractures of the fibula, tibia-fibula, metatarsal, or calcaneus, as well as corrective surgery for hallux valgus; * Aged 18- 65 years * BMI 18-28 kg/m2 * ASA Ⅰ-Ⅲ. Exclusion Criteria: * Puncture site infection * Abnormal coagulation function: international normalized ratio (INR) > 1.5; platelet count < 50×109/L * Local anaesthesia allergy * Unstable coronary syndrome (e.g., recent myocardial infarction within 3 months); * Severe cardiopulmonary disease: heart failure (NYHA, functional class III or IV) * Severe pulmonary disease (e.g., chronic obstructive pulmonary disease with FEV1 < 50% of predicted, or requiring home oxygen therapy) * Liver insufficiency: liver disease (Child- Pugh class B or C) or elevated liver enzymes (ALT or AST) > 3 times the upper limit of normal; * Renal insufficiency renal impairment (estimated glomerular filtration rate, eGFR<30 mL/min/1.73m2) or requiring renal replacement therapy * Long-term preoperative use of sedative and analgesic drugs; * Communication disorders * History of chronic pain. * Operative time > 3 h.
| Facility | City | Country | Status |
|---|---|---|---|
| Cairo university , faculty of medicine | Cairo, Governorate | Egypt | Recruiting |