Ireland
--:--IST
Recruiting Not applicable

Efficacy of Gastrocnemius Plane Block for Foot and Ankle Surgery

NCT07877974 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-11
Last updated
2026-10-16

Condition(s) studied

GastrocnemiusAnkle SurgeryFoot SurgeryPostoperative Analgesia

Investigational drug(s) / intervention(s)

GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%)SAB

GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%): o In lateral position, a high frequency US (Siemens ACUSON X300 Ultrasound System) linear probe (8-12 mhz) will be placed in the popliteal fossa facing the operator. Scanning continue towards the foot, and the gastrocnemius will appear. As the scanning progresses towards the caput fibulae, the soleus gradually becomes visible. Once Gastrosoleus Interfascial Plane is identified, a needle advanced by consultant anesthesiologists who had experience in regional anesthesia in a lateral-to-medial direction into the lower surface of the gastrocnemius (between the gastrocnemius and the soleus). Subsequently, 20 mL bupivacaine (0.25%) will be injected to separate the fascias of the two muscles, allowing the local anaesthetic to diffuse around the tibial nerve through the fascial gap. The needle is then withdrawn to the upper surface of the gastrocnemius, and 10 mL bupivacaine (0.25%) will be injected into the upper surface (between gastrocnemius and deep subcutaneous fascia) to block

SAB: * Patients will receive SAB using 25g spinal needle in the lateral position with rapid crystalloid co-loading. Fifteen milligrams of hyperbaric bupivacaine will be administered at L3-L4 or at L4-L5 interspace in addition to 25 mcg fentanyl. The dose will be reduced to 10 mg in patients aged above 60 years. * SAB will be considered successful when a bilateral block is confirmed at T12. The block success will be assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations. If spinal anaesthesia fails, the patient will receive general anaesthesia and will be excluded from the study.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Time to first postoperative analgesic request — 24 hours
    Time to first postoperative analgesic request

Trial sites (1)

FacilityCityRegionStatus
Cairo university , faculty of medicine Cairo Governorate Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07877974 on ClinicalTrials.gov ↗ ← All trials in Egypt