GastrocnemiusNCT07877974
Efficacy of Gastrocnemius Plane Block for Foot and Ankle Surgery
A study testing GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%) and SAB in people with Gastrocnemius and Ankle Surgery, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastrocnemius, Ankle Surgery, Foot Surgery
- What is being tested?
- GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%) and SAB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to Mar 2027
- Phase
- Interventional
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university , faculty of medicine
Cairo, Governorate, 002
Nagy Malak, 01552480258, nagymalak789@yahoo.com
Nagy Malak, MD, 01552480258
About this study
Official title: The Efficacy of Gastrocnemius Plane Block for Foot and Ankle Surgery: A Randomised Controlled Trial
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.
- Conditions
- Gastrocnemius, Ankle Surgery, Foot Surgery, Postoperative Analgesia
- Being tested
- GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%), SAB
- Keywords
- Gastrocnemius, Foot and Ankle Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%)Drug
- 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
SABDrug
- 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 group | Role | What they receive |
|---|---|---|
| GPB Group | Active comparator | GPB Group will receive Gastrocnemius plane block with 30 mL bupivacaine (0.25%) Receives: Drug: GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%); Drug: SAB |
| Control Group | Placebo comparator | Control Group will receive ultrasound-guided Gastrocnemius plane block with 30 mL normal saline . Receives: Drug: GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%); Drug: SAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first postoperative analgesic request
Time to first postoperative analgesic request
Measured: 24 hours
Secondary outcomes (8)
Visual analogue pain score (VAS)
Visual analogue pain score (VAS) at rest (static), and on movement (dynamic) at 2, 4, 6, 12, 18, and 24 hours postoperatively
Measured: 24 hours
Postoperative assessment of sensory and motor function
Assessment of sensory block: Sensory block will be assessed using a pinprick test with a blunt 22-gauge needle along dermatomes relevant to the surgery. The degree of sensory loss will be graded as follows:
- Grade 0: Normal sensation to pinprick
- Grade 1: Decreased but present sensation to pinprick (hypoalgesia)
- Grade 2: Complete loss of sensation to pinprick (analgesia)
Measured: 24 hours
Time to first postoperative analgesic request
Time to first postoperative analgesic request
Measured: 24 hours
Total morphine requirements
Total morphine requirements 24 hours postoperatively.
Measured: 24 hours
Time to early mobilization
Time to early mobilization: First bedtime helps to judge the effect of the nerve block
Measured: 24 hours
Incidence of complications related to the blocks
Incidence of complications related to the blocks as hematoma or Toxicity
Measured: 24 hours
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting
Measured: 24 hours
Postoperative assessment of motor function
Assessment of motor block: using the Modified Bromage score, which will be evaluated to assess the motor block as follows:
- Bromage 0: full flexion of the knee and feet.
- Bromage 1: just able to move the knee
- Bromage 2: able to move the feet.
- Bromage 3: unable to move the knees and feet
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrocnemiusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagy Malak , MD, Cairo University
- Investigators
- Nagy Malak, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877974
- Sponsor's protocol ID
- MS-222-2026
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided