ClinicalTrials.gg
RecruitingNCT07877974Updated Oct 16, 2026

Efficacy of Gastrocnemius Plane Block for Foot and Ankle Surgery

An interventional study of GPB Group : This group will receive ultrasound-guided Gastrocnemius plane block with 30 mL bupivacaine (0.25%) and SAB in Gastrocnemius, Ankle Surgery and Foot Surgery, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.
02

Conditions studied

  • Gastrocnemius
  • Ankle Surgery
  • Foot Surgery
  • Postoperative Analgesia

Keywords

  • Gastrocnemius
  • Foot and Ankle Surgery
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    GPB Group

    GPB Group will receive Gastrocnemius plane block with 30 mL bupivacaine (0.25%)

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

  • Placebo comparator
    Control Group

    Control Group will receive ultrasound-guided Gastrocnemius plane block with 30 mL normal saline .

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

Interventions

  • DrugGPB 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

  • DrugSAB

    * 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.

06

What researchers measure

Primary outcomes

  1. Time to first postoperative analgesic request

    Time to first postoperative analgesic request

    Time frame: 24 hours

Secondary outcomes

  1. 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

    Time frame: 24 hours

  2. 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)

    Time frame: 24 hours

  3. Time to first postoperative analgesic request

    Time to first postoperative analgesic request

    Time frame: 24 hours

  4. Total morphine requirements

    Total morphine requirements 24 hours postoperatively.

    Time frame: 24 hours

  5. Time to early mobilization

    Time to early mobilization: First bedtime helps to judge the effect of the nerve block

    Time frame: 24 hours

  6. Incidence of complications related to the blocks

    Incidence of complications related to the blocks as hematoma or Toxicity

    Time frame: 24 hours

  7. Incidence of postoperative nausea and vomiting

    Incidence of postoperative nausea and vomiting

    Time frame: 24 hours

  8. 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

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • Cairo university , faculty of medicine
    Cairo, Governorate 002, Egypt
    • Nagy Malak · Contact · nagymalak789@yahoo.com · 01552480258
    • Nagy Malak, MD · Contact · 01552480258
    • Batulo Mohamed Mohamud, MBBch · Sub investigator
    • Mahmoud Sewilam, MD · Principal investigator
    • Ahmed Ragab, MD · Principal investigator
    • Amany Hassan, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07877974
Lead sponsor
Cairo University
Responsible party
Nagy Malak , MD (Dr, Cairo University) — Principal investigator
First posted
Oct 16, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Oct 16, 2026

Study contacts

Nagy Malak, MD
Contact
nagymalak@kasralainy.edu.eg
01552480258
Nagy Malak, MD
Contact
nagymalak12345@gmail.com
01552480258
Nagy Malak, MD
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion