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Popliteal Sciatic Nerve BlockNCT07134608

Comparing Classical Approach and Crosswise Approach to Popliteal Sciatic Nerve Block

A study testing Popliteal Plexus Block with 20 ml in people with Popliteal Sciatic Nerve Block, run by National University of Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sensory and motor innervation below the knee is provided mainly by the popliteal-sciatic nerve except for a variable area of the medial leg supplied by the saphenous nerve. Regional anaesthesia and analgesia for below knee surgery are frequently provided by blocking the popliteal sciatic nerve in the popliteal fossa. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Popliteal Sciatic Nerve Block
What is being tested?
Popliteal Plexus Block with 20 ml
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteMalaysia
Study dates
1 Nov 2023to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • planned for either elective or non-elective unilateral below-knee surgery at HUKM
  • patients aged 18 years and older and classified as physical status I, II, or III as dictated by the American Society of Anaesthesiologists (ASA)

Who cannot join

  • included pregnant patients, those with a body mass index (BMI) ≥40 kg/m², contraindicated to peripheral nerve block (such as existing nerve injury to the limb intended for surgery), patient refusal, severe coagulopathy, local anaesthetic (LA) allergy, active infection at the intended block site, patients unable to provide a pain score using a verbal numerical rating scale (VNRS)

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Hospital Canselor Tuanku Muhriz

    Kuala Lumpur, Kuala Lumpur, 56000

Other trials in Malaysia

About this study

Official title: Classical Popliteal Sciatic Block Versus Crosswise Approach for Popliteal Sciatic (CAPS) Block in Below Knee Surgery:A Randomised Control Trial

Sensory and motor innervation below the knee is provided mainly by the popliteal-sciatic nerve except for a variable area of the medial leg supplied by the saphenous nerve. Regional anaesthesia and analgesia for below knee surgery are frequently provided by blocking the popliteal sciatic nerve in the popliteal fossa. Popliteal sciatic block was first introduced around the 1970s and has emerged as a popular technique for below knee surgery despite other types of lower limb peripheral nerve block. This is contributed because popliteal fossa offers a superficial and accessible location for nerve blockade. This anatomical feature simplifies the procedure and may reduce the risk of complications such as vascular puncture or nerve injury.

Analgesia provided by the popliteal sciatic block lasts significantly longer than with ankle blocks. One of the reasons is administration of local anaesthetic agent at the popliteal fossa allows it to bathe the sciatic nerve before it bifurcates into the tibial and common peroneal nerves, leading to a more extensive and prolonged nerve blockade. Besides the sciatic nerve at the popliteal level is encased in a common epineural sheath, which can facilitate the spread of the anaesthetic and prolong its effect. The popliteal sciatic block can be performed as a single-shot technique or as a continuous infusion via a catheter The success rate of popliteal sciatic block is dependent on several variables, including the operator's skill, patient considerations, and surgical variables.

This study comparing between 2 approaches of popliteal sciatic nerve ie: classical approach and relatively new approach that is crosswise approach of popliteal sciatic nerve (CAPS) block.

Being tested
Popliteal Plexus Block with 20 ml

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Popliteal Plexus Block with 20 mlProcedure or surgery

    Different position while blocking the popliteal sciatic nerve block

Study groups in NCT07134608
Study groupRoleWhat they receive
Classical Popliteal Sciatic Nerve BlockActive comparatorPatients turned to the right or left lateral decubitus position, depending on which lower limb was planned for operation (i.e., right lateral decubitus if the operation was on the left lower limb and vice-versa). A pillow was placed between the lower limbs to facilitate block access and patient comfort. The classical popliteal sciatic block was done using a ultrasound machine with a high-frequency linear or low-frequency curvilinear probe placed 5-6 cm cranial to the popliteal fossa crease while identifying the bifurcation of the sciatic nerve. Skin infiltration with 5 ml of lignocaine 2% was performed using a 23G,followed by in-plane introduction of an 80 mm 22G block needle, aiming to penetrate the sciatic nerve sheath at the level of bifurcation, with placement confirmed using a nerve stimulator. After confirming negative aspiration for blood, 20 ml of Ropivacaine 0.5% was injected, and the spread of LA within the sheath was confirmed by ultrasound.
Receives: Procedure: Popliteal Plexus Block with 20 ml
Crosswise Approach to Popliteal Sciatic Nerve (CAPS block)Active comparatorPatients in remained in the supine position. The CAPS block was performed using a similar Sonosite SII® ultrasound machine with a high-frequency linear or low-frequency curvilinear probe placed lateral to the thigh, 5-6 cm cranial to the popliteal fossa crease, while identifying the bifurcation of the sciatic nerve into the tibial and common peroneal nerves. Thereafter, the block proceeded similarly to patients in Group A, with 5 ml of lignocaine 2% for skin infiltration, in-plane introduction of the block needle aiming to penetrate the sciatic nerve sheath at the level of bifurcation and placement confirmed with a nerve stimulator, followed by injection of 20 ml of Ropivacaine 0.5% after confirming negative aspiration for blood. The spread of LA within the sheath was confirmed by ultrasound.
Receives: Procedure: Popliteal Plexus Block with 20 ml

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score during positioning and block performance

    Using verbal numerical rating scale (VNRS),ranging from 0 to 10, where 0 = no pain and 10 = the worst pain imaginable.

    Measured: Time from positioning and block performance until completion of block (preoperative).

Secondary outcomes (5)

  1. Fentanyl consumption

    Aliquots of intravenous (IV) fentanyl (25-50 micrograms) were given if the patient experienced pain with a VNRS ≥4 during positioning or block performance.

    Measured: On operative day until post operative day 1

  2. Onset of block

    Adequacy of the block was assessed at 5-minute intervals based on the loss of pain sensation to pin prick with a 23G (B. Braun®) needle in the distribution of the popliteal sciatic nerve (measure in minutes).

    Measured: Immediately after block completion until 30 minutes after.

  3. Failure rate

    Persistent pain sensation after 30 minutes over popliteal sciatic nerve distribution

    Measured: 30 minutes after block completion

  4. Patient's satisfaction

    Patient satisfaction with the block was assessed using a five-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).

    Measured: One day after procedure.

  5. Complications

    Such as hematoma, L.A toxicity, or persistent numbness/weakness lasting more than 24 hours.

    Measured: On operative day until post operative day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start1 Nov 2023
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

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
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07134608
Sponsor's protocol ID
JEPUKM-JEP-2023-973
Status last verified
May 2025
First submitted
21 Mar 2025
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Popliteal Plexus Block with 20 ml in people with Popliteal Sciatic Nerve Block, run by National University of Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score during positioning and block performance (time frame: Time from positioning and block performance until completion of block (preoperative).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07134608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

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