NCT07134608

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
Last Updated

August 21, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

March 21, 2025

Last Update Submit

August 19, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

  • Fentanyl consumption

    On operative day until post operative day 1

  • Onset of block

    Immediately after block completion until 30 minutes after.

  • Failure rate

    30 minutes after block completion

  • Patient's satisfaction

    One day after procedure.

  • Complications

    On operative day until post operative day 1

Study Arms (2)

Classical Popliteal Sciatic Nerve Block

ACTIVE COMPARATOR

Patients 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.

Procedure: Popliteal Plexus Block with 20 ml

Crosswise Approach to Popliteal Sciatic Nerve (CAPS block)

ACTIVE COMPARATOR

Patients 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.

Procedure: Popliteal Plexus Block with 20 ml

Interventions

Different position while blocking the popliteal sciatic nerve block

Classical Popliteal Sciatic Nerve BlockCrosswise Approach to Popliteal Sciatic Nerve (CAPS block)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Canselor Tuanku Muhriz

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2025

First Posted

August 21, 2025

Study Start

November 1, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

August 21, 2025

Record last verified: 2025-05

Locations