NCT06758245

Brief Summary

Comparison of Anesthetic and Postoperative Analgesic Efficacy of Femoral and Popliteal Sciatic Block vs Femoral and Anterior Sciatic Block in Ankle Surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

December 26, 2024

Last Update Submit

August 21, 2025

Conditions

Keywords

nerve blocksankle surgerypostoperative painsciatic blockfemoral block

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale values

    Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.

    at 1st, 4th,8th 12th ,24th and 48th hours after the surgery

Secondary Outcomes (1)

  • Total amount of opioid requirements

    within 48 hours after the surgery

Study Arms (2)

Femoral-Anterior sciatic block group

ACTIVE COMPARATOR

First, in the supine position, the USG probe is placed below the inguinal crease. The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle. Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied. Patellar movement is observed due to quadriceps muscle contraction upon needle placement. After a negative aspiration test, 20 ml of local anesthetic is injected.For the anterior sciatic block, while the patient was in the supine position, a convex ultrasound (USG) probe was placed transversely approximately 10 cm distal to the inguinal ligament. After visualizing the sciatic nerve as a hyperechoic flat structure, the nerve stimulator was set to 1-1.5 mA, 0.1 ms, and 1 Hz. Using an in-plane technique, the block needle was advanced. Upon reaching the sciatic nerve, when contractions in the calf, foot, or big toe continued at a current of 0.3-0.5 mA, 20 ml of 0.5% bupivacaine was administered following a negative aspiration test.

Procedure: femoral and anterior sciatic nerve block

Femoral-popliteal sciatic block group

ACTIVE COMPARATOR

First, in the supine position, the USG probe is placed below the inguinal crease. The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle. Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied. Patellar movement is observed due to quadriceps muscle contraction upon needle placement. After a negative aspiration test, 20 ml of local anesthetic is injected.The ultrasound probe is placed transversely at the popliteal crease. The first structure seen is the popliteal artery. Just above and lateral to the artery, the tibial nerve appears as a hyperechoic, oval, and round structure. After identifying the tibial and peroneal nerves, the probe is moved proximally, and it is observed that the nerves join about 5-10 cm above the popliteal crease. The needle is advanced using an in-plane technique. After obtaining the first sciatic nerve stimulation, 20 cc of 0.5% bupivacaine is injected following a negative aspiration test.

Procedure: femoral and popliteal sciatic nerve block

Interventions

First, in the supine position, the USG probe is placed below the inguinal crease. The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle. Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied. Patellar movement is observed due to quadriceps muscle contraction upon needle placement. After a negative aspiration test, 20 ml of local anesthetic is injected.For the anterior sciatic block, while the patient was in the supine position, a convex ultrasound (USG) probe was placed transversely approximately 10 cm distal to the inguinal ligament. After visualizing the sciatic nerve as a hyperechoic flat structure, the nerve stimulator was set to 1-1.5 mA, 0.1 ms, and 1 Hz. Using an in-plane technique, the block needle was advanced. Upon reaching the sciatic nerve, when contractions in the calf, foot, or big toe continued at a current of 0.3-0.5 mA, 20 ml of 0.5% bupivacaine was administered following a negative aspiration test.

Femoral-Anterior sciatic block group

The ultrasound probe is placed transversely at the popliteal crease. The first structure seen is the popliteal artery. Just above and lateral to the artery, the tibial nerve appears as a hyperechoic, oval, and round structure. After identifying the tibial and peroneal nerves, the probe is moved proximally, and it is observed that the nerves join about 5-10 cm above the popliteal crease. The needle is advanced using an in-plane technique. After obtaining the first sciatic nerve stimulation, 20 cc of 0.5% bupivacaine is injected following a negative aspiration test.

Femoral-popliteal sciatic block group

Eligibility Criteria

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

You may qualify if:

  • years of age
  • American Society of Anesthesiologists physical statusⅠ-II

You may not qualify if:

  • Pregnant
  • Neuromuscular disease
  • Peripheral neuropathy
  • Coagulation disorders
  • Allergy to local anesthetics
  • Infection at the site where the nerve block will be applied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaziosmanpasa Training and Research Hospital, Istanbul, 34000

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Olofsson M, Nguyen A, Rossel JB, Albrecht E. Duration of analgesia after forefoot surgery compared between an ankle and a sciatic nerve block at the popliteal crease: A randomised controlled single-blinded trial. Eur J Anaesthesiol. 2024 Jan 1;41(1):55-60. doi: 10.1097/EJA.0000000000001929. Epub 2023 Nov 16.

    PMID: 37972929BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Döndü GENÇ MORALAR, MD

    GAZİOSMANPAŞA RESEARCH AND TRAİNİNG HOSPİTAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

November 24, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations