NCT05960422

Brief Summary

The goal of this observational study is to determine the effect of adding adductor canal block to popliteal sciatic nerve block on patient-surgeon satisfaction, intraoperative sedation need, tourniquet pain, return time of motor block, and postoperative pain in patients undergoing hallux valgus correction surgery. The main question it aims to answer are:

  • Does peroperative pain decrease?
  • Do patient-surgeon satisfaction increase? The patients were divided into two groups, the Popliteal Sciatic Block (PSB) group, and the Popliteal Sciatic Block + Adductor Canal Block (PSB + ACB) group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

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

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 17, 2023

Last Update Submit

July 27, 2023

Conditions

Keywords

Popliteal sciatic block, adductor canal block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    The Numeric Pain Rating Scale (NPRS). Between 1-10. The low values mean low pain and a better outcome.

    Postoperative 24 hours

Study Arms (2)

Popliteal Sciatic Nerve Block

ACTIVE COMPARATOR

Patients are in the group undergoing popliteal sciatic block

Procedure: Popliteal Sciatic Nerve Block

Adductor Canal Block

ACTIVE COMPARATOR

Patients are in the group undergoing popliteal sciatic block + adductor canal block

Procedure: Adductor canal block

Interventions

Patients undergoing popliteal sciatic block, the side where the procedure would be performed in the prone position was sterilized after appropriate antisepsis. After visualizing the popliteal artery in the popliteal fossa with the probe it was advanced proximally in a horizontal and minimally lateral position to determine the point of separation of the tibial and peroneal nerves from the sciatic nerve. Subcutaneous local anesthesia was applied at this point after the skin, and the stimulator needle was advanced towards the sciatic nerve in an in-plane approach, passing through the skin and subcutaneous tissue, and then the nerve stimulator was opened up to 1 mA. After observing motor movement in the foot, the stimulator was reduced to 0.3-0.5 mA, and after observing motor movements for duration of 0.1 ms, 10 ml of 0.5% bupivacaine + 10 ml of 2% prilocaine were administered to the target tissue

Popliteal Sciatic Nerve Block

Patients in the group undergoing popliteal sciatic block + adductor canal block, with the extremity to be blocked slightly externally rotated, the anterior part of the thigh was prepared with the necessary antiseptic procedures while the patient was in the supine position. Using an ultrasound probe, the femoral artery was visualized by advancing the ultrasound probe distally, and the saphenous nerve was identified just lateral to the femoral artery, beneath the sartorius muscle. At the junction of the sartorius muscle and vastus medialis, 10 ml of 0.5% bupivacaine + 10 ml of 2% prilocaine were applied to the periphery of the saphenous nerve. Subsequently, the patient was turned prone, and a popliteal sciatic block was performed.

Adductor Canal Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18 and 80
  • American Society of Anesthesiologists ASA I-III

You may not qualify if:

  • Patients with coagulopathy
  • Patient with wounds or infections in the region
  • Patient with allergies to local anesthetic drugs
  • Patient with significantly impaired peripheral neuropathy and neurogenic disorders affecting the lower extremity
  • Patient with peripheral arterial disease
  • Patient with mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Faculty of Medicine Department of Anesthesiology and Reanimation

Istanbul, Kadikoy, 34720, Turkey (Türkiye)

Location

Study Officials

  • Ezgi Polat

    İstanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 25, 2023

Study Start

September 1, 2021

Primary Completion

January 10, 2022

Study Completion

February 10, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations