Popliteal Sciatic Nerve Block and Adductor Canal Block

• ClinicalTrials.gov Identifier: NCT05960422
• Recruitment Status: Completed
• First Posted: July 25, 2023
• Last Update Posted: August 1, 2023
• Sponsor: Istanbul Medeniyet University
• Information provided by (Responsible Party): Ezgi POLAT, Istanbul Medeniyet University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Popliteal Sciatic Nerve Block; Adductor Canal Block	Procedure: Popliteal Sciatic Nerve Block; Procedure: Adductor canal block	Not Applicable

Detailed Description:

Patients were randomly assigned into 2 groups as popliteal sciatic nerve block (Group PSB), popliteal sciatic nerve + adductor canal block (Group PSB + ACB). In this study, 52 patients scheduled for hallux valgus correction operations, in the American Society of Anesthesiologists I-III groups, between the ages of 18-80, were enrolled. Study was planned as a prospective, randomized and controlled trial. All patients were perfomed PSB with 10 ml 0.5% bupivacaine and 10 ml 2% prilocaine in the prone position, using ultrasonography and nerve stimulator. 10 ml of 0.5% bupivacaine and 10 ml of 2% prilocaine were administered to the patients in the ACB + PSB group in the supine position, in addition to PSB. Patients with coagulopathy, infection at the region site of regional blockade, allergy of local anesthetic drugs, peripheral neuropathy and neurogenic disorders affecting the lower extremities, peripheral artery disease, mental retardation and those who did not give consent to study were excluded. All patients were sedated with 1-2 mg midazolam and 50 µg fentanyl. After the blocks were performed , sensory -motor block onset time, surgery-tourniquet time, tourniquet pain, motor block time, pain onset time, first analgesic administration time (NPRS≥4) and analgesic administered were recorded. Anesthesiologists evaluating these data were blinded to group distribution .

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Adding Adductor Canal Block to Popliteal Sciatic Nerve Block in Hallux Valgus Correction Operations
• Actual Study Start Date: September 1, 2021
• Actual Primary Completion Date: January 10, 2022
• Actual Study Completion Date: February 10, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Popliteal Sciatic Nerve Block; Patients are in the group undergoing popliteal sciatic block	Procedure: Popliteal Sciatic Nerve Block; 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
Active Comparator: Adductor Canal Block; Patients are in the group undergoing popliteal sciatic block + adductor canal block	Procedure: Adductor canal 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.

Outcome Measures

Primary Outcome Measures :

1. Postoperative Pain [ Time Frame: Postoperative 24 hours ]
   The Numeric Pain Rating Scale (NPRS). Between 1-10. The low values mean low pain and a better outcome.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Turkey

Istanbul Medeniyet University Faculty of Medicine Department of Anesthesiology and Reanimation

Istanbul, Kadikoy, Turkey, 34720

Sponsors and Collaborators

Istanbul Medeniyet University

Investigators

• Principal Investigator: Ezgi Polat; İstanbul Medeniyet University

More Information

• Responsible Party: Ezgi POLAT, Principal Investigator, Istanbul Medeniyet University
• ClinicalTrials.gov Identifier: NCT05960422
• Other Study ID Numbers: EzgiPOLAT
• First Posted: July 25, 2023
• Last Update Posted: August 1, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ezgi POLAT, Istanbul Medeniyet University:

Popliteal sciatic block, adductor canal block