Popliteal Sciatic Nerve Block and Adductor Canal Block

Sponsor

Istanbul Medeniyet University (Other)

Overall Status

Completed

CT.gov ID

NCT05960422

Collaborator

(none)

Enrollment

Location

Arms

5.3

Actual Duration (Months)

9.8

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Sep 1, 2021

Actual Primary Completion Date :

Jan 10, 2022

Actual Study Completion Date :

Feb 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.

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ezgi POLAT, Principal Investigator, Istanbul Medeniyet University

ClinicalTrials.gov Identifier:

NCT05960422

Other Study ID Numbers:

EzgiPOLAT

First Posted:

Jul 25, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ezgi POLAT, Principal Investigator, Istanbul Medeniyet University

Popliteal sciatic block, adductor canal block

Study Results

No Results Posted as of Aug 1, 2023