NCT04010916

Brief Summary

The ultrasound-guided selective blockade of the saphenous nerve in the adductor canal provides effective analgesia and reduces postoperative pain in patients undergoing arthroscopic medial meniscectomy. Selective blockade of the saphenous nerve in the adductor canal provides effective analgesia without quadriceps muscle weakness. It has been shown that usage of tourniquet during performing the adductor canal block (ACB) block increases the spread of local anesthetics in a distal and proximal way. Therefore, the proximal spread of local anesthetics may cause possible quadriceps weakness. The distal spread of local anesthetics may increase analgesic effect via sciatic nerve. The timing of the tourniquet inflation for ACB is a topic of discussion.The aim of this study is to compare the different times of US-guided ACB performing for postoperative analgesia management after arthroscopic knee surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

July 1, 2019

Last Update Submit

May 20, 2021

Conditions

Keywords

Postoperative analgesiaAdductor canal blockKnee arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Fentanyl using

    Postoperative 24 hours

Secondary Outcomes (1)

  • Postoperative pain scores

    Postoperative 24 hours period

Study Arms (3)

Group Pre = preoperatively before inflation of the tourniquet

ACTIVE COMPARATOR

ACB will be performed under general anesthesia in the supine position. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit

Other: Group Preoperatively Adductor Canal Block

Group Pre-T = preoperatively after inflation of the tourniquet

ACTIVE COMPARATOR

ACB will be performed under general anesthesia in the supine position. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit

Other: Group Preoperatively Tourniquet Adductor Canal Block

Group Post = Postoperatively group

ACTIVE COMPARATOR

ACB will be performed under general anesthesia in the supine position. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit

Other: Group Postoperatively Adductor Canal Block

Interventions

The ACB will be performed preoperatively before inflation of the tourniquet. After identifing the adductor canal, by using the in-plane technique, the probe will be placed at the mid-thigh, half the distance between the inguinal crease and the patella, for block location. The superficial femoral artery will be visualized dorsal to the sartorius muscle. Then, the probe will be remowed to distally. At this level, the hyperechoic view of the saphenous nerve will be visualized lateral and anterior to the artery in the subsartorial region. 5 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 30 mL will be injected here.

Group Pre = preoperatively before inflation of the tourniquet

The ACB will be performed preoperatively after inflation of the tourniquet. After identifing the adductor canal, by using the in-plane technique, the probe will be placed at the mid-thigh, half the distance between the inguinal crease and the patella, for block location. The superficial femoral artery will be visualized dorsal to the sartorius muscle. Then, the probe will be remowed to distally. At this level, the hyperechoic view of the saphenous nerve will be visualized lateral and anterior to the artery in the subsartorial region. 5 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 30 mL will be injected here.

Group Pre-T = preoperatively after inflation of the tourniquet

The ACB will be performed postoperatively. After identifing the adductor canal, by using the in-plane technique, the probe will be placed at the mid-thigh, half the distance between the inguinal crease and the patella, for block location. The superficial femoral artery will be visualized dorsal to the sartorius muscle. Then, the probe will be remowed to distally. At this level, the hyperechoic view of the saphenous nerve will be visualized lateral and anterior to the artery in the subsartorial region. 5 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 30 mL will be injected here.

Group Post = Postoperatively group

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for arthroscopic knee surgery under general anesthesia

You may not qualify if:

  • Bleeding diathesis
  • Receiving anticoagulant treatment
  • Known local anesthetics and opioid allergy
  • Infection of the skin at the site of the needle puncture
  • Pregnancy or lactation
  • Patients who do not accept the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

  • Kejriwal R, Cooper J, Legg A, Stanley J, Rosenfeldt MP, Walsh SJ. Efficacy of the Adductor Canal Approach to Saphenous Nerve Block for Anterior Cruciate Ligament Reconstruction With Hamstring Autograft: A Randomized Controlled Trial. Orthop J Sports Med. 2018 Oct 10;6(10):2325967118800948. doi: 10.1177/2325967118800948. eCollection 2018 Oct.

    PMID: 30345322BACKGROUND
  • Hanson NA, Derby RE, Auyong DB, Salinas FV, Delucca C, Nagy R, Yu Z, Slee AE. Ultrasound-guided adductor canal block for arthroscopic medial meniscectomy: a randomized, double-blind trial. Can J Anaesth. 2013 Sep;60(9):874-80. doi: 10.1007/s12630-013-9992-9. Epub 2013 Jul 3.

    PMID: 23820968BACKGROUND
  • Jaeger P, Jenstrup MT, Lund J, Siersma V, Brondum V, Hilsted KL, Dahl JB. Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95. Br J Anaesth. 2015 Dec;115(6):920-6. doi: 10.1093/bja/aev362.

    PMID: 26582853BACKGROUND

Study Officials

  • Bahadir Ciftci, Asist.Prof

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor and participant were blinded to the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Ninety patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for arthroscopic knee surgery will be included in the study. Patients will be randomly divided into three groups (Group Pre = preoperatively before inflation of the tourniquet group, Group Pre-T = preoperatively after inflation of the tourniquet group, Group Post = Postoperatively group) including 30 patients each, before entering the operating room.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 8, 2019

Study Start

July 1, 2019

Primary Completion

May 20, 2021

Study Completion

May 20, 2021

Last Updated

May 21, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared

Locations