Perineural Dexmedetomidine in Adductor Canal Block

NCT03030950 | Completed Phase 4

• 1 other identifier: N-31-2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to explore the effects of peri-neural dexmedetomidine on the duration and motor sparing potentials of adductor canal block in adult patients undergoing arthroscopic medical meniscectomy in the setting of multimodal analgesia. The investigators ultimate goal is to increase the postoperative analgesic time and to preserve quadriceps muscle strength to promote safe and early ambulation.

Conditions

Arthroscopic Medial Meniscectomy

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  the time passed till the patient first analgesic request

  24 hours

Secondary Outcomes (8)

• richmond agitation sedation scale

  24 hours

• duration of sensory block

  24 hours

• onset of sensory block

  minutes

• blood pressure

  24 hours

• heart rate

  24 hours

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Adductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle.

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

Adductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle.

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

to investigate the effect of dexmedetomidine on motor and sensory properties of adductor canal block

Also known as: Precedex

Dexmedetomidine group

Normal saline DRUG

to give normal saline to the other group as a placebo

Also known as: Saline

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients of aged (18-45), ASA physical status I or II undergoing arthroscopic medial meniscectomy.

You may not qualify if:

• Body mass index greater than 35 kg/m2.
• Pregnancy.
• Unstable coronary artery disease, congestive heart failure, or arrhythmias.
• Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure less than 100 mmHg.
• Pre-existing neurological deficits or neuropathy.
• Significant psychiatric or cognitive conditions interfering with consent or assessment.
• Significant renal or hepatic impairment;
• Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea.
• Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
• Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mohamed Abdulatif, Professor

  Professor and member of research committee of anesthesia department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and critical care medicine

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 25, 2017
• Study Start: January 25, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 5, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)