The Efficacy of Adding Dexmedetomidine Perineurally to Bupivacaine in Ultrasound Guided Fascia Iliaca Block Versus Intravenously Infused Dexmedetomidine on Hemodynamic Stability Intraoperatively and Postoperative Analgesia Following Hip Arthroscopy

NCT04917029 | Completed

• 1 other identifier: FMASU R 116/2021
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to assess effectiveness of dexmedetomidine as adjuvant to general anesthesia on the hemodynamic stability and narcotic consumption intraoperatively and its effect as adjuvant to fascia iliaca compartment block (FICB) with bupivacaine on the postoperative analgesia following hip arthroscopy (decrease the need to narcotics postoperatively avoiding their complications and increasing the success rate of surgery, by enhancing patients to move easier).

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Effect of dexmedetomidine infusion

  incidence of need rescue agents (fentanyl) intraoperatively and the rate change in heart rate ang blood pressure

  introperative

Secondary Outcomes (1)

• Visual Analogue scale (VAS)

  24 hours postoperative

Study Arms (2)

Active:Group A

ACTIVE COMPARATOR

Group A: receive 40 ml bupivacaine 0.25% +5 ml placebo in FICB perineurally in generally anaesthetized patients with intravenous infusion of 0.5 µg/kg/h of Dexmedetomidine.

Drug: Bupivacaine hydrochloride perineurally; Drug: Dexmedetmidine infusion

(Group B

ACTIVE COMPARATOR

Group B: receive FICB with dexmedetomidine 80µg diluted in 5 ml normal saline and 40 ml bupivacaine 0.25% added perineurally in generally anaesthetized patients without dexmedetomidine infusion.

Drug: Bupivacaine hydrochloride perineurally; Drug: Dexmedetomidine perineurally

Interventions

Bupivacaine hydrochloride perineurally DRUG

Arm 1; Bupivacaine hydrochloride 40 ml 0.25% perineurally in FICB

Also known as: marcaine

(Group B; Active:Group A

Dexmedetmidine infusion DRUG

Arm 1: infusion of Dexmedetmidine 0.5 µg/kg/h

Also known as: precedex

Active:Group A

Dexmedetomidine perineurally DRUG

Arm 2:Dexmedetomidine perineurally in FICB 80µg

Also known as: precedex

(Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective hip arthroscopy.
• ASA I and II patients
• aged 18 to 65 years,
• kg,
• both sexes.

You may not qualify if:

• Refusal of the patient to receive FICB or to participate in the study,
• Impaired renal or hepatic functions,
• Asthmatic patients.
• Patients with multiple traumas.
• Obese patients with Body Mass Index \> 35.
• Allergy to study drugs.
• Patients with local infection.
• Previous surgery at the injection area.
• Bleeding disorders.
• Patients on anticoagulant therapy,
• Addicts.
• Patients with an opioid analgesic prescription within the last 2 h before the operation.
• Peripheral neuropathy,
• Mental and or psychiatric disorders.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Maha Sadek EL Derh

Cairo, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 8, 2021
• Study Start: May 18, 2021
• Primary Completion: August 18, 2021
• Study Completion: August 31, 2021
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)