Combined Intravenous Dexamethasone and Dexmedetomidine as Adjuncts to Popliteal and Saphenous Nerve Blocks in Patients Undergoing Orthopaedic Surgery of the Foot and Ankle

NCT04818749 | Completed Phase 4

• 1 other identifier: ADJUNCT2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators will investigate the beneficial and harmful effects of combining dexamethasone (12 mg) and dexmedetomidine (1mcg/kg) as adjuncts to popliteal and saphenous nerve blocks in patients undergoing surgery of their foot or ankle.

Conditions

Anesthesia, Local

Keywords

Regional anesthesia; Dexamethasone; Dexmedetomidine; Adductor canal block; Saphenous nerve block; Popliteal nerve block; Peripheral nerve block

Outcome Measures

Primary Outcomes (1)

• Time to first pain (measured in minutes)

  Time to first pain will be recorded by the patient and measured in minutes as the time to first perceived pain in the surgical area. The patient will be asked to record the time and date of their first perceived pain in their trial log. This date and time will be compared to the date and time of block performance as recorded in the electronic Case Report Form. In the event of the patient not experiencing any pain, the time to first pain will be set to 72 hours.

  72 hours

Secondary Outcomes (6)

• Duration of the motor block (measured in minutes)

  72 hours

• Quality of sleep (measured on the Numerical Rating Scale) postoperative night 1

  24 hours

• Quality of sleep (measured on the Numerical Rating Scale) postoperative night 2

  48 hours

• Quality of sleep (measured on the Numerical Rating Scale) postoperative night 3

  72 hours

• Proportion of participants with one or more serious adverse events

  30 days

Other Outcomes (13)

• Cumulative oxycodone consumption (measured in milligrams) at 24 hours

  24 hours

• Cumulative oxycodone consumption (measured in milligrams) at 48 hours

  48 hours

• Cumulative oxycodone consumption (measured in milligrams) at 72 hours

  72 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants allocated to this arm will have placebo administered intravenously before block performance and placebo administered intravenously after induction of general anaesthesia.

Drug: Saline

Dexamethasone 12 mg

ACTIVE COMPARATOR

Participants allocated to this arm will have dexamethasone 12 administered intravenously before block performance and placebo administered intravenously after induction of general anaesthesia.

Drug: Dexamethasone 12 mg

Dexamethasone 12 mg + dexmedetomidine 1 mcg/kg

EXPERIMENTAL

Participants allocated to this arm will have dexamethasone 12 administered intravenously before block performance and dexmedetomidine 1 mcg/kg administered intravenously after induction of general anaesthesia.

Drug: Dexamethasone 12 mg + dexmedetomidine 1 mcg/kg

Interventions

Saline DRUG

Saline (placebo) will be administered intravenously before block performance and after the induction of general anaesthesia.

Also known as: Placebo

Placebo

Dexamethasone 12 mg DRUG

Dexamethasone 12 mg will be administered intravenously before block performance and saline (placebo) will be administered intravenously after the induction of general anaesthesia.

Dexamethasone 12 mg

Dexamethasone 12 mg + dexmedetomidine 1 mcg/kg DRUG

Dexamethasone 12 mg will be administered intravenously before block performance and dexmedetomidine 1 mcg/kg will be administered intravenously after the induction of general anaesthesia.

Dexamethasone 12 mg + dexmedetomidine 1 mcg/kg

Eligibility Criteria

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

You may qualify if:

• Scheduled for unilateral osseous surgery of the ankle or foot
• General anaesthesia with both a popliteal and a saphenous nerve block for postoperative analgesia
• Age of 18 or above
• American Society of Anaesthesiologists Physical Status Score of 1 to 3
• Body Mass Index of 18 to 40, but a minimum weight of 50 kg.
• For fertile women, negative urine humane choriongonadotropine test and use of safe anti-conception
• Ability to understand the trial protocol, risks, benefits, and provide signed informed consent

You may not qualify if:

• Inability to read and understand Danish
• Uncooperativeness (as judged by investigators)
• Participation in another trial involving medication
• Allergy to study medication
• Daily use of opioids above 30 mg/day morphine (or equivalents)
• Daily use of corticosteroids of more than 5 mg prednisolone equivalents within the past one month
• Neurological or musculoskeletal disease making block performance impossible (as judged by investigators)
• Dysregulated diabetes (as judged by investigators)
• Dysregulated anticoagulants (as judged by investigators)
• History of drug or alcohol abuse
• Glaucoma
• Contraindications for paracetamol or opioids
• Contraindications to general anaesthesia
• Other concomitant conditions needing surgery
• Other concomitant traumatic injuries

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (2)

Department of Anaesthesiology

Køge, Zealand Region of Denmark, 4600, Denmark

Location

Department of Anaesthesiology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Interventions

Sodium Chloride; Dexamethasone; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mathias Maagaard, MD

  Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Trial medication will be prepared by unmasked personnel who are not otherwise involved in the trial. The participant, personnel, caregivers, investigators, outcome assessors, and data analysts will be masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, blinded, placebo-controlled, parallel clinical trial

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: June 2, 2021
• Primary Completion: April 17, 2023
• Study Completion: May 17, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When the trial has been completed, data analysed, and trials results published.
• Access Criteria: Individual patient data in anonymised form will be shared upon reasonable request to the primary investigator.

Locations

DK (2)