The effects of combined use of dexamethasone (corticosteroid) and dexmedetomidine (sedative) on a nerve block in patients undergoing surgery of the bones in the foot and ankle.

Combined intravenous dexamethasone and dexmedetomidine as adjuncts to popliteal and saphenous nerve blocks in patients undergoing orthopaedic surgery of the foot and ankle. A randomised, blinded, placebo-controlled, parallel clinical trial.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000429-28-DK

Enrollment

120

Registered

2021-02-19

Start date

2021-04-21

Completion date

Unknown

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants undergoing osseous surgery of the foot or ankle with a popliteal and saphenous nerve blocks as means of providing anagelsia with general anaesthesia will be investigated. MedDRA version: 20.0 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865

Interventions

Trade Name: Dexmedetomidine Pharmaceutical Form: Solution for infusion INN or Proposed INN: Dexmedetomidine CAS Number: 145108-58-3 Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 or use of safe anti-conception. Ability to understand the trial protocol, risks, benefits, and provide signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Inability to read and understand Danish. Uncooperativeness. 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. 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.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Time to first pain (measured in minutes);Timepoint(s) of evaluation of this end point: Evaluated by the participant continously as the time to the first perceived pain in the surgical area. An investigator will contact the participant daily. Maximal follow-up 72 hours.;Main Objective: To assess the effects of combined intravenous dexamethasone and dexmedetomidine as adjuncts to popliteal and saphenous nerve blocks in participants undergoing surgery of the ankle or foot.;Secondary Objective: Not applicable.	—

Measure

Time frame

Primary end point(s): Time to first pain (measured in minutes);Timepoint(s) of evaluation of this end point: Evaluated by the participant continously as the time to the first perceived pain in the surgical area. An investigator will contact the participant daily. Maximal follow-up 72 hours.;Main Objective: To assess the effects of combined intravenous dexamethasone and dexmedetomidine as adjuncts to popliteal and saphenous nerve blocks in participants undergoing surgery of the ankle or foot.;Secondary Objective: Not applicable.

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Secondary

Measure	Time frame
Secondary end point(s): Duration of the motor block (measured in minutes, defined as the time to first contraction of the calf muscles on the operative side). Quality of sleep (measured on the Numerical Rating Scale from 0 to 10 points). Number of participants with one or more adverse events. Number of participants with one or more serious adverse events (according to the ICH-GCP). Cumulative oxycodone consumption, Pain (measured on the Numerical Rating Scale from 0 to 10 points).;Timepoint(s) of evaluation of this end point: Quality of sleep will be evaluated after the first, second, and third postoperative night. Cumulative oxycodone consumption will partly be recorded continuously during hospitalisation and after discharge for the first 72 hours postoperatively. Maximal follow-up for outcomes is 72 hours. However, serious adverse events will also be assessed 30 days postoperatively.	—

Measure

Time frame

Secondary end point(s): Duration of the motor block (measured in minutes, defined as the time to first contraction of the calf muscles on the operative side). Quality of sleep (measured on the Numerical Rating Scale from 0 to 10 points). Number of participants with one or more adverse events. Number of participants with one or more serious adverse events (according to the ICH-GCP). Cumulative oxycodone consumption, Pain (measured on the Numerical Rating Scale from 0 to 10 points).;Timepoint(s) of evaluation of this end point: Quality of sleep will be evaluated after the first, second, and third postoperative night. Cumulative oxycodone consumption will partly be recorded continuously during hospitalisation and after discharge for the first 72 hours postoperatively. Maximal follow-up for outcomes is 72 hours. However, serious adverse events will also be assessed 30 days postoperatively.

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Countries

Denmark

Contacts

Public ContactDepartment of Anaesthesiology

Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark

mmaag@regionsjaelland.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026