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NCT Number: NCT03011905

Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block

Many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. This study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The primary endpoint is difference in the highest pain score first 24 hours after surgery. The investigators will also look at pain scores and analgesics consumption first few hours after surgery and at different times up to 2 years after surgery.

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Key information

Conditions

Brachial Plexus Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten

Oslo, 0540, Norway

About this study

This double-blind randomized clinical study evaluates pain, analgesic consumption and different measurements of patients satisfaction after operations for distal radius fractures with a volar plate in the day-care surgery unit. All patients will receive paracetamol and etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a single dose of 16 mg dexamethasone during the operation. Patients in the control group will receive NaCl iv.

After surgery, iv and oral rapid release oxycodone as needed while in hospital. After discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3 doses. Rapid release oxycodone as needed.

Patients will be followed up by telephone interviews at different times after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Distal radius fracture planned for operation with a volar plate
  • 0-20 days after trauma
  • AO classification A, B, and C
  • ASA 1 and 2
  • Age 18-65
  • BMI 18-35
  • Able to communicate in Norwegian

Exclusion criteria

  • Chronic pain
  • Other injuries
  • Pregnancy
  • Known allergic reactions to medicines used in the study

Treatment and study plan

Dexamethasone

Drug

4 ml DexaGalen 4 mg/ml

Other names: DexaGalen

NaCl (Control)

Drug

4 ml NaCl 9 mg/ml

Other names: NaCl

Paracetamol

Drug

Premedication and as needed after operation

Etoricoxib

Drug

Premedication and first 2 postoperative days.

Other names: Arcoxia

Oxycodone

Drug

Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.

Other names: OxyContin, OxyNorm

Ropivacaine

Drug

In brachial plexus block

Primary outcomes

  1. Differences between groups in highest pain scores first 24 hours after surgery

    Time frame: 24 hours

Secondary outcomes

  1. Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours

    Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours

  2. Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks

    Time frame: 36 hours, 3 days, 7 days, 6 weeks

  3. Differences in pain scores after 6 months and 1 year

    Time frame: 6 months and 1 year

  4. Differences in analgesic consumption

    Time frame: 1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year

  5. Differences in block duration

    Time frame: 20 hours

  6. Differences between groups in sedation postoperatively assessed with Likert scale

    Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours

    Likert scale

  7. Differences between groups in sleep quality assessed with Likert scale

    Time frame: 24 hours

    Likert scale

  8. Differences between groups in nausea postoperatively assessed with Likert scale

    Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours

    Likert scale

  9. Differences between groups in vomiting postoperatively assessed with Likert scale

    Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours

    Likert scale

  10. Differences between groups in itching postoperatively assessed with Likert scale

    Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours

    Likert scale

  11. Differences in time to first pain score under 4 after block resolution

    Time frame: 7 days

  12. Differences in side effects

    Time frame: 1 year

  13. Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 5, 2017
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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