Clincosm LogoSign in Get a demo

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

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03011905
Collaborator
(none)
53
Enrollment
1
Location
2
Arms
39.1
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Apr 5, 2019
Actual Study Completion Date :
Apr 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexamethasone

Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.

Drug: Dexamethasone
4 ml DexaGalen 4 mg/ml
Other Names:
  • DexaGalen

    • Drug: Paracetamol
    Premedication and as needed after operation

    Drug: EtoriCoxib
    Premedication and first 2 postoperative days.
    Other Names:
  • Arcoxia

    • Drug: Oxycodone
    Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.
    Other Names:
  • OxyContin
  • OxyNorm

    • Drug: Ropivacaine
    In brachial plexus block
    Placebo Comparator: Control

    Single dose of NaCl, 4 ml, iv during operation.

    Drug: NaCl (Control)
    4 ml NaCl 9 mg/ml
    Other Names:
  • NaCl

    • Drug: Paracetamol
    Premedication and as needed after operation

    Drug: EtoriCoxib
    Premedication and first 2 postoperative days.
    Other Names:
  • Arcoxia

    • Drug: Oxycodone
    Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.
    Other Names:
  • OxyContin
  • OxyNorm

    • Drug: Ropivacaine
    In brachial plexus block

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours [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 [36 hours, 3 days, 7 days, 6 weeks]

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

    4. Differences in analgesic consumption [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 [20 hours]

    6. Differences between groups in sedation postoperatively assessed with Likert scale [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 [24 hours]

      Likert scale

    8. Differences between groups in nausea postoperatively assessed with Likert scale [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 [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 [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 [7 days]

    12. Differences in side effects [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten Oslo Norway 0540

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

    • Principal Investigator: Anne Holmberg, MD, Oslo University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anne Holmberg, Principal investigator, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT03011905
    Other Study ID Numbers:
    • 2016/599/REK sør-øst C
    First Posted:
    Jan 5, 2017
    Last Update Posted:
    Sep 21, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Radius Fractures
    Acetaminophen
    Dexamethasone
    Etoricoxib
    Oxycodone
    Ropivacaine

    Study Results

    No Results Posted as of Sep 21, 2020