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

September 18, 2020 updated by: Anne Holmberg, Oslo University Hospital

Rebound Pain at Block Resolution 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0540
        • Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences between groups in highest pain scores first 24 hours after surgery
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks
Time Frame: 36 hours, 3 days, 7 days, 6 weeks
36 hours, 3 days, 7 days, 6 weeks
Differences in pain scores after 6 months and 1 year
Time Frame: 6 months and 1 year
6 months and 1 year
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
1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year
Differences in block duration
Time Frame: 20 hours
20 hours
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
30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in sleep quality assessed with Likert scale
Time Frame: 24 hours
Likert scale
24 hours
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
30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
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
30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
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
30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences in time to first pain score under 4 after block resolution
Time Frame: 7 days
7 days
Differences in side effects
Time Frame: 1 year
1 year
Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

April 5, 2019

Study Completion (Actual)

April 5, 2020

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/599/REK sør-øst C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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