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

Primary Purpose

Brachial Plexus Block, Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Dexamethasone
NaCl (Control)
Paracetamol
EtoriCoxib
Oxycodone
Ropivacaine
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brachial Plexus Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Differences in pain scores after 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
Differences in pain scores after 6 months and 1 year
Differences in analgesic consumption
Differences in block duration
Differences between groups in sedation postoperatively assessed with Likert scale
Likert scale
Differences between groups in sleep quality assessed with Likert scale
Likert scale
Differences between groups in nausea postoperatively assessed with Likert scale
Likert scale
Differences between groups in vomiting postoperatively assessed with Likert scale
Likert scale
Differences between groups in itching postoperatively assessed with Likert scale
Likert scale
Differences in time to first pain score under 4 after block resolution
Differences in side effects
Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks

Full Information

First Posted
December 21, 2016
Last Updated
September 18, 2020
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03011905
Brief Title
Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
Official Title
Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brachial Plexus Block, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Single dose of NaCl, 4 ml, iv during operation.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
DexaGalen
Intervention Description
4 ml DexaGalen 4 mg/ml
Intervention Type
Drug
Intervention Name(s)
NaCl (Control)
Other Intervention Name(s)
NaCl
Intervention Description
4 ml NaCl 9 mg/ml
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
Premedication and as needed after operation
Intervention Type
Drug
Intervention Name(s)
EtoriCoxib
Other Intervention Name(s)
Arcoxia
Intervention Description
Premedication and first 2 postoperative days.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
OxyContin, OxyNorm
Intervention Description
Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
In brachial plexus block
Primary Outcome Measure Information:
Title
Differences between groups in highest pain scores first 24 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
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
Title
Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks
Time Frame
36 hours, 3 days, 7 days, 6 weeks
Title
Differences in pain scores after 6 months and 1 year
Time Frame
6 months and 1 year
Title
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
Title
Differences in block duration
Time Frame
20 hours
Title
Differences between groups in sedation postoperatively assessed with Likert scale
Description
Likert scale
Time Frame
30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Title
Differences between groups in sleep quality assessed with Likert scale
Description
Likert scale
Time Frame
24 hours
Title
Differences between groups in nausea postoperatively assessed with Likert scale
Description
Likert scale
Time Frame
30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Title
Differences between groups in vomiting postoperatively assessed with Likert scale
Description
Likert scale
Time Frame
30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Title
Differences between groups in itching postoperatively assessed with Likert scale
Description
Likert scale
Time Frame
30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Title
Differences in time to first pain score under 4 after block resolution
Time Frame
7 days
Title
Differences in side effects
Time Frame
1 year
Title
Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Holmberg, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten
City
Oslo
ZIP/Postal Code
0540
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32472958
Citation
Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30.
Results Reference
derived

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

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