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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011905
• Other study ID #: 2016/599/REK sør-øst C
• Status: Completed
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: April 5, 2020

Study information

• Verified date: September 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 5, 2020
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brachial Plexus Block
• Pain, Postoperative
• Radius Fractures

Intervention

Drug:
• Dexamethasone
4 ml DexaGalen 4 mg/ml
• NaCl (Control)
4 ml NaCl 9 mg/ml
• Paracetamol
Premedication and as needed after operation
• EtoriCoxib
Premedication and first 2 postoperative days.
• Oxycodone
Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.
• Ropivacaine
In brachial plexus block

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences between groups in highest pain scores first 24 hours after surgery		24 hours
Secondary	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
Secondary	Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks		36 hours, 3 days, 7 days, 6 weeks
Secondary	Differences in pain scores after 6 months and 1 year		6 months and 1 year
Secondary	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
Secondary	Differences in block duration		20 hours
Secondary	Differences between groups in sedation postoperatively assessed with Likert scale	Likert scale	30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Secondary	Differences between groups in sleep quality assessed with Likert scale	Likert scale	24 hours
Secondary	Differences between groups in nausea postoperatively assessed with Likert scale	Likert scale	30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Secondary	Differences between groups in vomiting postoperatively assessed with Likert scale	Likert scale	30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Secondary	Differences between groups in itching postoperatively assessed with Likert scale	Likert scale	30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Secondary	Differences in time to first pain score under 4 after block resolution		7 days
Secondary	Differences in side effects		1 year
Secondary	Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks		6 weeks