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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03011905
Recruitment Status : Active, not recruiting
First Posted : January 5, 2017
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Anne Holmberg, Oslo University Hospital

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
Brachial Plexus Block Pain, Postoperative Drug: Dexamethasone Drug: NaCl (Control) Drug: Paracetamol Drug: EtoriCoxib Drug: Oxycodone Drug: Ropivacaine 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2017
Estimated Primary Completion Date : April 5, 2019
Estimated Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexamethasone
Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.
Drug: Dexamethasone
4 ml DexaGalen 4 mg/ml
Other Name: DexaGalen

Drug: Paracetamol
Premedication and as needed after operation

Drug: EtoriCoxib
Premedication and first 2 postoperative days.
Other Name: 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 Name: NaCl

Drug: Paracetamol
Premedication and as needed after operation

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

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

Drug: Ropivacaine
In brachial plexus block




Primary Outcome Measures :
  1. Differences between groups in highest pain scores first 24 hours after surgery [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011905


Locations
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Norway
Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten
Oslo, Norway, 0540
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Anne Holmberg, MD Oslo University Hospital

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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: January 5, 2017    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pain, Postoperative
Radius Fractures
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Forearm Injuries
Arm Injuries
Wounds and Injuries
Fractures, Bone
Dexamethasone
Dexamethasone acetate
Etoricoxib
Oxycodone
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors