We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nerve Block for Pain Control After Fracture Surgery

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05391464
Recruitment Status : Recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Stuart A Aitken, MaineGeneral Health

Brief Summary:
Surgical treatment for patients with a fracture of the ankle or distal radius is commonly offered on an outpatient basis. Patients are routinely discharged from hospital within 4 hours of their procedure. The surgery is commonly performed under peripheral nerve block with sedation, or under general anesthesia with postoperative peripheral nerve block, (if required for analgesic purposes). It is unclear which of these two strategies offers patients superior pain relief in the first few days following surgery. This trial aims to compare the pain intensity and analgesic medication consumption between patients in these two groups.

Condition or disease Intervention/treatment Phase
Ankle Fractures Distal Radius Fracture Procedure: Peripheral Nerve Block Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, single-center, superiority
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Versus Postoperative Peripheral Nerve Block for Pain Control After Ankle and Wrist Fracture Surgery
Actual Study Start Date : May 16, 2022
Estimated Primary Completion Date : May 18, 2025
Estimated Study Completion Date : June 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: Peripheral Nerve Block
Participants will receive an ultrasound-guided, single shot PNB using 30ml 0.5% bupivacaine with 10mg dexamethasone. The anatomic location of the block will be determined by the anesthesiologist and will vary according to fracture location and anticipated surgical approaches. Intraoperative sedation will be used at the discretion of the anesthetic team.
Procedure: Peripheral Nerve Block
Utilized preoperatively with sedation during surgery, or postoperatively for additional anesthesia after GA.

Active Comparator: General Anesthesia +/- PNB
GA will be administered in the operating room by a nurse anesthetist, with support from the anesthesiologist. GA will be induced with propofol and fentanyl and maintained with sevoflurane or desflurane and fentanyl. Doses will be determined by the anesthesiology team.
Procedure: Peripheral Nerve Block
Utilized preoperatively with sedation during surgery, or postoperatively for additional anesthesia after GA.




Primary Outcome Measures :
  1. Pain 24 hours [ Time Frame: 24 hours postop ]
    Patient-rated measure, 0-10 visual analogue scale


Secondary Outcome Measures :
  1. Pain 12 hours [ Time Frame: 12 hours postop ]
    0-10 visual analogue scale

  2. Nausea and Vomiting 24 hours [ Time Frame: 24 hours postop ]
    0-10 visual analogue scale

  3. Pain Functional Activity Scale 24 hours [ Time Frame: 24 hours postop ]
    A - No limitation, minimal pain; B - Mild limitation, moderate to severe pain; C - Severe limitation, can't perform due to severe pain. Four domains: Getting dressed, Preparing food, Moving around, Sleeping

  4. Pain Functional Activity Scale 48 hours [ Time Frame: 48 hours postop ]
    A - No limitation, minimal pain; B - Mild limitation, moderate to severe pain; C - Severe limitation, can't perform due to severe pain. Four domains: Getting dressed, Preparing food, Moving around, Sleeping

  5. Pain 48 hours [ Time Frame: 48 hours postop ]
    0-10 visual analogue scale


Other Outcome Measures:
  1. Analgesic consumption [ Time Frame: 24 hours, 48 hours, 72 hours postop ]
    Total milligram morphine equivalents, and nonopioid analgesics

  2. Rebound pain [ Time Frame: First 72 hours postop ]
    Proportion of participants experiencing rebound pain (defined as visual analogue scale pain of 3 or less, climbing to 7 or more) after PNB.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Within 2 weeks of injury
  • Isolated fracture requiring surgery
  • Outpatient

Exclusion Criteria:

  • Multiple fractures
  • Inpatients
  • Cognitive impairment
  • Unable to comply with follow-up
  • No means of telephone contact
  • Contraindication to peripheral nerve block

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): NCT05391464


Contacts
Layout table for location contacts
Contact: Stuart A Aitken, MBChB MD 2076218700 stuart.aitken@mainegeneral.org

Locations
Layout table for location information
United States, Maine
MaineGeneral Medical Center Recruiting
Augusta, Maine, United States, 04330
Contact: Stuart A Aitken, MBChB MD    207-621-8700    stuart.aitken@mainegeneral.org   
Sponsors and Collaborators
MaineGeneral Health
Publications:

Layout table for additonal information
Responsible Party: Stuart A Aitken, Principal Investigator, MaineGeneral Health
ClinicalTrials.gov Identifier: NCT05391464    
Other Study ID Numbers: PNBtrial
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Radius Fractures
Ankle Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries