Recruiting

Nerve Block

Sponsor:

MaineGeneral Health

Code:

NCT05391464

Conditions

Ankle Fractures

Distal Radius Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Peripheral Nerve Block

Study Details

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.

Conditions

Ankle Fractures

Distal Radius Fracture

Study ID

NCT05391464

Start date

May 16, 2022

Status verified date

May, 2022

Completion date

Jun 18, 2025

Anticipated

Primary completion date

May 18, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Peripheral Nerve Block

Utilized preoperatively with sedation during surgery, or postoperatively for additional anesthesia after GA.

Primary outcome measure

  • Pain 24 hours [ Time Frame: 24 hours postop ]

Central Contacts and Locations

Central contacts

Stuart A Aitken, MBChB MD

2076218700stuart.aitken@mainegeneral.org

Locations

MaineGeneral Medical Center

Recruiting

Augusta, Maine, United States, 04330

Contacts

Stuart A Aitken, MBChB MD

207-621-8700stuart.aitken@mainegeneral.org

More Information

Sponsor

MaineGeneral Health

Last update posted

May 26, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MaineGeneral Health on 2022-05-26.