Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

Auricular Acupuncture As Part Of A Multimodal Analgesic Regimen For Reduction Of Opioid Analgesic Use After Surgery To Repair Lower Leg Fractures- A Randomized Controlled Trial

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05984433

Enrollment

Registered

2023-08-09

Start date

2025-12-11

Completion date

2026-12-31

Last updated

2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Fracture, Fracture, Ankle, Pain, Postoperative, Pilon Fracture of Tibia

Brief summary

The purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce postoperative opioid use.

Interventions

DEVICEAuricular acupuncture

Electro auricular acupuncture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

The patient will be under sedation during procedure, so will not be aware of whether or not they received acupuncture treatment. Anesthesia team in the operating room will be aware of treatment. PACU team and outcomes assessor will not be aware of group assignment

Intervention model description

Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

1. Patient ages 18-64 2. American Society of Anesthesiology Physical Status I, II or III 3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital

Exclusion criteria

1. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications 2. Allergy to any of the standard anesthetic agents 3. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder) 4. Patient or surgeon refusal

Design outcomes

Primary

Measure	Time frame	Description
Total opioid analgesic use for 14 days after surgery	14 days	Total opioid given in hospital and taken at home, converted to oral morphine equivalents

Secondary

Measure	Time frame	Description
Pain scores	14 days	Pain scores (1-10) in PACU and at the 7 and 14 day mark post surgery
Incidence of side effects associated with opioid use	14 days	PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026