Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture
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ClinicalTrials.gov Identifier: NCT05984433 |
Recruitment Status :
Recruiting
First Posted : August 9, 2023
Last Update Posted : October 11, 2023
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Condition or disease | Intervention/treatment | Phase |
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Pain, Postoperative Fracture, Ankle Pilon Fracture of Tibia Foot Fracture | Device: Auricular acupuncture | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group |
Masking: | Double (Participant, 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 |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | October 9, 2023 |
Estimated Primary Completion Date : | October 2024 |
Estimated Study Completion Date : | October 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Electroauricular acupuncture
Immediately after Level 2 sedation is achieved, an enhanced auricular trauma protocol (ATP) will be administered on the ear ipsilateral to the operative side at 8 ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) as described by Cheng (2022). The original ATP was described by Helms (2011). Seirin L 0.2 x 30 mm needles will be placed at Hypothalamus and Shen Men points. Seirin J 0.18 x 15 mm needles will be placed at Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Vagus, and Insula points. Electrostimulation using an ITO ES 130 microstimulator at 30 HZ with Level 4 intensity, will be applied with the positive lead (red) on Hypothalamus and negative lead (black) at Shen Men for 60 minutes. All needles will be removed 1 hour after insertion.
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Device: Auricular acupuncture
Electro auricular acupuncture |
No Intervention: No acupuncture
No acupuncture treatment given
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- Total opioid analgesic use for 14 days after surgery [ Time Frame: 14 days ]Total opioid given in hospital and taken at home, converted to oral morphine equivalents
- Pain scores [ Time Frame: 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 [ Time Frame: 14 days ]PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth
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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient ages 18-64
- American Society of Anesthesiology Physical Status I, II or III
- Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital
Exclusion Criteria:
- Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
- Allergy to any of the standard anesthetic agents
- Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
- Patient or surgeon refusal
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): NCT05984433
Contact: Jaime Ortiz, MD, MBA | 713-873-2860 | jaimeo@bcm.edu |
United States, Texas | |
Ben Taub Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Jaime Ortiz, MD,MBA 713-873-2860 jaimeo@bcm.edu | |
Principal Investigator: Jaime Ortiz, MD, MBA |
Responsible Party: | Jaime Ortiz, Professor of Anesthesiology, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT05984433 |
Other Study ID Numbers: |
H-53820 |
First Posted: | August 9, 2023 Key Record Dates |
Last Update Posted: | October 11, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Pain, Postoperative Fractures, Bone Tibial Fractures Ankle Fractures Wounds and Injuries Postoperative Complications |
Pathologic Processes Pain Neurologic Manifestations Leg Injuries Ankle Injuries |