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Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular acupuncture
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ben Taub HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Electroauricular acupuncture

No acupuncture

Arm Description

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.

No acupuncture treatment given

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2023
Last Updated
October 9, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05984433
Brief Title
Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Fracture, Ankle, Pilon Fracture of Tibia, Foot Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group
Masking
ParticipantOutcomes 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
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroauricular acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
No acupuncture
Arm Type
No Intervention
Arm Description
No acupuncture treatment given
Intervention Type
Device
Intervention Name(s)
Auricular acupuncture
Intervention Description
Electro auricular acupuncture
Primary Outcome Measure Information:
Title
Total opioid analgesic use for 14 days after surgery
Description
Total opioid given in hospital and taken at home, converted to oral morphine equivalents
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Pain scores
Description
Pain scores (1-10) in PACU and at the 7 and 14 day mark post surgery
Time Frame
14 days
Title
Incidence of side effects associated with opioid use
Description
PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Ortiz, MD, MBA
Phone
713-873-2860
Email
jaimeo@bcm.edu
Facility Information:
Facility Name
Ben Taub Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Ortiz, MD,MBA
Phone
713-873-2860
Email
jaimeo@bcm.edu
First Name & Middle Initial & Last Name & Degree
Jaime Ortiz, MD, MBA

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

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