Acupuncture for Postoperative Analgesia in Laparoscopic Surgery

Study Overview
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Brief Summary
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Auricular (ear) acupuncture treatment involves placing filiform needles in the ears at particular locations called acupoints. Although the mechanism for acupuncture analgesia is still unclear, it is believed ear acupoints work like reflex points that once stimulated with penetration by a needle have the ability to relieve pain in a different part of the body. The purpose of this study is to explore the safety and effects of auricular acupuncture therapy on postoperative analgesic consumption and pain scores immediately following laparoscopic surgery.

Detailed Description
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Auricular acupuncture is a diagnostic and treatment system associated with a somatotopic representation of the homunculus in the ear. This acupuncture technique is similar, in theory, to reflexology where stimulation of a reflex point in the ear is presumed to relieve symptoms in another part of the body. It is hypothesized that this technique works to decrease pain through the reticular formation, the sympathetic and the parasympathetic nervous systems. The increasing use of laparoscopic surgery has significantly diminished the dosing and duration of postoperative opioid consumption compared with open surgery. However, adverse events related with opioid use (nausea & vomiting, pruritus, urinary retention, sedation) may cause delays in hospital discharge and can be especially problematic for certain sub-sets of high risk patients such as those with obstructive sleep apnea or prior histories of addiction. Investigators hypothesize that auricular acupuncture using the Battlefield Acupuncture Protocol will decrease opioid consumption and postoperative pain after laparoscopic surgery with minimal or no adverse events. The primary aim of this study is to assess the effects of the BFA protocol on postoperative analgesic consumption and the secondary aims are to assess pain scores and time to discharge from Post Anesthesia Care Unit following laparoscopic surgery.

Official Title
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Acupuncture for Postoperative Analgesia in Laparoscopic Surgery

Conditions
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Surgery

Intervention / Treatment
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* Other: Auricular Acupuncture
* Other: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing laparoscopic surgery for cholecystectomy, hysterectomy or hernia repair Patients naïve to acupuncture Exclusion Criteria: Pregnancy Bleeding disorder Anticoagulant medications Involuntary movement disorders/Seizure disorders Local auricular infection, loss of skin integrity or significant deformation History of opioid medication use or dependence Hemodynamic or immunocompromised status History of syncope with venipuncture Unable to understand the consent form or how to use the VAS-100 Prosthetic cardiac valves Patients will be withdrawn from the study if surgery time exceeds 90 minutes or the laparoscopic procedure turned into an open surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will be randomized to receive bilateral auricular acupuncture for postoperative pain. | Other: Auricular Acupuncture<br>* Participants will receive bilateral auricular acupuncture using the Battlefield Acupuncture (BFA) protocol while in the Post Analgesia Care Unit (PACU) following laparoscopic surgery. Acupuncture needles will be left in place for 30 minutes.<br>|
| Sham Comparator: Control<br>Participants will be randomized to receive bilateral sham acupuncture. | Other: Sham Acupuncture<br>* Participants will receive sham acupuncture while in the Post Analgesia Care Unit (PACU) following laparoscopic surgery. During the sham procedure, needles will be inserted bilaterally in five nonspecific ear acupoints. Acupuncture needles will be left in place for 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Analgesic Request | The time to request for analgesia will be collected from the participant's postoperative anesthesia care unit (PACU) records. | Post Surgery (Up to 30 minutes) | 
| Total Amount of Postoperative Pain Medication | The total amount of pain medication taken up to two hours post surgery will be collected from the participant's postoperative anesthesia care unit (PACU) records. | Post Surgery (Up to 2 Hours) | 
| Pain Intensity assessed by the Visual Analog Scale (VIS) | Pain intensity will be recorded using the modified 100mm visual analog scale. This scale rates pain from 0 to 100 with 0 meaning no pain at all and 100 is the most severe pain. | Post Surgery (Up to 2 Hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Discharge | Time to discharge from the postoperative anesthesia care unit (PACU) will be collected from the participant's record. | Post Surgery (Up to 2 Hours) |