Clinical trial NCT02940288: Acupuncture for Postoperative Analgesia in Laparoscopic Surgery
Official title: Acupuncture for Postoperative Analgesia in Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to First Analgesic Request
timeFrame: Post Surgery (Up to 30 minutes)
measure: Total Amount of Postoperative Pain Medication
timeFrame: Post Surgery (Up to 2 Hours)
measure: Pain Intensity assessed by the Visual Analog Scale (VIS)
timeFrame: Post Surgery (Up to 2 Hours)
Secondary outcomes:
measure: Time to Discharge
timeFrame: Post Surgery (Up to 2 Hours)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Veterans Affairs (VA) Medical Center
state: Georgia
Study officials:
affiliation: Emory University
name: Yanire Nieves, MD
role: PRINCIPAL_INVESTIGATOR
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