Acupuncture for Postoperative Analgesia in Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Other: Auricular Acupuncture; Other: Sham Acupuncture

• Registration Number: NCT02940288
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients undergoing laparoscopic surgery for cholecystectomy, hysterectomy or hernia repair
• Patients naïve to acupuncture

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Auricular Acupuncture	Participants will be randomized to receive bilateral auricular acupuncture for postoperative pain.
Control	Sham Acupuncture	Participants will be randomized to receive bilateral sham acupuncture.

Primary Outcome Measures

Name	Time	Method
Time to First Analgesic Request	Post Surgery (Up to 30 minutes)	The time to request for analgesia will be collected from the participant's postoperative anesthesia care unit (PACU) records.
Total Amount of Postoperative Pain Medication	Post Surgery (Up to 2 Hours)	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.
Pain Intensity assessed by the Visual Analog Scale (VIS)	Post Surgery (Up to 2 Hours)	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.

Secondary Outcome Measures

Name	Time	Method
Time to Discharge	Post Surgery (Up to 2 Hours)	Time to discharge from the postoperative anesthesia care unit (PACU) will be collected from the participant's record.

Trial Locations

Locations (1)

Atlanta Veterans Affairs (VA) Medical Center; 🇺🇸 Atlanta, Georgia, United States