Acupuncture for Postoperative Analgesia in Laparoscopic Surgery

Surgery Clinical Trial

— Acu-Pilot  

Official title:

Acupuncture for Postoperative Analgesia in Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940288
• Other study ID #: IRB00086184
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 22, 2019

Study information

• Verified date: November 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Auricular Acupuncture
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.
• Sham Acupuncture
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.

Locations

Country	Name	City	State
United States	Atlanta Veterans Affairs (VA) Medical Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (16)

Bohnert AS, Ilgen MA, Galea S, McCarthy JF, Blow FC. Accidental poisoning mortality among patients in the Department of Veterans Affairs Health System. Med Care. 2011 Apr;49(4):393-6. doi: 10.1097/MLR.0b013e318202aa27. — View Citation

Compton WM, Jones CM, Baldwin GT. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. N Engl J Med. 2016 Jan 14;374(2):154-63. doi: 10.1056/NEJMra1508490. Review. — View Citation

Crespin DJ, Griffin KH, Johnson JR, Miller C, Finch MD, Rivard RL, Anseth S, Dusek JA. Acupuncture provides short-term pain relief for patients in a total joint replacement program. Pain Med. 2015 Jun;16(6):1195-203. doi: 10.1111/pme.12685. Epub 2015 Jan 13. — View Citation

Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138. Review. — View Citation

Goertz CM, Niemtzow R, Burns SM, Fritts MJ, Crawford CC, Jonas WB. Auricular acupuncture in the treatment of acute pain syndromes: A pilot study. Mil Med. 2006 Oct;171(10):1010-4. — View Citation

Gori L, Firenzuoli F. Ear acupuncture in European traditional medicine. Evid Based Complement Alternat Med. 2007 Sep;4(Suppl 1):13-6. doi: 10.1093/ecam/nem106. — View Citation

Grube T, Uhlemann C, Weiss T, Meissner W. [Influence of acupuncture on postoperative pain, nausea and vomiting after visceral surgery : a prospective, randomized comparative study of metamizole and standard treatment]. Schmerz. 2009 Aug;23(4):370-6. doi: 10.1007/s00482-009-0798-1. German. — View Citation

Han JS, Tang J, Ren MF, Zhou ZF, Fan SG, Qiu XC. Central neurotransmitters and acupuncture analgesia. Am J Chin Med. 1980 Winter;8(4):331-48. — View Citation

Han JS. Acupuncture and endorphins. Neurosci Lett. 2004 May 6;361(1-3):258-61. Review. — View Citation

Lewith GT, Machin D. On the evaluation of the clinical effects of acupuncture. Pain. 1983 Jun;16(2):111-127. doi: 10.1016/0304-3959(83)90202-6. Review. — View Citation

Sun Y, Gan TJ, Dubose JW, Habib AS. Acupuncture and related techniques for postoperative pain: a systematic review of randomized controlled trials. Br J Anaesth. 2008 Aug;101(2):151-60. doi: 10.1093/bja/aen146. Epub 2008 Jun 2. Review. — View Citation

Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10. Review. — View Citation

Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Pain. 2005 Apr;114(3):320-327. doi: 10.1016/j.pain.2004.08.021. — View Citation

Usichenko TI, Hermsen M, Witstruck T, Hofer A, Pavlovic D, Lehmann C, Feyerherd F. Auricular Acupuncture for Pain Relief after Ambulatory Knee Arthroscopy-A Pilot Study. Evid Based Complement Alternat Med. 2005 Jun;2(2):185-189. Epub 2005 May 11. — View Citation

Usichenko TI, Kuchling S, Witstruck T, Pavlovic D, Zach M, Hofer A, Merk H, Lehmann C, Wendt M. Auricular acupuncture for pain relief after ambulatory knee surgery: a randomized trial. CMAJ. 2007 Jan 16;176(2):179-83. — View Citation

Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)

External Links

•   Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health.
•   Design and Rationale of a Comparative Effectiveness Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated with Traumatic Brain Injury
•   Injury Prevention & Control: Opioid Overdose
•   Pain Management Opioid Safety: Educational Guide
•   Prescription Opioids and Heroin