Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

Opioid Use Clinical Trial

Official title:

Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825471
• Other study ID #: CES and Postoperative pain
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Tri-Service General Hospital
• Contact: Yi-hsuan Huang, MD
• Phone: +886-2-87927128
• Email: yixiun72[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cranial electrotherapy stimulation (CES) is a non-invasive intervention to treat anxiety, depression, insomnia, and pain. But clinical studies and applications of CES in relation to acute postoperative pain are few. tThe investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery.

Description:

Cranial electrotherapy stimulation (CES) is a non-invasive and safe intervention, transmitting microcurrents of brain stimulation and releasing various neurotransmitters such as endorphin and downstream hormones to modulate autonomic nervous system, as a result, for treating anxiety, depression, insomnia, and pain.

Acute postoperative pain annoys patients receiving surgery. Once acute postoperative pain is poorly controlled, it may result in adverse acute effects (i.e., physiologic and psychologic stress), chronic effects (i.e., delayed long-term recovery and chronic pain), and, in consequence, excess length of hospitalization and extra costs. Besides, inflammatory reactions mediated by immune system are formed after tissue injury (e.g. trauma, surgery, etc), release serial inflammatory cytokines and are related to pain signal transmission. However, clinical studies and applications of CES focus on management of chronic pain, modulation of mood and insomnia rather than acute postoperative pain in recent years.

The investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery. The investigators also collect blood samples before and after surgery for analysis of serum cytokines. Meanwhile, Bispectral IndexTM (BISTM) monitoring and Analgesia Nociception Index (ANI) are prescribed during the surgery not only for measuring of the effects of anesthetics and sedatives on the brain, but also evaluating perioperative analgesia. Thereby, the effectiveness of CES for management of acute postoperative pain may introduce clinicians for alternative application of pain control after surgery in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing colon cancer surgery

Exclusion Criteria:

• presence of an implantable device (e.g., pacemaker)

• pregnancy

• having a known mental illness (e.g., schizophrenia, mood disorder, bipolar disorder, etc.

• cancer of the head and neck or brain tumor or brain metastasis

• having delirium

Related Conditions & MeSH terms

• Cytokine
• Opioid Use
• Pain, Postoperative

Intervention

Procedure:
• electrotherapy
Cranial electrotherapy stimulation

Drug:
• Opioid Anesthetics
consumption of opioids during general anesthesia

Procedure:
• colon cancer surgery
laparoscopic colon cancer surgery

Locations

Country	Name	City	State
Taiwan	TriService General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Lee SH, Kim WY, Lee CH, Min TJ, Lee YS, Kim JH, Park YC. Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response. J Int Med Res. 2013 Dec;41(6):1788-95. doi: 10.1177/0300060513500749. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dosage of intraoperative anesthetics	The consumption of total amount of supplemental analgesics administered during colon cancer surgery	during surgery
Primary	Rescue analgesics	The consumption of total amount of rescue analgesics administered after colon cancer surgery	from the end of the surgery to postoperative 72 hours
Primary	Differences in Pain Intensity Between CES intervention and the control group	Pain assessment of NRS pain intensity scores and patient satisfaction assessed by the NRS through end of surgery to postoperative 72 hours	from the end of the surgery to postoperative 72 hours
Secondary	dosage of patient-controlled analgesia (PCA) consumption	postoperative PCA consumption	from the end of the surgery to postoperative 72 hours
Secondary	serum concentration of serum cytokine	proinflammatory and antiinflammatory cytokines (IL-1a, IL-2, IL-6, IL-7, TNF-a, IL-4, IL-10, IL-10, IL-1, TGF-b)	from the beginning of the surgery to postoperative 72 hours
Secondary	Number of Participants with CES and control groups	patient characteristics	during surgery