Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery

Colorectal Neoplasms Clinical Trial

— AcuPONV  

Official title:

High-dose Acupuncture for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Colorectal Surgery: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509143
• Other study ID #: 03-2015-010
• Status: Completed
• Phase: N/A
• First received: July 17, 2015
• Last updated: March 7, 2017
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: This study aims to assess the effectiveness, safety, and feasibility of intensive acupuncture treatments combined with standard antiemetic medication as compared with P6 acupoint stimulation combined with standard antiemetic medication or with standard antiemetic medication alone, to prevent postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic colorectal surgery.

Background: PONV is one of the prevalent discomforts in the early phase of recovery after surgery. Evidence suggests that the stimulation of the P6 acupuncture point can reduce the occurrence of PONV. What remains unclear is whether a higher dose of acupuncture produces more benefits compared with P6 stimulation alone or whether acupuncture combined with standard antiemetic medication yields better outcomes. This study aims to assess the effectiveness and safety of different acupuncture regimen for the prevention of PONV: high-dose acupuncture treatments combined with standard antiemetic medication, P6 acupuncture-point stimulation combined with standard antiemetic medication, or medication alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective laparoscopic surgery of colorectal cancer resection (right hemicolectomy, left hemicolectomy, anterior resection with primary anastomosis, and low anterior resection with loop ileostomy for fecal diversion)

• Patients aged 18 to 80

• American Society of Anesthesiologists Grade 1 to 2

• Written informed consents

Exclusion Criteria:

• Pregnancy

• Inflammatory bowel disease

• Comorbidities that may affect outcomes of surgery (e.g., chronic kidney disease, chronic liver disease, cardiopulmonary failure, and diabetes with complications)

• Use of emetogenic / antiemetic medication within 24 hours before surgery

• Previous history of emetic episodes after administration of antibiotics

• Expected use of mechanical ventilation

• Cognitive impairment that may affect the patient's ability to complete the outcome assessments

• Previous history of stroke

• Previous history of sensitive reaction to acupuncture

• Patients unable to cooperate with acupuncture treatments

• Pacemaker implantation

• Previous history of epilepsy

• Patients who have received Korean medicine treatments (acupuncture, moxibustion, cupping, or herbal medicine) within 2 weeks

• Patients who have participated in other trials within 3 months

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Procedure:
• High-dose acupuncture with intravenous infusion of ramosetron
Three sessions of acupuncture will be provided within 48 hours after surgery. Electrical stimulation with an alternating frequency of 2 to 100 Hz will be applied to selected points (PC6 to LI4, ST36 to ST37, and bilateral SP6). An embedded acupuncture technique for preoperative anxiety will be applied to the bilateral acupuncture points of Liver (LI4), Heart 7 (HT7), Stomach (ST36), Yin-Tang, ear Shen-Men,and ear sympathetic and will be removed the next day. Treatments will be provided by qualified hospital staff (Korean medical doctors) with more than 10 years of clinical experience. The same stimulation of P6 points and antiemetics will be provided to the P6 acupuncture-point stimulation group.

Device:
• P6 stimulation with intravenous infusion of ramosetron
Stimulation of P6 points will be maintained from one hour before and for 48 hours after surgery by wearing a wristband that produces pulse-type transcutaneous electrical stimulation. Antiemetics will be provided, the same as the standard antiemetic medication alone group.

Drug:
• Intravenous infusion of ramosetron
Intravenous infusion of (oxycodone 20mg, ketorolac 120mg, ramosetron 0.3mg) as standard antiemetic medication will be provided. A dose of continuous infusion will be reduced by 0.1 ml/hr when a patient complaints of nausea. When vomiting occurs, a dose of continuous infusion will be reduced by 0.2 ml/hr and a bolus infusion of ramosetron 0.3 mg will be provided. A bolus infusion of ramosetron 0.3 mg will be also given if a patient feels greater than or equal to six points of nausea as measured on a 0 to 10 numeric rating scale (NRS) (nausea-severity scale) or by the patient's request, regardless of the severity of the nausea.

Locations

Country	Name	City	State
Korea, Republic of	National Clinical Research Center, Korean Medicine Hospital, Pusan National University	Yangsan	Kyung Sang South Province
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Kyung Sang South Province

Sponsors (3)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital	Korea Institute of Oriental Medicine, Korean Medicine Hospital of Pusan National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who experience moderate or severe level nausea or vomiting	Number of patients who experience moderate or severe level nausea (i.e, at least 4 points of nausea on 0 to 10 numeric rating scale) or vomiting during the first 24 postoperative hours	at 24 hours after surgery
Secondary	Nausea scores on a numeric rating scale	Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)	at baseline (the discharge of recovery room), 6, 12, 24, 48 hours from baseline and at discharge (until discharge, an expected average of 7 days after surgery)
Secondary	Number of vomiting		from the discharge of recovery room to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 hours to the discharge (until discharge, an expected average of 7 days after surgery)
Secondary	Cumulative incidence of vomiting		at baseline to 24 and 48 hours
Secondary	Number of patients who experience nausea		from the discharge of recovery room to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 hours to the discharge (until discharge, an expected average of 7 days after surgery)
Secondary	Cumulative number of patients who experience nausea		at baseline to 24 and 48 hours
Secondary	Number of patients who experience vomiting		from the discharge of recovery room to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 hours to the discharge (until discharge, an expected average of 7 days after surgery)
Secondary	Pain scores on a numeric rating scale	Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)	at 6, 12, 24, 48 hours from the discharge of recovery room and at discharge (until discharge, an expected average of 7 days after surgery)
Secondary	Patient's global assessment of recovery after surgery	Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.	at 2 weeks after surgery
Secondary	Time to first flatus		until discharge, an expected average of 7 days after surgery
Secondary	Time to tolerate soft diet		until discharge, an expected average of 7 days after surgery
Secondary	Time to first defecation		until discharge, an expected average of 7 days after surgery
Secondary	Time to independent walk		until discharge, an expected average of 7 days after surgery
Secondary	Number of insertions of nasogastric tube		until discharge, an expected average of 7 days after surgery
Secondary	Time to first removal of Foley catheter		until discharge, an expected average of 7 days after surgery
Secondary	Number of reinsertions of Foley catheter		until discharge, an expected average of 7 days after surgery
Secondary	Number of clean intermittent catheterizations		until discharge, an expected average of 7 days after surgery
Secondary	Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30		at 2 weeks after surgery
Secondary	Preoperative anxiety	measured by 0 to 10 numeric rating scale (0: no anxiety, 10: extreme anxiety)	just before the induction of anaesthesia
Secondary	Patient-reported satisfaction for management of PONV	measured by 0 to 10 numeric rating scale (0: very unsatisfactory, 10: very satisfactory)	at 48 hours after surgery
Secondary	Use of medication		at 2 weeks after surgery
Secondary	Postoperative complications	wound infection; urinary tract infection; urinary retention; chest infection; other infection; paralytic ileus	within 4 weeks after surgery
Secondary	Serious adverse events	respiratory failure requiring ventilation; renal failure requiring dialysis; cardiac failure; myocardial infarction; anastomotic leakage requiring surgery; anastomotic leakage requiring drainage; bowel obstruction/stricture requiring surgery; abdominal wall dehiscence requiring surgery; readmission within 30 days after surgery; reoperation within 30 days after surgery; mortality during surgery or within 30 days after surgery	within 4 weeks after surgery