Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery (AcuPONV)

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

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.

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Postoperative Nausea and Vomiting
• Intervention / Treatment: Procedure: High-dose acupuncture with intravenous infusion of ramosetron; Device: P6 stimulation with intravenous infusion of ramosetron; Drug: Intravenous infusion of ramosetron

Detailed Description

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyung Sang South Province
    • Yangsan, Kyung Sang South Province, Korea, Republic of, 626-770
      • National Clinical Research Center, Korean Medicine Hospital, Pusan National University
    • Yangsan, Kyung Sang South Province, Korea, Republic of, 626-770
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-dose acupuncture with intravenous infusion of ramosetron; Three sessions of acupuncture on the points of Stomach 36 (ST36), Stomach 37 (ST37), Liver 3 (LR3), Large Intestine 11 (LI11), Large Intestine 4 (LI4), Spleen 6 (SP6), Spleen 4 (SP4), Pericardium 6 (PC6), Heart 8 (HT8), and Gall Bladder 41 (GB41) within 48 hours after surgery	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.; Other Names: Acupuncture; 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.; Other Names: PC6; 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.; Other Names: Antiemetics
Active Comparator: P6 stimulation with intravenous infusion of ramosetron; P6 stimulation by wearing a study wristband within 48 hours after surgery	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.; Other Names: PC6; 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.; Other Names: Antiemetics
Active Comparator: Intravenous infusion of ramosetron; A mixture of standard antiemetic medication (5-Hydroxytryptophan receptor antagonist; ramosetron hydrochloride 0.3 mg) and analgesics, including anon-steroidal anti-inflammatory drug (NSAID) (ketorolac tromethamine 120 mg), and a semi-synthesized opioid (oxycodone 20 mg), will be infused by intravenous patient-controlled analgesia (1ml bolus/20 min lockout, 1ml/hr continuous infusion).	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.; Other Names: Antiemetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
Preoperative anxiety	measured by 0 to 10 numeric rating scale (0: no anxiety, 10: extreme anxiety)	just before the induction of anaesthesia
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
Postoperative complications	wound infection; urinary tract infection; urinary retention; chest infection; other infection; paralytic ileus	within 4 weeks after surgery
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
Number of vomiting	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)
Cumulative incidence of vomiting	Cumulative incidence of vomiting	at baseline to 24 and 48 hours
Number of patients who experience nausea	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)
Cumulative number of patients who experience nausea	Cumulative number of patients who experience nausea	at baseline to 24 and 48 hours
Number of patients who experience vomiting	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)
Cumulative number of patients who experience vomiting	Cumulative number of patients who experience vomiting	at baseline to 24 and 48 hours
Time to first flatus	Time to first flatus	until discharge, an expected average of 7 days after surgery
Time to tolerate soft diet	Time to tolerate soft diet	until discharge, an expected average of 7 days after surgery
Time to first defecation	Time to first defecation	until discharge, an expected average of 7 days after surgery
Time to independent walk	Time to independent walk	until discharge, an expected average of 7 days after surgery
Number of insertions of nasogastric tube	Number of insertions of nasogastric tube	until discharge, an expected average of 7 days after surgery
Time to first removal of Foley catheter	Time to first removal of Foley catheter	until discharge, an expected average of 7 days after surgery
Number of reinsertions of Foley catheter	Number of reinsertions of Foley catheter	until discharge, an expected average of 7 days after surgery
Number of clean intermittent catheterizations	Number of clean intermittent catheterizations	until discharge, an expected average of 7 days after surgery
Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30	Quality of life measured by European Organization for Research and Treatment	at 2 weeks after surgery
Use of medication	Use of medication	at 2 weeks after surgery

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Collaborators: Korean Medicine Hospital of Pusan National University; Korea Institute of Oriental Medicine
• Investigators: Principal Investigator: Hee Young Kim, PhD, Pusan National University Yangsan Hospital

Publications and helpful links

General Publications

• Kim KH, Kim DH, Bae JM, Son GM, Kim KH, Hong SP, Yang GY, Kim HY. Acupuncture and PC6 stimulation for the prevention of postoperative nausea and vomiting in patients undergoing elective laparoscopic resection of colorectal cancer: a study protocol for a three-arm randomised pilot trial. BMJ Open. 2017 Jan 4;7(1):e013457. doi: 10.1136/bmjopen-2016-013457.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimated): July 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative Nausea and Vomiting; Colorectal Neoplasms
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Signs and Symptoms, Digestive; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Nausea; Vomiting; Colorectal Neoplasms; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Antiemetics; Ramosetron
• Other Study ID Numbers: 03-2015-010