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Completed

NCT Number: NCT02509143

Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing 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.

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Nausea Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Clinical Research Center, Korean Medicine Hospital, Pusan National University, Yangsan, Kyung Sang South Province, South Korea

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About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-dose acupuncture with intravenous infusion of ramosetron

Procedure

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

P6 stimulation with intravenous infusion of ramosetron

Device

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

Intravenous infusion of ramosetron

Drug

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

Primary outcomes

  1. Number of patients who experience moderate or severe level nausea or vomiting

    Time frame: at 24 hours after surgery

    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

Secondary outcomes

  1. Nausea scores on a numeric rating scale

    Time frame: 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)

    Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)

  2. Number of vomiting

    Time frame: 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)

    Number of vomiting

  3. Cumulative incidence of vomiting

    Time frame: at baseline to 24 and 48 hours

    Cumulative incidence of vomiting

  4. Number of patients who experience nausea

    Time frame: 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)

    Number of patients who experience nausea

  5. Cumulative number of patients who experience nausea

    Time frame: at baseline to 24 and 48 hours

    Cumulative number of patients who experience nausea

  6. Number of patients who experience vomiting

    Time frame: 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)

    Number of patients who experience vomiting

  7. Cumulative number of patients who experience vomiting

    Time frame: at baseline to 24 and 48 hours

    Cumulative number of patients who experience vomiting

  8. Pain scores on a numeric rating scale

    Time frame: 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)

    Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)

  9. Patient's global assessment of recovery after surgery

    Time frame: at 2 weeks after surgery

    Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.

  10. Time to first flatus

    Time frame: until discharge, an expected average of 7 days after surgery

    Time to first flatus

  11. Time to tolerate soft diet

    Time frame: until discharge, an expected average of 7 days after surgery

    Time to tolerate soft diet

  12. Time to first defecation

    Time frame: until discharge, an expected average of 7 days after surgery

    Time to first defecation

  13. Time to independent walk

    Time frame: until discharge, an expected average of 7 days after surgery

    Time to independent walk

  14. Number of insertions of nasogastric tube

    Time frame: until discharge, an expected average of 7 days after surgery

    Number of insertions of nasogastric tube

  15. Time to first removal of Foley catheter

    Time frame: until discharge, an expected average of 7 days after surgery

    Time to first removal of Foley catheter

  16. Number of reinsertions of Foley catheter

    Time frame: until discharge, an expected average of 7 days after surgery

    Number of reinsertions of Foley catheter

  17. Number of clean intermittent catheterizations

    Time frame: until discharge, an expected average of 7 days after surgery

    Number of clean intermittent catheterizations

  18. Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30

    Time frame: at 2 weeks after surgery

    Quality of life measured by European Organization for Research and Treatment

  19. Preoperative anxiety

    Time frame: just before the induction of anaesthesia

    measured by 0 to 10 numeric rating scale (0: no anxiety, 10: extreme anxiety)

  20. Patient-reported satisfaction for management of PONV

    Time frame: at 48 hours after surgery

    measured by 0 to 10 numeric rating scale (0: very unsatisfactory, 10: very satisfactory)

  21. Use of medication

    Time frame: at 2 weeks after surgery

    Use of medication

  22. Postoperative complications

    Time frame: within 4 weeks after surgery

    • wound infection
    • urinary tract infection
    • urinary retention
    • chest infection
    • other infection
    • paralytic ileus

  23. Serious adverse events

    Time frame: within 4 weeks after surgery

    • 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

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Collaborators

  • Korea Institute of Oriental Medicine
  • Korean Medicine Hospital of Pusan National University

Registry information

Official study title

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

Acronym: AcuPONV

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2015
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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