Electroacupuncture for Laparoscopic/ Robotic Colorectal Surgery

NCT02773472 | Terminated DMC

• 1 other identifier: UW15-214
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

A multimodal approach for management of post-operative pain is used to improve analgesia, minimize side effects, and improve recovery. Nevertheless, opioid analgesics and intravenous patient controlled analgesia remains the mainstay of postoperative analgesia after colorectal surgery. Opioids are associated with various side effects such as nausea, vomiting, sedation, dizziness, respiratory depression, urinary retention and reduced bowel movement. These side effects are unpleasant and lead to prolonged recovery. Use of non-pharmacological analgesic techniques may improve postoperative pain control and reduce opioid consumption. Acupuncture has been used for over 3000 years in China for treatment of pain and various other conditions. Acupuncture and related techniques are simple and safe. There is evidence that acupuncture can reduce postoperative pain intensity, opioid consumption, and opioid related side effects.

Conditions

Acute Pain

Keywords

colorectal; electroacupuncture; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Acute pain

  Severity of postoperative pain will be assessed using numerical rating scale

  at postoperative day 3

Secondary Outcomes (1)

• Chronic pain

  at postoperative 3 months

Study Arms (2)

Electroacupuncture Group

EXPERIMENTAL

In addition to morphine, patients will receive 4 sessions of electroacupuncture after surgery over four days, with each session lasting 30 minutes.

Device: electroacupuncture

Morphine Group

OTHER

Neither electroacupuncture nor sham acupuncture will be given. Patient use morphine for analgesia.

Drug: morphine

Interventions

electroacupuncture DEVICE

The acupoints that will be stimulated are: daheng, tianshu, zhongwan, xiawan, qihai, guanuian, hegu, guchi, zusanli, sanyinjiao, gongsun. An alternating fast-slow frequency of 20Hz/6Hz will be used with an interval of 250msec. The intensity (mA) will be adjusted to a level tolerated by each individual patient.

Electroacupuncture Group

morphine DRUG

Patient will not receive electroacupuncture. Patient will use morphine for analgesia.

Morphine Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The American Society of Anesthesiologists adopted physical status classification system (ASA) I to III
• Age 18 to 80 years old
• Scheduled for elective laparoscopic/ robotic colonic or upper rectal resection in Queen Mary hospital.

You may not qualify if:

• Open colorectal surgery
• Extended resection involving other organs such as liver and urinary bladder
• Known drug allergy to alpha-2 agonists, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors, paracetamol, or sulphonamides
• Alcohol or drug abuse
• Known history of pulmonary embolism or deep vein thrombosis
• Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
• Impaired hepatic function, defined as preoperative serum albumin level less than 30g/L
• Impaired or retarded mental state
• Not self-ambulatory before operation
• Difficulties in using patient-controlled analgesia
• Body Mass Index \> 35kg/m2
• Pregnancy
• Local infection
• Abdominal wound
• Patient refusal

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Electroacupuncture; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Stanley SC Wong, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: May 16, 2016
• Study Start: August 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: March 24, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)