Acupuncture for the Management of Postoperative Pain in Patients with Pancreatic or Colorectal Cancer Undergoing Surgery
Inclusion Criteria
- Undergoing open gastrointestinal cancer resection (pancreatic or colorectal)
- Must understand and read English
- Sign a written informed consent and willing to follow protocol requirements
- Able to consent to treatment
Exclusion Criteria
- Chronic opioid use > 90 mg MME (morphine milligram equivalents) for more than 7 days
- Mechanical bowel obstruction
- Active seizure activity after admission
- Compromised cognitive function per referring physician and/or inability to cooperate with acupuncture procedure
- Direct admission to intensive care unit after operation will result in removal from protocol
- Prior intra-abdominal operation in the past 6 months
- Any contraindications to acupuncture including infections or inability to access acupoint sites
Texas
Houston
PRIMARY OBJECTIVE:
I. Determine the feasibility of providing postoperative acupuncture for patients undergoing open colorectal or pancreatic surgery.
SECONDARY OBJECTIVE:
I. Compare postoperative opioid use for pain management, pain levels, and satisfaction of pain control between acupuncture and standard care groups.
EXPLORATORY OBJECTIVE:
I. Compare dietary recovery and postoperative length of stay between acupuncture and standard care groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ACUPUNCTURE): Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes once daily (QD) for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
ARM II (USUAL CARE): Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
Trial Phase Phase NA
Trial Type Supportive care
Lead Organization
M D Anderson Cancer Center
Principal Investigator
Wenli Liu
- Primary ID 2020-0234
- Secondary IDs NCI-2020-05225
- Clinicaltrials.gov ID NCT04560712