Clinical trial NCT04560712: Acupuncture for the Management of Postoperative Pain in Patients With Pancreatic or Colorectal Cancer Undergoing Surgery
Official title: Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Resectable Colorectal Carcinoma
Resectable Digestive System Carcinoma
Resectable Pancreatic Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial investigates how well acupuncture works for the management of pain after surgery in patients having open colorectal or pancreatic surgery. Acupuncture may help to reduce postoperative symptoms including pain. This study may help researchers learn if acupuncture reduces after-surgery side effects and improves recovery.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence rate to daily acupuncture
timeFrame: Up to 7 days
measure: Compliance
timeFrame: Up to 7 days
measure: Retention
timeFrame: Up to 7 days
Secondary outcomes:
measure: Postoperative opioid use for pain management
timeFrame: 24 hours
measure: Pain levels
timeFrame: Up to 7 days
measure: Satisfaction of pain control
timeFrame: Up to 7 days
Other outcomes:
measure: Dietary recovery
timeFrame: Up to 7 days
measure: Postoperative length of stay
timeFrame: Up to 7 days
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen
role: PRINCIPAL_INVESTIGATOR
References: