Acupuncture for the Management of Postoperative Pain in Patients With Pancreatic or Colorectal Cancer Undergoing Surgery

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Resectable Pancreatic Carcinoma; Resectable Digestive System Carcinoma; Resectable Colorectal Carcinoma

Treatments: Other: Best Practice; Other: Questionnaire Administration; Procedure: Acupuncture Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04560712

2020-0234 (Other Identifier)

NCI-2020-05225 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Arm I (acupuncture, usual care)

Experimental group

Description:

Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes 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.

Treatment:

Procedure: Acupuncture Therapy

Other: Questionnaire Administration

Other: Best Practice

Arm II (usual care)

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Best Practice