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Active, Not Recruiting

NCT Number: NCT04560712

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

acupuncture therapy

Procedure

Undergo acupuncture

Other names: Acupuncture

Best Practice

Other

Undergo usual care

Other names: standard of care, standard therapy

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Adherence rate to daily acupuncture

    Time frame: Up to 7 days

    Acupuncturist will document in the medical record all the treatments participants are completing and also document if missing any treatments.

  2. Compliance

    Time frame: Up to 7 days

    Acupuncturist and research coordinator will document in EPIC if participant is compliant with acupuncture sessions (study intervention) and with study questionnaires.

  3. Retention

    Time frame: Up to 7 days

    Will be measured as percentage of patients who complete the study out of the number of patients after study randomization.

Secondary outcomes

  1. Postoperative opioid use for pain management

    Time frame: 24 hours

    Will be compared between acupuncture and standard care groups. Will estimate the mean difference and 95% confidence interval (CI). Secondary analyses will be performed using analysis of covariance by adjusting for the postoperative opioid requirement for the first 24 hours (and/or other relevant patient characteristics).

  2. Pain levels

    Time frame: Up to 7 days

    Pain will be measured by the MD Anderson Symptom Inventory (MDASI) core symptoms to obatain data on satisfaction of pain control and other symptom mamgement starting on PDO1 and then every other day until discharge

  3. Satisfaction of pain control

    Time frame: Up to 7 days

    The satisfaction of pain control will be assessed using the MD Anderson Symptom Inventory (MDASI). The MDASI consists of a core list of symptoms that are common across all cancer diagnoses and treatments [15]. Participants will rate the intensity of physical, affective, and cognitive symptoms on a 0 to 10 numeric scale from "not present" to "as bad as you can imagine." Participants will also rate the amount of interference with daily activities caused by symptoms on a 0 to 10 numeric scale from "did not interfere" to "interfere completely"

Other outcomes

  1. Dietary recovery

    Time frame: Up to 7 days

    The dietary recovery will be obtained from the notes the dietitian documents in the medical record. Participants recovery is directly related to how fast they start eating a normal diet after surgery.

  2. Postoperative length of stay

    Time frame: Up to 7 days

    Will be compared between acupuncture and standard care groups. Will estimate the mean difference and 95% CI.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2020
Registry last updated
Jun 12, 2026

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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