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

Resectable Pancreatic Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04560712
• Other study ID #: 2020-0234
• Secondary ID: NCI-2020-0522520
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Neoplasms
• Pain, Postoperative
• Pancreatic Neoplasms
• Resectable Colorectal Carcinoma
• Resectable Digestive System Carcinoma
• Resectable Pancreatic Carcinoma

Intervention

Procedure:
• Acupuncture Therapy
Undergo acupuncture

Other:
• Best Practice
Undergo usual care
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary recovery	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.	Up to 7 days
Other	Postoperative length of stay	Will be compared between acupuncture and standard care groups. Will estimate the mean difference and 95% CI.	Up to 7 days
Primary	Adherence rate to daily acupuncture	Acupuncturist will document in the medical record all the treatments participants are completing and also document if missing any treatments.	Up to 7 days
Primary	Compliance	Acupuncturist and research coordinator will document in EPIC if participant is compliant with acupuncture sessions (study intervention) and with study questionnaires.	Up to 7 days
Primary	Retention	Will be measured as percentage of patients who complete the study out of the number of patients after study randomization.	Up to 7 days
Secondary	Postoperative opioid use for pain management	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).	24 hours
Secondary	Pain levels	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	Up to 7 days
Secondary	Satisfaction of pain control	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"	Up to 7 days

External Links

•   http://www.mdanderson.org