Resectable Pancreatic Carcinoma Clinical Trial
Official title:
Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations
Verified date | April 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
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 |
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