M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT04560712
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo acupuncture
Other names: Acupuncture
Undergo usual care
Other names: standard of care, standard therapy
Ancillary studies
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.
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.
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.
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).
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
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"
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.
Time frame: Up to 7 days
Will be compared between acupuncture and standard care groups. Will estimate the mean difference and 95% CI.
M.D. Anderson Cancer Center
Other
Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations
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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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