Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Compliance
Study Overview
Brief 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.
Detailed 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm I (acupuncture, usual care)
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.
Intervention: Acupuncture Therapy (Procedure)
Arm I (acupuncture, usual care)
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.
Intervention: Best Practice (Other)
Arm I (acupuncture, usual care)
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.
Intervention: Questionnaire Administration (Other)
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.
Intervention: Questionnaire Administration (Other)
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.
Intervention: Best Practice (Other)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Satisfaction of pain control(Up to 7 days)
- Pain levels(Up to 7 days)
- Postoperative opioid use for pain management(24 hours)