C25
Conditions
Interventions
Group 1: Standard care group:
Receives standard pain management therapy according to the clinic SOP (standard operating procedure).
Group 2: Semipermanent acupuncture group:
Acupuncture group using S
Sponsors
Chirurgische Klinik der Universitätsklinik Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Pancreatoduodenectomy (PD) and distal pancreatectomy (DP), and total pancreatectomy (TP) for pancreatic malignant or benign disease • Perioperative pain management using an epidural catheter • Minimum age of 18 years • Sufficient communication skills
Exclusion criteria
Exclusion criteria: • Previous acupuncture experience for the same indication • Missing body parts for acupuncture (e.g. extremities) or infection or malignant tumor at the site of needle placement • Needle phobia • Relevant mental disorders (e.g. borderline patients with a risk of self-harm) • Serious coagulation disorders (e.g.: clinically relevant hemophilia) • intraoperative inoperability • neurological disorders (e.g. polyneuropathy, apoplexy) • chronic pain patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of pain intensity using a standardized pain scale (the Visual Analog Scale) at specific time intervals post-epidural catheter removal (e.g., 1 hours, 24 hours, 48 hours, 72 hours) or until dismission if earlier than 72h) in all groups: acupuncture vs. standard pain management according to the clinic SOP. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Use of Pain Medication: Quantification of pain medication usage (type and amount) following epidural catheter removal. b) Pain thresholds using pressure algometry before and after acupuncture treatment (PCE-PTR 200N). c) Gastrointestinal Function: Evaluation of gastrointestinal function, including time to first bowel movement and incidence of complications like constipation or ileus. d) Patient Mobility: Timed Up and Go (TUG) Test measures the time it takes for a person to stand up from a seated position, walk three meters, turn around, walk back, and sit down. e) Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) f) Duration of Hospital Stay: The length of hospital stay will be extracted from the patients charts. g) Lung Volume: The tidal volume will be assessed using a mobile spirometer immediately before and 1h, 24h, 48h and 72h after removal of epidural catheter. h) Quality of recovery (QoR-40): The quality of recovery after surgery will be measured by QoR-40 Score, which has been validated in multiple trials 7–10. The Score will be evaluated 72h after removal of epidural catheter. The total score as well as the subitems emotional state, physical comfort, patient support, physical independence and pain score will be evaluated as secondary endpoints. The Score will be assessed by interview using the QoR-40 questionnaire in German. The score consists of 5 dimensions (physical independence – 5 items, pain – 7 items, emotionalstate – 9 items, psychological support – 7 items, physical independence – 5 items). The total score is calculated by adding all items and ranges from 40 to 200, a score of 200 representing excellent recovery. i) Postoperative clinical events: Complications in the postoperative phase being possibly associated to acupuncture as defined below will be documented. These events include allergic reaction, acupuncture site infection, bleeding or hematoma, tissue damage around the acupuncture site (e.g. pneumothorax). In case of a | — |
Countries
Germany
Contacts
Public ContactCui Yang
Medical Faculty Mannheim University Heidelberg , Surgical department, University Medical Center Mannheim
Outcome results
None listed