Unclassified lung pathologies and diseases for which a VATS is performed.
Conditions
Interventions
Group 1: Standard care group:
Receives standard pain therapy according to the hospital SOP.
Group 2: Acupuncture group:
Receives acupuncture therapy with classical needles, which are additionally elec
Sponsors
Chirurgische Klinik der Universitätsklinik Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients undergoing elective VATS - Sufficient communication skills
Exclusion criteria
Exclusion criteria: - 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, posttraumatic disorders, relevant depression) - Serious coagulation disorders (e.g.: clinically relevant hemophilia) - Neurological disorders (e.g. polyneuropathy, apoplexy) - Neurological devices (e.g. deep brain stimulation devices) - Cardiac assist devices (e.g. ICDs, CRT-Ds, pacemakers) - History of chronic pain - History of opioid or alcohol abuse - Previous thoracic surgery - Autoimmune disease affecting the skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this trial is the effectiveness of intraoperative acupuncture for pain reduction during VATS. Effectiveness will be assessed based on the following criteria: Pain reduction, retention rate (participants who complete the trial), acupuncture administration compliance, and patient and provider acceptability. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Assessment of pain intensity using a standardized pain scale (the Visual Analog Scale) in the postoperative period b) Intraoperative anaesthetics consumption c) Use of Pain Medication: Quantification of pain medication usage (type and amount) d) Time to spontaneous respiration, extubation time, eye-opening time, time to spontaneous movement, time to reorientation, and time to discharge from the operating room. e) Haemodynamic parameters intraoperative and in the postoperative setting: parameters measured during the intraoperative acupuncture intervention included the MAP, based on continuous arterial line monitoring, and HR. Included MAP variability (mean of MAP standard deviation, SD), BIS, and calculated Average Real Variability f) Pulmonary Function Tests g) Gastrointestinal Function: Evaluation of gastrointestinal function, including time to first bowel movement and incidence of complications like constipation or ileus. h) Postoperative Nausea and Vomiting (PONV) Syndromes, Apfel score. i) 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. j) Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) k) Duration of Hospital Stay: The length of hospital stay will be extracted from the patients charts. l) Incidence of opioid-related side effects (nausea, vomiting, constipation, respiratory depression). m) 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. The Score will be evaluated 72h after surgery. 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 – | — |
Countries
Germany
Contacts
Public ContactErfan Ghanad
Universitätsklinikum Mannheim
Outcome results
None listed