A randomized controlled trial to examine the effect of acupuncture strategies on pain relief and gastrointestinal recovery after bariatric surgery
Not Applicable
Recruiting
- Conditions
- Z98.0Intestinal bypass and anastomosis status
- Registration Number
- DRKS00029078
- Lead Sponsor
- niversitätsmedizin Mannheim Chirurgische Klinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Patients who undergo primary bariatric surgery for obesity
- Locus dolendi with maximum tenderness at points G1 to G6, VAS = 3 (rest pain or when moving) - Minimum age of 18 years
- Sufficient communication skills
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative pain before and after acupuncture evaluated via visual analogue scale
- Secondary Outcome Measures
Name Time Method - Use of morphine equivalents in the first 72 hours after acupuncture<br>- Pain thresholds using pressure algometry before and after acupuncture treatment (PCE-PTR 200N)<br>- Temperature of the abdominal skin using an infrared thermometer before and after the acupuncture<br>treatment<br>- Timing of first bowel movement<br>- Duration of hospital stay<br>- Tidal volume<br>- Quality of recovery (QoR-40)<br>- The length of time spent out of bed<br>- 6-minute walk test<br>- Amount of oral liquid consumption on postoperative day 1 (ml)<br>- 30 days postoperative clinical events<br>- Overall 30 days postoperative morbidity