Extent of analgesic effects of transcutaneous electrical nerve stimulation in patients after caesarean sectio
- Conditions
- R52.0Acute pain
- Registration Number
- DRKS00013123
- Lead Sponsor
- niversitätsklinikum Hamburg-Eppendorf (UKE) ?Zentrum für Anästhesiologie und Intensivmedizin? Klinik und Poliklinik für Anästhesiologie ?Bereich Schmerzmedizin und Schmerzpsychologie?
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 162
All patients older than 18 years of age and undergoing elective caesarean section are considered study participants.
Excluded are patients under the age of 18 years. At the time of intervention the patients are no longer pregnant. Patients who need emergency surgery and / or intensive care monitoring are also excluded. If complications occur intraoperatively (e.g., delivery of a sick newborn, hemorrhagic shock, etc.) and / or during hospitalization (e.g., embolism with ICU stay), the patients are also excluded from the study. Patients who can not explain or explain their consent (for example, incompliance or dementia) or who indicate in the preoperative examination to suffer from a psychiatric illnesses and / or chronic pain are also excluded from the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of this study is the experienced postoperative pain intensity (related to the caesarean section surgical wound), which is measured using an 11-point numerical rating scale (0-10: 0 = none, 10 = most severe pain imaginable).<br>The presence of any other pain is assessed preoperatively (during premedication). Postoperatively, the patients receive a pain diary. Pain intensity is assessed every 2 hours. The pain diary data are collected until discharge (about 3-4 days after surgery). 3 and 6 months after discharge, a single pain intensity value is requested by questionnaire.
- Secondary Outcome Measures
Name Time Method Psychological variables are also to be assessed as secondary endpoints: subjective mood (general depression scale), catastrophizing (questionnaire for pain treatment in pain situations), functional capacity (pain and mood inventory including postoperative functional capacity). These data are collected preoperatively (premedication interview) and postoperatively (surgery day, day 1 after surgery and discharge day, and 3 and 6 months after discharge). Also, preoperative (premedication interview) and postoperative (daily) expectation regarding pain treatment (TENS and / or medication) is assessed.<br>In addition, the daily consumption of analgesics, as well as nausea and vomiting is recorded postoperatively (rating sheet and station file).<br>