R52.0
Conditions
Interventions
Group 1: Patients who are treated with a TENS device postoperatively in addition to the standard pain medication. ("verum- TENS")
Group 2: Patients who are treated with a TENS device postoperatively
TAU-augmented)
Sponsors
Universitätsklinikum Hamburg-Eppendorf (UKE) ?Zentrum für Anästhesiologie und Intensivmedizin? Klinik und Poliklinik für Anästhesiologie ?Bereich Schmerzmedizin und Schmerzpsychologie?
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All patients older than 18 years of age and undergoing elective caesarean section are considered study participants.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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
| Measure | Time frame |
|---|---|
| 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. In addition, the daily consumption of analgesics, as well as nausea and vomiting is recorded postoperatively (rating sheet and station file). | — |
Countries
Germany
Contacts
Public ContactRegine Klinger
Bereich Schmerzmedizin und Schmerzpsychologie Universitätsklinikum Hamburg-Eppendorf (UKE) ?Zentrum für Anästhesiologie und Intensivmedizin ?Klinik und Poliklinik für Anästhesiologie
Outcome results
None listed