Pain, Postoperative
Conditions
Keywords
PCEA, PIEB, epidural analgesia
Brief summary
The aim of the study is to compare programmed intermittent bolus application and continuous epidural infusion with regard to additionally applied patient-controlled volume of local anesthesia and quality of analgesia.
Detailed description
Usually, patient controlled epidural analgesia (PCEA) is performed with a constant background infusion and patient-controlled bolus applications. An alternative approach is to give boluses at a regular rate for basic medication, instead of the continuous background infusion, maintaining the same amount of medication delivered per hour, (Programmed Intermittent Epidural Bolus injection; PIEB). In both cases, the patient has the option to trigger additional boluses. PIEB has been applied successfully in pain relief for lumbar epidural anesthesia in obstetrics, with better quality of analgesia and less total volume of local anesthetic required. It is assumed that the higher pressure in the epidural space with bolus injection results in a better and more uniform spread of the local anesthetic. In this study the PIEB-mode will be applied in major gynecological and abdominal surgery. In order to address the possibility that the different types of surgery result in different degrees of postoperative pain, the patients are stratified in three groups and randomized within these groups (Wertheim, Whipple, major colon surgery).
Interventions
PROCEDUREProgrammed intermittent epidural bolus application (PIEB)
Instead of a continuous background infusion of 6ml/h, one bolus injection is performed at the same amount per hour.
PROCEDUREContinous epidural analgesia
Sponsors
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Abdominal tumors in gynecology and general surgery * Enlightenment and written consent to the investigation
Exclusion criteria
* refusal to participate * pregnancy and breast feeding period * general contraindications for thoracic epidural anesthesia (e.g. coagulation disorders, --anticoagulation according to the guidelines of DGAI) * Impossibility to place the epidural catheter correctly * Known allergy to the drugs used in the study * Lack of understanding how to use the patient-controlled system * postoperative follow-up respiratory assistance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of additional patient-controlled bolus of ropivacaine 0.2% (consumption in ml) | Beginning of operation -6 pm on the second postoperative day | The patient-controlled bolus function is programmed with 4ml at a lock-out interval of 30min. The number of additional patient-controlled boli will be read off the epidural pump at 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of analgesia | At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day | Measured on a visual analog scale of 0-10 (0=no pain ; 10= worst imaginable pain |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with pain management | At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day | Measured on a visual analog scale of 0-10 |
| Necessity of additional rescue medication | Beginning of operation until 6 pm on the second postoperative day | Piritramid 7,5mg |
| motor blockade | Beginning of operation -6 pm on the second postoperative day | motor blockade is measured on the Bromage scale 0-3. |
| first defecation/flatus | after the operation till the end of hospital stay (max 20days) | dichotomous yes/no |
| Sensory blockade | Beginning of operation -6 pm on the second postoperative day | Sensory blockade is measured with a tiptherm, motor blockade on the Bromage scale 0-3 (0= no blockade; 1=Inability to lift legs stretched; 2=Inability to bend knees, 3=Inability to move feet ) |
Countries
Germany
Outcome results
None listed