Pain
Conditions
Keywords
pain after cesarean, visual analog scale, oxycodon, piritramid
Brief summary
The purpose of this study is to investigate adequate pain treatment for patients after cesarean. In this study oral opioids were compared to intravenous opioids as they are supposed to provide superior pain control.
Detailed description
Pain management after cesarean is an important topic for women. Pain during and after surgery is their greatest concern. After surgery quick mobilization is important to take care of the newborn. When using a patient controlled analgesia (PCA) device mobilization is limited and women can not meet their expectations to take care of the newborn. Oral analgesia in comparison offers superior patient satisfaction. This trial was conducted to investigate the effectiveness of both treatment options and improve patients pain management and overall content after cesarean.
Interventions
DRUGOral Oxycodon
Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.
DRUGPiritramid
Patients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9% sodium chloride solution containing 60mg piritramide. Bolus injection of 0.5ml was administered by the patient herself if needed, with a lock out interval of 5 minutes Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. The PCA was discontinued after 24 hours or earlier if demanded.
Sponsors
University of Rostock
Max Dieterich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study participation was offered to all pts. aged \> 18 years in labor and delivery for elective or unplanned secondary cesarean in the 37th or higher week of gestation. Inclusion Criteria: * cesarean in spinal anesthesia, * no history of opioid or metamizol treatment * written consent * ability to use a Patient-controlled analgesia device
Exclusion criteria
* cesarean in general anaesthesia * use of peridural catheter for pre-, peri- or post cesarean analgesia * additional post cesarean metamizol use * allergy/hypersensitivity to morphine, oxycodon, acetaminophen or ibuprofen * chronic use of general anaesthesia * history of known pain syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of Pain Scores on the Visual Analog Scale | Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS. | The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline. For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain. Single value were calculated (averaged). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subgroups | 6 month | Secondary Outcome Measures were to identify subgroups in benefit of either therapy. |
| Side Effects | 6 month | Evaluation of side effects |
| Mobilisation | 6 month | Evaluation of time to post surgical mobilization |
| Costs | 6 month | Evaluation costs between groups |
Countries
Germany
Participant flow
Recruitment details
Recruitment between July 2009 and November 2009. Of 1112 patients 257 met the inclusion criteria and 239 agreed to participate
Participants by arm
| Arm | Count |
|---|---|
| Oxycodon Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS. | 113 |
| Patient Controlled Device With Pritramid Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose. | 126 |
| Total | 239 |
Baseline characteristics
| Characteristic | Total | Oxycodon | Patient Controlled Device With Pritramid |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 239 Participants | 113 Participants | 126 Participants |
| Age, Continuous | 29.2 years STANDARD_DEVIATION 5.5 | 28.5 years STANDARD_DEVIATION 5.9 | 29.8 years STANDARD_DEVIATION 5.1 |
| Gender Female | 239 Participants | 113 Participants | 126 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Germany | 239 participants | 113 participants | 126 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 113 | 0 / 126 |
| serious Total, serious adverse events | 0 / 113 | 0 / 126 |
Outcome results
Primary
Difference of Pain Scores on the Visual Analog Scale
The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline. For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain. Single value were calculated (averaged).
Time frame: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.
Population: The sample size (intention to treat) was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodon | Difference of Pain Scores on the Visual Analog Scale | 5.88 VAS score at 24 hours | Standard Deviation 2.01 |
| Patient Controlled Device With Pritramid | Difference of Pain Scores on the Visual Analog Scale | 4.85 VAS score at 24 hours | Standard Deviation 2.23 |
Comparison: The sample size of n=120 was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.~Because measurements were made several times on the same patients within in two independent groups, GLM Repeated Measurement procedure was applied to test null hypotheses about the effects of both the between-subject factor (study group) and the within-subject factor (time).p-value: <0.05Chi-squared
Secondary
Costs
Evaluation costs between groups
Time frame: 6 month
Secondary
Mobilisation
Evaluation of time to post surgical mobilization
Time frame: 6 month
Secondary
Side Effects
Evaluation of side effects
Time frame: 6 month
Secondary
Subgroups
Secondary Outcome Measures were to identify subgroups in benefit of either therapy.
Time frame: 6 month