Post Caesarean Analgesia
Conditions
Keywords
analgesia, caesarean, wound infiltration, intrathecal morphine.
Brief summary
The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.
Detailed description
Double blind, 3 groups * Control group: Rachi 0,1 ml saline, Infusion 300ml saline * Group rachi-morphine: 0,1ml =100µg morphine/300ml saline * Group KT: 0,1 ml saline/300 ml naropin 0.2%
Interventions
wound infiltration
DRUGintrathecal morphine
100 µg added to the spinal anaesthesia
DRUGplacebo
placebo in spinal anaesthesia and in wound infiltration
Sponsors
Dr Madeleine Wilwerth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.
Exclusion criteria
* Refusal of the patient or contra-indication to locoregional anesthesia * Allergy to the products used * ASA 3 * ASA 4 * Sleep apnea syndrome and/or obesity (BMI \> 35) * Size inferior to 155cm * existence of a language barrier
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Effective Analgesia | 30 hours after spinal injection T0 | T0 until first request of morphine PCAIV |
| Morphine Consumption | 30 hours after spinal injection T0 | Morphine consumption with PCAIV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus. | 30 hours after spinal injection | Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus? |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine Infiltration ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
ropivacaine infiltration: wound infiltration | 63 |
| Rachi Morphine 100 µg intrathecal morphine and saline infiltration
intrathecal morphine: 100 µg added to the spinal anaesthesia | 61 |
| Placebo intrathecal saline and saline infiltration
placebo: placebo in spinal anaesthesia and in wound infiltration | 58 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 3 | 6 |
Baseline characteristics
| Characteristic | Ropivacaine Infiltration | Rachi Morphine | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 30 years | 32 years | 32 years | 32 years |
| Region of Enrollment Belgium | 63 participants | 61 participants | 58 participants | 182 participants |
| Sex: Female, Male Female | 63 Participants | 61 Participants | 58 Participants | 182 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 61 / 63 | 61 / 61 | 58 / 58 |
| serious Total, serious adverse events | 0 / 63 | 0 / 61 | 0 / 58 |
Outcome results
Primary
Duration of Effective Analgesia
T0 until first request of morphine PCAIV
Time frame: 30 hours after spinal injection T0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ropivacaine Infiltration | Duration of Effective Analgesia | 351 minutes |
| Rachi Morphine | Duration of Effective Analgesia | 380 minutes |
| Placebo | Duration of Effective Analgesia | 247 minutes |
Primary
Morphine Consumption
Morphine consumption with PCAIV
Time frame: 30 hours after spinal injection T0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ropivacaine Infiltration | Morphine Consumption | 8 milligrammes |
| Rachi Morphine | Morphine Consumption | 4 milligrammes |
| Placebo | Morphine Consumption | 20.5 milligrammes |
Secondary
Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?
Time frame: 30 hours after spinal injection