Post Operative Pain
Conditions
Keywords
Intrathecal morphine, midazolam, dexamethasone, cesarean section
Brief summary
Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam. Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine
Interventions
DRUGMorphine Sulfate
analgesia
DRUGBupivacaine
Analgesia
DRUGdexamethasone, morphine, midazolam
1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* ASA I-II * Age 20-40 years. * Pregnant women with living fetus. * Body mass index 20- 35 kg/m2.
Exclusion criteria
* Patient refusal. * Age \< 20 or \> 40 years * Body mass index \< 20 or \> 35. * Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia). * Placental abnormalities: placental abruption, placenta previa or accrete. * Allergy to drugs used in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1st analgesic requirement | 24 hours | The first time of supplemental analgesic need postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic consumption | 24 hours | Total analgesic consumption |
| Post operative pain | 24 hours | Visual Analog Scale(0-10 with 0 is no pain and 10 is maximum intolerable pain) |
| Side effects | 24 hours | 1. Pruritus (assessed the number of patients suffering from pruritus and grading the degree as follow:Mild= Itching is a minor concern, Moderate = Itching is a primary concern, but bearable,Severe= Unbearable; patient need anti-histaminic treatment. 2. Nausea and/or vomiting(assessed on 4 grade scales: 0= no symptoms present, 1 =mild nausea with no need for pharmacological treatment, 2= moderate nausea that required treatment (ondansetron 4 mg), 3= severe nausea that is resistant to treatment). 3-Sedation (assessed on 4 grade scale: 1-awake and alert, 2 -slightly drowsy, easily aroused, 3 -drowsy, drifts off to sleep during conversation, 4 -somnolent, minimal, or no response to physical stimulation). 4- Respiratory depression whether present or not(Respiratory depression was defined as a respiratory rate ≤10/min.) |
Countries
Egypt
Contacts
Primary ContactFouad Soliman
Outcome results
None listed