Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally

Study Overview
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Brief Summary
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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

Official Title
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Multimodal Intrathecal Analgesia for Cesarean Section

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Morphine Sulfate
* Drug: Bupivacaine
* Drug: dexamethasone, morphine, midazolam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine<br>Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally. | Drug: Morphine Sulfate<br>* analgesia<br>* Other names: bupivacaine;Drug: Bupivacaine<br>* Analgesia<br>|
| Active Comparator: Multimodal<br>Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally | Drug: Bupivacaine<br>* Analgesia<br>Drug: dexamethasone, morphine, midazolam<br>* 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st analgesic requirement | The first time of supplemental analgesic need postoperatively | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption | Total analgesic consumption | 24 hours | 
| Post operative pain | Visual Analog Scale(0-10 with 0 is no pain and 10 is maximum intolerable pain) | 24 hours | 
| Side effects | 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. 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.) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrathecal morphine, midazolam, dexamethasone, cesarean section