A Phase 2 interventional study of Morphine Sulfate and Bupivacaine in Post Operative Pain, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-01-28.
Sponsored by Sohag University · Phase 2, Interventional, and Health services research
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
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Exclusion criteria:
Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.
Drug: Morphine Sulfate · Drug: Bupivacaine
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 · Drug: dexamethasone, morphine, midazolam
analgesia
Also known as: bupivacaine
Analgesia
Drug pages: Dexamethasone · Morphine · Midazolam
1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam
1st analgesic requirement
The first time of supplemental analgesic need postoperatively
Time frame: 24 hours
Analgesic consumption
Total analgesic consumption
Time frame: 24 hours
Post operative pain
Visual Analog Scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)
Time frame: 24 hours
Side effects
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.)
Time frame: 24 hours
Plan to share: No
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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Morphine · Dexamethasone · Midazolam