Postoperative Pain
Conditions
Brief summary
The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery.
Detailed description
The study will be performed in Assiut University Hospitals, after obtaining approval from the local ethics committee and written informed patient consent. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5 inter-spinous space with 25G pencil-point spinal needle. All patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.
Interventions
DRUGMorphine
38 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.2 mg morphine (Infumorph - Injection 10 mg/mL) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
DRUGMorphine plus Nalbuphine
39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 mg morphine (Infumorph - Injection 10 mg/mL) plus 0.2 mg nalbuphine (NALUFIN 20MG/ML AMP) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
Sponsors
Abdelrady S Ibrahim, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Female patients * age between 16 to 40 years * ASA physical status I - II
Exclusion criteria
* Infection at the site of injection. * Coagulopathy or other bleeding diathesis. * Preexisting neurologic deficits. * History of hypersensitivity to any of the given the drugs. * Inability to communicate with the investigator and the hospital staff. * History of chronic opioid us
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 24 hours | Visual Analogue Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative itching | 24 hours | Visual Analogue Score |
| number of participants with incidence of postoperative nausea | 24 hours | Patients number |
| number of participants with incidence of postoperative vomiting | 24 hours | Patients number |
| number of participants with incidence of postoperative postdural puncture headache | 24 hours | Patients number |
| number of participants with incidence of postoperative respiratory depression | 24 hours | Patients number |
Countries
Egypt
Outcome results
None listed