Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.

Study Overview
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Brief Summary
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This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay.

Detailed Description
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Parturients showing for elective cesarean section will be randomized into 3 groups by a computer generated randomization list. Each randomization slip will be put in a sealed envelope until patient enrollment. Patients will be divided into Group C: control group, given intrathecal bupivacaine 12.5 mg. Group M25: intrathecal bupivacaine 12.5mg + morphine 25 microgram. Group M50: intrathecal bupivacaine 12.5mg + morphine 50 microgram.

Official Title
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Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine. A Prospective Randomized Controlled Study.

Conditions
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Pain, Postoperative, Pruritus, Nausea, Postoperative, Vomiting, Postoperative

Intervention / Treatment
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* Drug: Morphine Sulfate
* Drug: Bupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females scheduled for cesarean section Age: 16-45 yrs. Gestation age >38 weeks. ASA I,II Exclusion Criteria: Refusal to participate. Significant cardiac, hepatic or renal dysfunction. History of chronic itching problem, or hyperemesis during pregnancy

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group C<br>given intrathecal bupivacaine 12.5 mg. | Drug: Bupivacaine Hydrochloride<br>* intrathecal bupivacaine 0.5%<br>* Other names: marcaine;|
| Active Comparator: Group M25<br>given intrathecal bupivacaine 12.5mg + morphine 25 microgram. | Drug: Morphine Sulfate<br>* intrathecal low dose morphine for early return to normal activity without opioid related complications.<br>* Other names: morphine;Drug: Bupivacaine Hydrochloride<br>* intrathecal bupivacaine 0.5%<br>* Other names: marcaine;|
| Active Comparator: Group M50<br>given intrathecal bupivacaine 12.5mg + morphine 50 microgram. | Drug: Morphine Sulfate<br>* intrathecal low dose morphine for early return to normal activity without opioid related complications.<br>* Other names: morphine;Drug: Bupivacaine Hydrochloride<br>* intrathecal bupivacaine 0.5%<br>* Other names: marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain postoperative | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 2 hours postoperatively | 
| Pain postoperative | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 4 hours postoperatively | 
| Pain postoperative | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vomiting | four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting). | 2 hours postoperative | 
| vomiting | four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting). | 4 hours postoperative | 
| vomiting | four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting). | 24 hours postoperative | 
| itching | four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body). | 2 hours postoperative | 
| itching | four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body). | 4 hours postoperative | 
| itching | four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body). | 24 hours postoperative | 
| respiratory depression | respiratory rate less than 8 breaths \ minute | 4 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, morphine, cesarean section, enhanced recovery