Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.

Minia University

Status: Unknown

Conditions: Vomiting, Postoperative; Pain, Postoperative; Nausea, Postoperative; Pruritus

Treatments: Drug: Bupivacaine Hydrochloride; Drug: Morphine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04618146

680-9\2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Group C

Placebo Comparator group

Description:

given intrathecal bupivacaine 12.5 mg.

Treatment:

Drug: Bupivacaine Hydrochloride

Group M25

Active Comparator group

Description:

given intrathecal bupivacaine 12.5mg + morphine 25 microgram.

Treatment:

Drug: Morphine Sulfate

Drug: Bupivacaine Hydrochloride

Group M50

Active Comparator group

Description:

given intrathecal bupivacaine 12.5mg + morphine 50 microgram.

Treatment:

Drug: Morphine Sulfate

Drug: Bupivacaine Hydrochloride