Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.

Not Applicable

• Conditions: Nausea, Postoperative; Pain, Postoperative; Pruritus; Vomiting, Postoperative
• Interventions: Drug: Bupivacaine Hydrochloride; Drug: Morphine Sulfate

• Registration Number: NCT04618146
• Lead Sponsor: Minia University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Study Start: 2020-11-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-26
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Bupivacaine Hydrochloride	given intrathecal bupivacaine 12.5 mg.
Group M50	Morphine Sulfate	given intrathecal bupivacaine 12.5mg + morphine 50 microgram.
Group M25	Morphine Sulfate	given intrathecal bupivacaine 12.5mg + morphine 25 microgram.
Group M25	Bupivacaine Hydrochloride	given intrathecal bupivacaine 12.5mg + morphine 25 microgram.
Group M50	Bupivacaine Hydrochloride	given intrathecal bupivacaine 12.5mg + morphine 50 microgram.

Primary Outcome Measures

Name	Time	Method
Pain postoperative	24 hours postoperatively	postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Minia university; 🇪🇬 Minya, Egypt