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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04618146
Other study ID # 680-9\2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 10, 2020
Est. completion date March 2021

Study information

Verified date February 2021
Source Minia University
Contact Sohair A Megalla, MD
Phone +20 120 003 6447
Email Sohair.Adeeb@minia.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 45 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Morphine Sulfate
intrathecal low dose morphine for early return to normal activity without opioid related complications.
Bupivacaine Hydrochloride
intrathecal bupivacaine 0.5%

Locations

Country Name City State
Egypt Minia university Minya

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain postoperative postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain 2 hours postoperatively
Primary Pain postoperative postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain 4 hours postoperatively
Primary Pain postoperative postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain 24 hours postoperatively
Secondary vomiting four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting). 2 hours postoperative
Secondary vomiting four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting). 4 hours postoperative
Secondary vomiting four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting). 24 hours postoperative
Secondary itching four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body). 2 hours postoperative
Secondary itching four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body). 4 hours postoperative
Secondary itching four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body). 24 hours postoperative
Secondary respiratory depression respiratory rate less than 8 breaths \ minute 4 hours postoperative
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