Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04618146
• Other study ID #: 680-9\2020
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Nausea, Postoperative
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Pruritus
• Vomiting
• Vomiting, Postoperative

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