Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Pruritus; Nausea, Postoperative; Vomiting, Postoperative
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Drug: Morphine Sulfate

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Recruiting
    • Minia University
    • Contact: Sohair A Megalla, MD; Phone Number: 01200036447; Email: Sohair.Adeeb@minia.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Group C; given intrathecal bupivacaine 12.5 mg.	Drug: Bupivacaine Hydrochloride; intrathecal bupivacaine 0.5%; Other Names: marcaine
ACTIVE_COMPARATOR: Group M25; given intrathecal bupivacaine 12.5mg + morphine 25 microgram.	Drug: Bupivacaine Hydrochloride; intrathecal bupivacaine 0.5%; Other Names: marcaine; Drug: Morphine Sulfate; intrathecal low dose morphine for early return to normal activity without opioid related complications.; Other Names: morphine
ACTIVE_COMPARATOR: Group M50; given intrathecal bupivacaine 12.5mg + morphine 50 microgram.	Drug: Bupivacaine Hydrochloride; intrathecal bupivacaine 0.5%; Other Names: marcaine; Drug: Morphine Sulfate; intrathecal low dose morphine for early return to normal activity without opioid related complications.; Other Names: morphine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Sohair A Megalla, MD, Anesthesia and ICU department, Faculty of Medicine, Minia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pain; cesarean section; morphine; enhanced recovery
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Skin Manifestations; Nausea; Pain, Postoperative; Vomiting; Pruritus; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: 680-9\2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No