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Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.

Primary Purpose

Pain, Postoperative, Pruritus, Nausea, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Morphine Sulfate
Bupivacaine Hydrochloride
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring pain, morphine, cesarean section, enhanced recovery

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Minia universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group C

Group M25

Group M50

Arm Description

given intrathecal bupivacaine 12.5 mg.

given intrathecal bupivacaine 12.5mg + morphine 25 microgram.

given intrathecal bupivacaine 12.5mg + morphine 50 microgram.

Outcomes

Primary Outcome Measures

Pain postoperative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain postoperative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain postoperative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2020
Last Updated
February 26, 2021
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04618146
Brief Title
Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.
Official Title
Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine. A Prospective Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pruritus, Nausea, Postoperative, Vomiting, Postoperative
Keywords
pain, morphine, cesarean section, enhanced recovery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
given intrathecal bupivacaine 12.5 mg.
Arm Title
Group M25
Arm Type
Active Comparator
Arm Description
given intrathecal bupivacaine 12.5mg + morphine 25 microgram.
Arm Title
Group M50
Arm Type
Active Comparator
Arm Description
given intrathecal bupivacaine 12.5mg + morphine 50 microgram.
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Other Intervention Name(s)
morphine
Intervention Description
intrathecal low dose morphine for early return to normal activity without opioid related complications.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
marcaine
Intervention Description
intrathecal bupivacaine 0.5%
Primary Outcome Measure Information:
Title
Pain postoperative
Description
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Time Frame
2 hours postoperatively
Title
Pain postoperative
Description
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Time Frame
4 hours postoperatively
Title
Pain postoperative
Description
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
vomiting
Description
four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting).
Time Frame
2 hours postoperative
Title
vomiting
Description
four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting).
Time Frame
4 hours postoperative
Title
vomiting
Description
four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting).
Time Frame
24 hours postoperative
Title
itching
Description
four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body).
Time Frame
2 hours postoperative
Title
itching
Description
four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body).
Time Frame
4 hours postoperative
Title
itching
Description
four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body).
Time Frame
24 hours postoperative
Title
respiratory depression
Description
respiratory rate less than 8 breaths \ minute
Time Frame
4 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females presenting for cesarean section
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohair A Megalla, MD
Phone
+20 120 003 6447
Email
Sohair.Adeeb@minia.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sohair A Megalla, MD
Organizational Affiliation
Anesthesia and ICU department, Faculty of Medicine, Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minia university
City
Minya
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohair A Megalla, MD
Phone
01200036447
Email
Sohair.Adeeb@minia.edu.eg

12. IPD Sharing Statement

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Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.

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