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Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Morphine Sulfate
Bupivacaine
dexamethasone, morphine, midazolam
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post Operative Pain focused on measuring Intrathecal morphine, midazolam, dexamethasone, cesarean section

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • ASA I-II
  • Age 20-40 years.
  • Pregnant women with living fetus.
  • Body mass index 20- 35 kg/m2.

Exclusion criteria:

  • Patient refusal.
  • Age < 20 or > 40 years
  • Body mass index < 20 or > 35.
  • Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia).
  • Placental abnormalities: placental abruption, placenta previa or accrete.
  • Allergy to drugs used in the study.

Sites / Locations

  • Fouad SolimanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Morphine

Multimodal

Arm Description

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.

Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally

Outcomes

Primary Outcome Measures

1st analgesic requirement
The first time of supplemental analgesic need postoperatively

Secondary Outcome Measures

Analgesic consumption
Total analgesic consumption
Post operative pain
Visual Analog Scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)
Side effects
Pruritus (assessed the number of patients suffering from pruritus and grading the degree as follow:Mild= Itching is a minor concern, Moderate = Itching is a primary concern, but bearable,Severe= Unbearable; patient need anti-histaminic treatment. Nausea and/or vomiting(assessed on 4 grade scales: 0= no symptoms present, 1 =mild nausea with no need for pharmacological treatment, 2= moderate nausea that required treatment (ondansetron 4 mg), 3= severe nausea that is resistant to treatment). 3-Sedation (assessed on 4 grade scale: 1-awake and alert, 2 -slightly drowsy, easily aroused, 3 -drowsy, drifts off to sleep during conversation, 4 -somnolent, minimal, or no response to physical stimulation). 4- Respiratory depression whether present or not(Respiratory depression was defined as a respiratory rate ≤10/min.)

Full Information

First Posted
December 26, 2021
Last Updated
January 26, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05186454
Brief Title
Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally
Official Title
Multimodal Intrathecal Analgesia for Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Anticipated)
Study Completion Date
February 15, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam. Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Intrathecal morphine, midazolam, dexamethasone, cesarean section

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 200 µg of morphine intrathecally.
Arm Title
Multimodal
Arm Type
Active Comparator
Arm Description
Patients will receive 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam intrathecally
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Other Intervention Name(s)
bupivacaine
Intervention Description
analgesia
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Analgesia
Intervention Type
Drug
Intervention Name(s)
dexamethasone, morphine, midazolam
Intervention Description
1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam
Primary Outcome Measure Information:
Title
1st analgesic requirement
Description
The first time of supplemental analgesic need postoperatively
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Analgesic consumption
Description
Total analgesic consumption
Time Frame
24 hours
Title
Post operative pain
Description
Visual Analog Scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)
Time Frame
24 hours
Title
Side effects
Description
Pruritus (assessed the number of patients suffering from pruritus and grading the degree as follow:Mild= Itching is a minor concern, Moderate = Itching is a primary concern, but bearable,Severe= Unbearable; patient need anti-histaminic treatment. Nausea and/or vomiting(assessed on 4 grade scales: 0= no symptoms present, 1 =mild nausea with no need for pharmacological treatment, 2= moderate nausea that required treatment (ondansetron 4 mg), 3= severe nausea that is resistant to treatment). 3-Sedation (assessed on 4 grade scale: 1-awake and alert, 2 -slightly drowsy, easily aroused, 3 -drowsy, drifts off to sleep during conversation, 4 -somnolent, minimal, or no response to physical stimulation). 4- Respiratory depression whether present or not(Respiratory depression was defined as a respiratory rate ≤10/min.)
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: ASA I-II Age 20-40 years. Pregnant women with living fetus. Body mass index 20- 35 kg/m2. Exclusion criteria: Patient refusal. Age < 20 or > 40 years Body mass index < 20 or > 35. Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia). Placental abnormalities: placental abruption, placenta previa or accrete. Allergy to drugs used in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fouad Soliman
Phone
01113815186
Email
fouad_soliman@med.sohag.edu.eg
Facility Information:
Facility Name
Fouad Soliman
City
Sohag
ZIP/Postal Code
52514
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fouad Soliman
Phone
01113815186
Email
fouad_soliman@med.sohag.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally

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