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

NCT05186454 | Unknown Phase 2 DMC

• 1 other identifier: 2008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain

Keywords

Intrathecal morphine, midazolam, dexamethasone, cesarean section

Outcome Measures

Primary Outcomes (1)

• 1st analgesic requirement

  The first time of supplemental analgesic need postoperatively

  24 hours

Secondary Outcomes (3)

• Analgesic consumption

  24 hours

• Post operative pain

  24 hours

• Side effects

  24 hours

Study Arms (2)

Morphine

ACTIVE COMPARATOR

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

Drug: Morphine Sulfate; Drug: Bupivacaine

Multimodal

ACTIVE COMPARATOR

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

Drug: Bupivacaine; Drug: dexamethasone, morphine, midazolam

Interventions

Morphine Sulfate DRUG

analgesia

Also known as: bupivacaine

Morphine

Bupivacaine DRUG

Analgesia

Morphine; Multimodal

dexamethasone, morphine, midazolam DRUG

1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam

Multimodal

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Fouad Soliman

Sohag, 52514, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; Bupivacaine; Dexamethasone; Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Central Study Contacts

Fouad Soliman

CONTACT

01113815186; fouad_soliman@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and ICU

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 11, 2022
• Study Start: May 23, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 15, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)