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

NCT ID: NCT05186454

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-23

Study Completion Date

2022-02-15

Brief Summary

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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

Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Morphine

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

Group Type ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type DRUG

analgesia

Bupivacaine

Intervention Type DRUG

Analgesia

Multimodal

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Analgesia

dexamethasone, morphine, midazolam

Intervention Type DRUG

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

Interventions

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Morphine Sulfate

analgesia

Intervention Type DRUG

Bupivacaine

Analgesia

Intervention Type DRUG

dexamethasone, morphine, midazolam

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

Intervention Type DRUG

Other Intervention Names

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bupivacaine

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Fouad Soliman

Lecturer of Anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fouad Soliman

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Fouad Soliman

Role: CONTACT

01113815186

Facility Contacts

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Fouad Soliman

Role: primary

01113815186

Other Identifiers

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2008

Identifier Type: -

Identifier Source: org_study_id

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