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Comparison of 0.1 and 0.05mg Intrathecal Morphine for Post-cesarean Analgesia.

NCT ID: NCT03427463

Last Updated: 2024-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2023-08-03

Brief Summary

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The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.

Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be conducted as a randomized controlled single-blinded clinical trial with patients being randomized to receive either 0.1 or 0.05 mg of IT morphine.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients will be blinded

Study Groups

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receiving 0.1 mg IT morphine

Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

Group Type ACTIVE_COMPARATOR

receiving 0.1 mg IT morphine

Intervention Type DRUG

Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

recieving 0.05 mg IT morphine

Patients will receive 0.05 mg of intrathecal morphine

Group Type EXPERIMENTAL

recieving 0.05 mg IT morphine

Intervention Type DRUG

Patients will receive 0.05 mg of intrathecal morphine

Interventions

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receiving 0.1 mg IT morphine

Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

Intervention Type DRUG

recieving 0.05 mg IT morphine

Patients will receive 0.05 mg of intrathecal morphine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* any parturient 18 years of age or older
* undergoing elective cesarean delivery under spinal anesthesia
* able to consent to the study and participate in the follow-up.

Exclusion Criteria

* any known allergy to morphine
* general anesthesia
* urgent or emergent cases
* any bleeding diathesis or other coagulopathy
* known G6PD deficiency
* any known liver disease
* known alcohol abuse or dependence
* HELLP syndrome
* thrombocytopenia or known platelet dysfunction
* history or active gastrointestinal bleeding
* acute kidney injury or chronic renal insufficiency
* contraindication/refusal to spinal anesthestic
* chronic pain
* chronic narcotic use
* illicit drug use
* allergy to any study related medications
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Katherine Hatter, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00072393

Identifier Type: -

Identifier Source: org_study_id