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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03427463
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Kathryn Harter Bridges, Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: receiving 0.1 mg IT morphine Drug: recieving 0.05 mg IT morphine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: Patients will be blinded
Primary Purpose: Treatment
Official Title: Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: receiving 0.1 mg IT morphine
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
Drug: receiving 0.1 mg IT morphine
Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

Experimental: recieving 0.05 mg IT morphine
Patients will receive 0.05 mg of intrathecal morphine
Drug: recieving 0.05 mg IT morphine
Patients will receive 0.05 mg of intrathecal morphine




Primary Outcome Measures :
  1. Time to first narcotic rescue dose in the first 24 hours posto cesarean delivery. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. time to first ambulation [ Time Frame: up to 48 hours ]
  2. opiate consumption [ Time Frame: 24 and 48 hours ]
  3. subjective pain rating using visual analogue scales (VAS) [ Time Frame: 24 hours post operatively ]
  4. presence of opiate side effects (nausea, vomiting, and pruritus) [ Time Frame: 24 hours post operavtively ]
  5. overall patient satisfaction with pain control [ Time Frame: 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Inclusion criteria consist of any parturient 18 years of age or older who is undergoing elective cesarean delivery under spinal anesthesia and is able to consent to the study and participate in the follow-up.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427463


Contacts
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Contact: Christie Aanstoos, MSN RN 843876-1869 aanstoos@musc.edu
Contact: Kathryn Bridges, MD 843 792 5699 bridgek@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Christie Aanstoos, MSN, RN    843-792-1869    aanstoos@musc.edu   
Principal Investigator: Kathryn Bridges, MD         
Sponsors and Collaborators
Medical University of South Carolina
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Responsible Party: Kathryn Harter Bridges, Medical Director, Anesthesia Preoperative Clinic Dept. of Anesthesia, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03427463    
Other Study ID Numbers: Pro00072393
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents