Dexamethasone for Post Cesarean Delivery Analgesia

NCT01868633 | Completed Phase 4 Results DMC

• 1 other identifier: 201210765
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain. We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain

Conditions

Postoperative Pain

Keywords

Cesarean delivery; Analgesia; Pain; Dexamethasone; intrathecal morphine; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Analgesia

  Comparison of postoperative opioid analgesia use between the 2 groups

  24 hours

Secondary Outcomes (3)

• Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery

  24 hours

• Quality of Recovery

  48 hours

• Incidence and Severity of Nausea and Pruritus

  24 hours

Other Outcomes (1)

• Number of Participants With Chronic Pain After Cesarean Delivery

  6 months

Study Arms (2)

Dexamethasone & spinal morphine

ACTIVE COMPARATOR

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively

Drug: Dexamethasone

Placebo injection and spinal morphine

PLACEBO COMPARATOR

intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively

Drug: Placebo

Interventions

Dexamethasone DRUG

Also known as: Decadron

Dexamethasone & spinal morphine

Placebo DRUG

Also known as: Normal saline

Placebo injection and spinal morphine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English Speaking
• Non-laboring women
• Scheduled Elective Cesarean section under spinal anesthesia
• American Society of Anesthesiologists I-II physical status

You may not qualify if:

• Contraindications to spinal anesthesia
• allergy to study medication
• patients with allergy to morphine
• patients with uncontrolled hypertension
• history of peptic ulcer disease
• liver cirrhosis
• diabetes mellitus
• glaucoma
• known IV drug abusers
• patients with chronic pain or on long term opioids
• patients administered steroids in the past week
• women with fetuses having known congenital abnormalities
• psychiatric illness such that they are unable to comprehend or participate in study questions
• patients on antiviral medications or live virus vaccines would also be excluded.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Fujii Y, Nakayama M. Dexamethasone for reduction of nausea, vomiting and analgesic use after gynecological laparoscopic surgery. Int J Gynaecol Obstet. 2008 Jan;100(1):27-30. doi: 10.1016/j.ijgo.2007.07.017. Epub 2007 Sep 27.

  PMID: 17900579 BACKGROUND

• Murphy GS, Szokol JW, Greenberg SB, Avram MJ, Vender JS, Nisman M, Vaughn J. Preoperative dexamethasone enhances quality of recovery after laparoscopic cholecystectomy: effect on in-hospital and postdischarge recovery outcomes. Anesthesiology. 2011 Apr;114(4):882-90. doi: 10.1097/ALN.0b013e3181ec642e.

  PMID: 21297442 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Pain

Interventions

Dexamethasone; Calcium Dobesilate; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Unyime Ituk
• Organization: University of Iowa

unyime-ituk@uiowa.edu

3193562633

Study Officials

• Unyime Ituk, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 19, 2017
• Results First Posted: June 2, 2017

Record last verified: 2017-08

Locations

US (1)