Dexamethasone for Post-cesarean Delivery Pain

NCT01812057 | Completed Phase 4 Results

• 1 other identifier: Pro00041334
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare post-cesarean section consumption of pain medication between two groups of patients undergoing scheduled cesarean section at term gestation who receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo at 24 hours after surgery. The hypothesis is that a single perioperative dose of dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in women having cesarean delivery under spinal anesthesia.

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Keywords

Anesthesia; Cesarean Section; Pain, Postoperative; Postoperative Nausea and Vomiting; Dexamethasone; Injections, Spinal; morphine

Outcome Measures

Primary Outcomes (1)

• Morphine Consumption at 24 Hours Post-op

  The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine

  24 hours from admission to Postanesthesia care unit (PACU)

Secondary Outcomes (16)

• Pain Scores Between the Groups at 2 Hours.

  2 hours from admission to postanesthesia care unit (PACU)

• Time to Administration of First Rescue Analgesic Request Between the Groups.

  PACU admission to discharge from PACU an average of 2 hours

• Cumulative Opioid Consumption at 48 Hours Between the Groups

  Admission to PACU through 48 hours

• Pain Scores Between the Groups at 24 Hours.

  24 hours from PACU admission

• Pain Scores Between the Groups at 48 Hours.

  48 hours from PACU Admission

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Dexamethasone 8 mg IV given intraoperatively as a one-time dose.

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.

Drug: Placebo

Interventions

Dexamethasone DRUG

Dexamethasone 8 mg IV (as a one time dose)

Dexamethasone

Placebo DRUG

Sodium Chloride 0.9% -5 ml

Also known as: Sodium Chloride 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) class 1, 2 and 3
• Gestational age \> 37 weeks
• scheduled for elective cesarean delivery
• spinal or combined spinal epidural anesthesia
• years or older
• speak English

You may not qualify if:

• BMI \> 45 kg/m2
• Diabetes Mellitus (Type 1, 2 and gestational)
• mild or severe preeclampsia
• history of intravenous drug or opioid abuse
• previous history of chronic pain syndrome
• history of opioid use in the past week
• receipt of an antiemetic within 24 h prior to surgery
• Non-English speaking

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.

  PMID: 34002866 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The study was ended prior to completion of total planned enrollment of 104 subjects due to a change in clinical practice regarding post-operative pain medications that would have confounded the results of the study.

Results Point of Contact

• Title: Dr Terrence K Allen
• Organization: Duke University Medical Center

terrence.allen@duke.edu

9196682024

Study Officials

• Terrence Allen, MD

  Duke University

  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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 15, 2013
• Study Start: December 1, 2012
• Primary Completion: May 27, 2016
• Study Completion: September 21, 2016
• Last Updated: July 25, 2017
• Results First Posted: July 25, 2017

Record last verified: 2017-06

Locations

US (1)