Dexamethasone for Post-operative Pain After Cesarean Delivery Under Neuraxial Anesthesia.

NCT07257406 | Completed DMC

• 1 other identifier: 2019-1840
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

After surgery pain in women who have had a cesarean delivery is a determining factor in the quality and duration of their hospital stay. Insufficient pain relief can lead to longer hospitalization and long term pain, which can result in long term use of pain medication. A classic method to alleviate pain after cesarean delivery is by injecting morphine into the spinal fluid, in the women's back, in addition to prescribing morphine by mouth as needed after the surgery. However, the negative effects associated with morphine and morphine-like drugs, limit the doses used, their pain relief capacity, and can negatively affect the after surgical experience of women. An approach which uses pain relief that acts on different pain pathways to treat after surgery pain helps limit the negative effects of different drugs. The potential benefit of dexamethasone as pain relief in women who have had a cesarean delivery is all the more interesting because of its minimal negative effects compared to morphine-like drugs. Its low cost, its effectiveness to prevent nausea, and its impact on the general condition of patients make dexamethasone even more attractive.

Conditions

Pregnancy; Cesarean Delivery; Dexamethasone

Keywords

pregnancy; dexamethasone; cesarean; pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Score (VAS) 6 hours post-operatively at first rise

  Visual Analog Pain Score (VAS), from 0 to 10, when patients first stand out of bed 6 hours post-operatively. A score of 0 on 10 being no pain, and a score of 10 on 10 being the worst pain imaginable.

  6 hours post-operatively

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Drug: Dexamethasone (IV)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dexamethasone (IV) DRUG

Dexamethasone 8 mg IV will be given 5 minutes after cord clamping in the interventional arm.

Dexamethasone

Placebo DRUG

This arm will receive 2 ml of saline 5 min after cord clamping.

Placebo

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Cesarean delivery
• Planned spinal or combined neuraxial anesthesia
• Presence of an investigator in the delivery room
• Pregnancy \> 34 weeks gestation

You may not qualify if:

• Cesarean delivery under general anesthesia
• Inability to understand French or English
• Allergy or hypersensitivity to dexamethasone
• Allergy to hydromorphone
• Allergy to NSAIDs
• Acute kidney injury or chronic kidney failure
• Preeclampsia
• Extremely urgent cesarean section
• Urgent cesarean section with non-reassuring fetal monitoring
• Known maternal heart disease
• High-grade placental abnormality
• Diabetes (pregnancy or pre-existing)
• Systemic infection, sepsis, fever
• Regular use of dexamethasone in the last year
• Weight greater than 120 kg and less than 70 kg

Sponsors & Collaborators

• Valerie Zaphiratos: lead
• Université de Montréal: collaborator

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H2V 4K8, Canada

Location

Related Publications (3)

• Mohtadi A, Nesioonpour S, Salari A, Akhondzadeh R, Masood Rad B, Aslani SM. The effect of single-dose administration of dexamethasone on postoperative pain in patients undergoing laparoscopic cholecystectomy. Anesth Pain Med. 2014 Aug 13;4(3):e17872. doi: 10.5812/aapm.17872. eCollection 2014 Aug.

  PMID: 25237639 BACKGROUND

• Shahraki AD, Feizi A, Jabalameli M, Nouri S. The effect of intravenous Dexamethasone on post-cesarean section pain and vital signs: A double-blind randomized clinical trial. J Res Pharm Pract. 2013 Jul;2(3):99-104. doi: 10.4103/2279-042X.122370.

  PMID: 24991614 BACKGROUND

• Cardoso MM, Leite AO, Santos EA, Gozzani JL, Mathias LA. Effect of dexamethasone on prevention of postoperative nausea, vomiting and pain after caesarean section: a randomised, placebo-controlled, double-blind trial. Eur J Anaesthesiol. 2013 Mar;30(3):102-5. doi: 10.1097/EJA.0b013e328356676b.

  PMID: 23022704 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: September 13, 2018
• Primary Completion: June 8, 2021
• Study Completion: October 1, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)