Intravenous Dexamethasone Effectiveness in Post Caesarean Section Analgesia

NCT05535036 | Completed

• 1 other identifier: dexa C section
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The management of postpartum pain is essential to ensure early rehabilitation for parturients. Intravenous dexamethasone has a potent analgesic action when used in the context of general anesthesia. Nevertheless, it remains poorly studied in combination with spinal anesthesia (SA). The aim of this study was to assess the analgesic effect of intravenous dexamethasone after caesarean section under SA. Methods: We conducted a prospective, randomized, double-blinded study including 84 ASA II-III parturient at term who were proposed for caesarean section under SA. Parturient were randomized into two groups: Dexamethasone group (DG) who received 8mg of intravenous dexamethasone (2ml) immediately after SA and placebo group (PG) who received 2ml of isotonic saline. The analgesic protocol was standardized and we opted for Tramadol as rescue analgesic. The main outcome is the use of Tramadol in the first 24 hours postpartum..

Conditions

Cesarean Section; Dexamethasone; Postoperative Pain; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• tramadol requirements

  The rescue analgesic was IV Tramadol 100 mg administered at the request of the patient and if the analog visual scale (AVS) was greater than 3/10, with a maximum dose of 100 mg \* 3/day.

  24 hours

Secondary Outcomes (3)

• pain scores

  H2, H6, H12 and H24

• postoperative nausea and vomiting(PONV)

  24 hours

• Chronic pain

  3 months

Study Arms (2)

dexamethasone group

EXPERIMENTAL

patients received 8mg(2ml) of intravenous dexamethasone after spinal anesthesia

Drug: Dexamethasone 4mg

placebo group

PLACEBO COMPARATOR

patients received 2ml of a saline solution after spinal anesthesia

Drug: Placebo

Interventions

Dexamethasone 4mg DRUG

all patients had standard non-invasive monitoring including an electrocardiogram, non invasive blood pressure and pulse oxymetry. An 18-gauge intravenous cannula was inserted into the nondominant arm or hand and 500 ml of a saline solution (0.9 %) was infused. The prevention of postoperative nausea and vomiting (PONV) was assured to all patients by administering 4 mg of IV Ondansetron. Spinal anesthesia was performed according to our department protocol: L4-L5 or L3-L4 intervertebral space puncture using a 25 gauges needle, with injection of 0.5% hyperbaric Bupivacaine mixture (dose depending on patient height) associated with 2.5 ug Sufentanil and 100 ug Morphine. Before surgical incision, patients received either an intravenous injection of 8 mg (2 ml) Dexamethasone (DG) or 2 ml of a Saline solution (PG).

dexamethasone group

Placebo DRUG

patients received 2ml of intravenous saline solution

placebo group

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 Anesthesiologists (ASA) statue II-III,
• a pregnancy term \>= 37 weeks
• elective cesarean section
• Pfannenstiel incision

You may not qualify if:

• severe hypertension / preeclampsia
• poorly balanced diabetes mellitus
• allergy to one of the study drugs
• patients with chronic pain or long-term use of opioids
• patients on long-term corticosteroid therapy.

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (1)

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical Professor

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 10, 2022
• Study Start: February 10, 2020
• Primary Completion: September 30, 2020
• Study Completion: January 4, 2021
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)