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Intravenous Dexamethasone for Prolonging Sensory Block in Spinal Anesthesia

NCT07088432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-28

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if intravenous dexamethasone can help prolong the effect of spinal anesthesia in adults having elective pelvic, urologic, or proctologic surgery. The study also looks at whether dexamethasone improves pain control after surgery and whether it causes any side effects.

The main questions it aims to answer are:

Does intravenous dexamethasone increase how long the spinal anesthesia lasts?

Does it reduce the need for pain medications after surgery?

Does it cause more or fewer side effects compared to a placebo?

In this study:

Participants were randomly assigned to receive either 8 mg of intravenous dexamethasone or a placebo (salt water).

All participants received standard spinal anesthesia with bupivacaine and sufentanil.

Researchers measured how long the spinal anesthesia lasted and when the first pain medication was needed after surgery.

Participants were monitored for side effects such as low blood pressure, nausea, vomiting, and slow heart rate.

Surgeon satisfaction with anesthesia quality was also recorded.

Participants did not receive any additional procedures beyond routine care. The study found that dexamethasone helped prolong the spinal anesthesia and delayed the need for pain relief, without increasing side effects.

Conditions

  • Spinal Anesthesia
  • Postoperative Pain Management
  • Dexamethasone
  • Pelvic Surgery
  • Urologic Surgery
  • Proctologic Surgery

Interventions

DRUG

Dexamethasone

Single intravenous injection of 8 mg dexamethasone (2 mL) administered 5 minutes before spinal anesthesia. This intervention was tested for its effect on prolonging the duration of sensory and motor blocks induced by hyperbaric bupivacaine combined with sufentanil. The drug was administered under sterile conditions by an anesthesiologist blinded to group allocation.

DRUG

Placebo

Single intravenous injection of 2 mL isotonic saline (0.9% NaCl) administered 5 minutes before spinal anesthesia. This placebo was used to mimic the dexamethasone injection in the control group. The preparation, volume, and timing were identical to the intervention group to maintain blinding. The saline was administered under sterile conditions by an anesthesiologist blinded to group allocation.

Sponsors & Collaborators

  • Tunis University

    lead OTHER

Principal Investigators

  • Samia Arfaoui, Medical Doctor · Habib Thameur Hospital

  • Kamel Ben Fadhel, Medical Doctor · Habib Thameur Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07088432 on ClinicalTrials.gov