NCT07088432

Intravenous Dexamethasone for Prolonging Sensory Block in Spinal Anesthesia

Intravenous Dexamethasone for Prolonging the Sensory Block Duration of Spinal Anesthesia: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Tunis University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: Tunisia