Intravenous Dexamethasone for Prolonging Sensory Block in Spinal Anesthesia

NCT07088432 | Completed

• 1 other identifier: HTHEC-2023-26
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Duration of sensory block

  The duration of the sensory block was defined as the time from intrathecal injection of the local anesthetic until regression of sensory level to the L1 dermatome, as assessed by pinprick test every 15 minutes postoperatively. This endpoint was selected to evaluate the effect of intravenous dexamethasone on prolonging the duration of spinal anesthesia.

  From the time of spinal injection until sensory regression to L1 dermatome (up to 4 hours postoperatively)

Secondary Outcomes (4)

• Duration of motor block

  From the time of spinal injection until modified Bromage score = 3 (up to 4 hours postoperatively)

• Time to first analgesic request

  From spinal injection until VAS score ≥ 3 and first analgesic request (up to 6 hours postoperatively)

• Incidence of adverse events

  From spinal injection until the end of surgery

• Surgeon satisfaction score

  Immediately after the end of surgery

Study Arms (2)

Intravenous Dexamethasone Group

EXPERIMENTAL

Participants in this arm received 8 mg of intravenous dexamethasone (2 mL) 5 minutes before spinal anesthesia. The spinal anesthesia was performed with 12.5 mg of 0.5% hyperbaric bupivacaine combined with 2.5 µg of sufentanil. The purpose was to evaluate whether intravenous dexamethasone prolongs the duration of sensory and motor block and improves postoperative analgesia.

Drug: Dexamethasone

Placebo Group

PLACEBO COMPARATOR

Participants in this arm received 2 mL of isotonic saline intravenously 5 minutes before spinal anesthesia. The spinal anesthesia was performed identically to the intervention group (12.5 mg of hyperbaric bupivacaine + 2.5 µg sufentanil). This arm served as the control group for evaluating the effects of dexamethasone.

Drug: Placebo

Interventions

Dexamethasone DRUG

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.

Intravenous Dexamethasone Group

Placebo DRUG

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 to 80 years
• ASA physical status I or II
• Scheduled for elective pelvic surgery under spinal anesthesia (urologic, inguinal, or proctologic procedures)
• Provided informed consent

You may not qualify if:

• Known allergy to dexamethasone or local anaesthetics
• Contraindications to spinal anesthesia
• Neurological diseases
• Chronic use of corticosteroids or immunosuppressants
• BMI \> 40 kg/m²
• Refusal to participate

Sponsors & Collaborators

• Tunis University: lead

Study Sites (1)

Habib Thameur Hospital

Tunis, Tunis Governorate, 1001, Tunisia

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Samia Arfaoui, Medical Doctor

  Habib Thameur Hospital

  STUDY DIRECTOR

• Kamel Ben Fadhel, Medical Doctor

  Habib Thameur Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patient, anesthesia provider, surgeon, and outcome assessor were all blinded to group allocation. The syringes were prepared by a resident not involved in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology and Intensive Care, Habib Thameur Hospital

Model Details: Two-arm, parallel, randomized controlled trial with 1:1 allocation

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: October 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

TU (1)