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Completed

NCT Number: NCT07088432

Intravenous Dexamethasone for Prolonging Sensory Block in Spinal Anesthesia

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Habib Thameur Hospital

Tunis, Tunis Governorate, 1001, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Duration of sensory block

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

    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.

Secondary outcomes

  1. Duration of motor block

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

    The duration of the motor block was defined as the time from intrathecal injection until achieving a modified Bromage score of 3, which corresponds to partial motor recovery (able to move knees). The modified Bromage score was assessed every 15 minutes postoperatively. This measure was used to assess whether intravenous dexamethasone prolongs motor block following spinal anesthesia.

  2. Time to first analgesic request

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

    Time from intrathecal injection to the first request for postoperative analgesia, defined as the moment when the patient reported a pain score ≥ 3 on a visual analog scale (VAS, 0-10). This was recorded in minutes starting from the time of spinal anesthesia. The aim was to assess whether intravenous dexamethasone prolongs the duration of effective postoperative analgesia.

  3. Incidence of adverse events

    Time frame: From spinal injection until the end of surgery

    Adverse events occurring during the surgical procedure were systematically recorded. These included hypotension (systolic BP < 90 mmHg), bradycardia (HR < 50 bpm), nausea, vomiting, pruritus, and any signs of discomfort or neurological complications. All events were recorded as present or absent and compared between the dexamethasone and placebo groups to assess the safety profile of intravenous dexamethasone during spinal anesthesia.

  4. Surgeon satisfaction score

    Time frame: Immediately after the end of surgery

    Surgeon satisfaction with the quality of intraoperative anesthesia was assessed using a binary score (Satisfied / Not satisfied). The evaluation was based on intraoperative conditions such as patient immobility, comfort, and adequacy of anesthesia. The rating was collected at the end of surgery to compare the perceived quality between the dexamethasone and placebo groups.

Sponsors and collaborators

Lead sponsor

Tunis University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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