Intravenous Dexamethasone for Prolonging Sensory Block in Spinal Anesthesia

NCT ID: NCT07088432

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intravenous Dexamethasone Group

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.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: 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 Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tunis University

OTHER

Sponsor Role: lead

Responsible Party

Kamel ben Fadhel

Professor, Department of Anesthesiology and Intensive Care, Habib Thameur Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samia Arfaoui, Medical Doctor

Role: STUDY_DIRECTOR

Habib Thameur Hospital

Kamel Ben Fadhel, Medical Doctor

Role: STUDY_CHAIR

Habib Thameur Hospital

Locations

Habib Thameur Hospital

Tunis, Tunis Governorate, Tunisia

Countries

Tunisia

Other Identifiers

HTHEC-2023-26

Identifier Type: -

Identifier Source: org_study_id