Intravenous Dexamethasone for Prolonging Sensory Block in Spinal Anesthesia

Tunis University

Status: Completed

Conditions: Proctologic Surgery; Pelvic Surgery; Spinal Anesthesia; Postoperative Pain Management; Urologic Surgery; Dexamethasone

Treatments: Drug: Placebo; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07088432

HTHEC-2023-26

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Intravenous Dexamethasone Group

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo