Comparing Low and Intermediate Doses of Dexamethasone for Rebound Pain After Foot Surgery in Patients Receiving Nerve Block Anesthesia

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What is this study about?

This study examines pain that occurs after foot surgery, specifically focusing on two types of pain: postoperative pain and a type of pain called rebound pain that can happen after regional anaesthesia. Regional anaesthesia is a method used to numb a specific area of the body during surgery by blocking nerves. In this case, a popliteal sciatic nerve block is used, which numbs the lower leg and foot by blocking a large nerve behind the knee. When this numbing effect wears off, some patients experience a sudden return of intense pain, which is called rebound pain. The treatment being studied is dexamethasone, a medication that belongs to a group of medicines called corticosteroids, which can help reduce inflammation and pain. The study will compare two different amounts of this medication given through a vein to see which dose works better at preventing rebound pain.

The purpose of the study is to find out whether a lower dose or a medium dose of dexamethasone given through an intravenous injection, which means directly into a vein, is more effective at reducing the occurrence of rebound pain after foot surgery. Patients in this study will undergo open orthopedic foot surgery, which is a type of surgery where the surgeon makes an incision to access and repair structures in the foot. The surgery will be performed on an outpatient basis, meaning patients can go home the same day rather than staying overnight in the hospital. All patients will receive the nerve block for pain control during surgery, and they will also receive one of the two doses of dexamethasone to help prevent severe pain from returning suddenly when the nerve block wears off.

During the study, patients will have their pain levels checked at specific times after surgery through telephone calls at 24 hours, 48 hours, and 72 hours following the procedure. Pain will be measured using a scale where zero means no pain and ten means the worst pain imaginable. The study will track when patients first feel pain at the surgical site after the nerve block stops working, and will also monitor for any unwanted effects related to the medication, such as high blood sugar levels measured before patients leave the hospital, or problems with wound healing that might occur up to one month after surgery.

1 Receiving dexamethasone treatment

During the surgical procedure, you will receive dexamethasone sodium phosphate through an intravenous line (a small tube inserted into a vein). This medication is administered as a solution for injection.

The medication is given to help prevent severe pain that may occur after the nerve block wears off. The specific dose you receive will be determined by the study protocol, but you will receive either a low or intermediate dose.

The nerve block used for the surgery is called a popliteal sciatic nerve block, which numbs the area around your foot by blocking the sciatic nerve behind your knee.

2 Monitoring blood sugar before discharge

Before you leave the hospital, your blood sugar level will be measured using a small finger prick test. This is done to check for any significant increase in blood sugar, which can sometimes occur as a side effect of dexamethasone.

The medical team will check if your blood sugar level is above 180 mg/dl. If it is elevated, appropriate measures will be taken.

3 Telephone follow-up at 24 hours

At 24 hours after the nerve block was performed, you will receive a telephone call to assess your pain level and recovery.

You will be asked to rate your pain using the Numerical Rating Scale, where 0 means no pain and 10 means the worst pain imaginable. You will have been instructed on how to use this scale before leaving the hospital.

You will also be asked about when you first felt pain at the surgical site after the nerve block began to wear off. This helps determine how long the nerve block lasted.

4 Telephone follow-up at 48 hours

At 48 hours after the nerve block, you will receive another telephone call with similar questions about your pain level.

You will again rate your pain using the Numerical Rating Scale from 0 to 10.

If you have not yet experienced pain onset, you will be asked about when pain first began at the surgical site.

5 Telephone follow-up at 72 hours

At 72 hours after the nerve block, you will receive a final telephone call to assess your pain level.

You will rate your pain once more using the Numerical Rating Scale.

This call will also address any remaining questions about when pain first began if this has not yet been established.

6 Monitoring for surgical complications

During the month following your surgery, the medical team will monitor for any signs of surgical site infection or delayed wound healing.

This monitoring is part of the safety assessment to detect any potential side effects related to the dexamethasone treatment.

You should report any unusual symptoms, such as increased redness, swelling, discharge from the wound, or prolonged healing, during your routine follow-up appointments.

Who Can Join the Study?

You must be an adult patient, which means you are 18 years of age or older
You must have an ASA physical status of I, II, or III, which is a way doctors classify your overall health condition before surgery, ranging from healthy patients to those with moderate health problems
You must be scheduled for planned foot surgery that involves opening the skin to repair bones or joints in your foot
Your surgery must be performed as an outpatient procedure, meaning you will go home the same day and will not stay overnight in the hospital
Your surgery must be performed using a popliteal sciatic nerve block, which is a type of pain control where medicine is injected near a nerve behind your knee to numb your foot during and after surgery

Who Cannot Join the Study?

No exclusion criteria have been specified for this clinical trial in the available information.

Where you can join this trial?

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Site Name	City	Country	Status
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.10.2025

Trial locations

Investigated drugs:

Dexamethasone Sodium Phosphate

Dexamethasone is a steroid medication that helps reduce inflammation and pain. In this trial, it is given through an intravenous line (a small tube inserted into a vein) to help prevent severe pain that can occur when the numbing medicine from the nerve block wears off after foot surgery.

Popliteal sciatic nerve block is a numbing procedure where local anesthetic medication is injected near a major nerve behind the knee. This temporarily blocks pain signals from the foot and lower leg during and after surgery, allowing patients to have foot surgery without feeling pain in that area.

Investigated diseases:

Procedural pain

Postoperative Pain – Postoperative pain is discomfort that occurs after a surgical procedure. It develops as a natural response to tissue damage caused during surgery. The pain typically begins as the anesthetic wears off and the body starts to regain sensation in the operated area. The intensity can vary depending on the type and extent of the surgery performed. Pain levels may be highest in the first few days following the procedure and gradually decrease as healing progresses. Without proper management, this pain can interfere with recovery and daily activities.

Rebound Pain – Rebound pain is a sudden increase in pain intensity that occurs after the effects of regional anesthesia wear off. This condition develops when a nerve block used during surgery stops working and sensation returns to the affected area. The pain often appears more severe than typical postoperative pain and can occur within hours to days after the procedure. Patients may experience a sharp transition from complete pain relief to significant discomfort. The intensity of rebound pain can be distressing and may require additional pain management. This phenomenon is particularly common after procedures involving nerve blocks in the limbs.

Trial ID:

2025-523356-31-01

Protocol code:

DexaRP

Trial Phase:

Human Pharmacology (Phase I) – Other

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Comparing Low and Intermediate Doses of Dexamethasone for Rebound Pain After Foot Surgery in Patients Receiving Nerve Block Anesthesia

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