Optimal Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery

Launched by BEIJING TIANTAN HOSPITAL · Jan 18, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the best dosage of a medication called betamethasone, used during spinal surgery, to help prevent pain after the operation. Incisional pain, or pain at the site of the surgical cut, is a common issue that can slow down recovery and lead to other complications. The study aims to find out which concentration of betamethasone, when combined with other pain-relieving medicine, works best to reduce this pain after spine surgeries, such as those on the neck or back.

To participate in this trial, individuals need to be between 18 and 65 years old and scheduled for spine surgery under general anesthesia. They should be in good health overall, with no serious medical conditions or allergies to the medications used in the study. Participants will receive careful monitoring during and after the surgery to assess how well the treatment works in managing their pain. Importantly, those who choose to join the study can withdraw at any time if they feel it's not right for them. This trial is not yet recruiting, so it’s a good idea to discuss any questions with a healthcare provider if you think you might be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level).
• • Patients age 18-65 years. American Society of Anaesthesiologists Classification of I or II.
• Exclusion Criteria:
• • Patients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI\<15kg/m2 or\>35 kg/m2. Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score \< 15 before surgery. Unable to provide written informed consent.
• Withdrawal criteria:
• • Voluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up.
• • Reoperation during follow-up.