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

Capital Medical University

Status: Enrolling

Conditions: Spine Surgery; Pain Management

Treatments: Drug: 0.003%diprospan+0.5%ropivacaine; Drug: 0.5%ropivacaine; Drug: 0.009%diprospan+0.5%ropivacaine; Drug: 0.006%diprospan+0.5ropivacaine; Drug: 0.012%diprospan+0.5%ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06785350

KY2024-365-02-1

Details and patient eligibility

About

Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory/cardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.

Enrollment: 535 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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535 participants in 5 patient groups

intervention group 1

Experimental group

Description:

0.012%diprospan+0.5%ropivacaine

Treatment:

Drug: 0.012%diprospan+0.5%ropivacaine

intervention group 2

Experimental group

Description:

0.009%diprospan+0.5%ropivacaine

Treatment:

Drug: 0.009%diprospan+0.5%ropivacaine

intervention group 3

Experimental group

Description:

0.006%diprospan+0.5%ropivacaine

Treatment:

Drug: 0.006%diprospan+0.5ropivacaine

intervention group 4

Experimental group

Description:

0.003%diprospan+0.5%ropivacaine

Treatment:

Drug: 0.003%diprospan+0.5%ropivacaine

control group

Active Comparator group

Description:

0.5%ropivacaine

Treatment:

Drug: 0.5%ropivacaine