Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Ropivacaine alone; Drug: Dexamethasone palmitate emulsion(DXP) plus ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05693467

KY-2019-112-02-3

Details and patient eligibility

About

Patients undergoing major spinal surgery usually experience moderate-to-severe postoperative pain. Inadequate pain control may lead to severe complications. Dexamethasone as an adjunctive infiltration to local anesthesia (LA) presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis showed that the additional analgesic effect of dexamethasone in incision/wound infiltration was only statistically significant, but not clinically significant, and the overall benefits were marginal. Compared with dexamethasone, dexamethasone palmitate emulsion (DXP) is a targeted lipo-steroid with stronger anti-inflammatory effect, longer-acting duration and fewer adverse effects. To date, no studies have evaluated the additive analgesia effects of DXP on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of DXP emulsion and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.

Enrollment: 124 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-64 years;
• Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia
• American Society of Anesthesiologists (ASA) physical status of I-III;
• Anticipated full recovery and cooperation within 2 hours postoperatively.

Exclusion criteria

• History of spinal surgery;
• Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS);
• Body mass index (BMI)<15kg/m2 or >35kg/m2;
• Peri-incisional infection;
• History of diabetes mellitus and other metabolic diseases;
• History of severe cardiopulmonary, hepatic or renal dysfunction;
• Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value);
• History of allergies to any of the study drugs;
• History of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery;
• Use of systemic steroids within 1 week before surgery;
• History of psychiatric disorders, chronic neck or back pain;
• History of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively;
• Pregnant or breastfeeding;
• Refusal to sign informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

The dexamethasone palmitate emulsion(DXP) plus ropivacaine group

Experimental group

Description:

The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine.

Treatment:

Drug: Dexamethasone palmitate emulsion(DXP) plus ropivacaine

The ropivacaine alone group

Active Comparator group

Description:

The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.

Treatment:

Drug: Ropivacaine alone