Preemptive Co-infiltration of Dexamethasone Palmitate Emulsion With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery
Overview
- Phase
- Phase 4
- Intervention
- Dexamethasone palmitate emulsion(DXP) plus ropivacaine
- Conditions
- Pain, Postoperative
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Fang Luo
Director of Department of Day Surgery and Pain Management
Beijing Tiantan Hospital
Eligibility Criteria
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;
Arms & Interventions
The dexamethasone palmitate emulsion(DXP) plus ropivacaine group
The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine.
Intervention: Dexamethasone palmitate emulsion(DXP) plus ropivacaine
The ropivacaine alone group
The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.
Intervention: Ropivacaine alone
Outcomes
Primary Outcomes
The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.
Time Frame: Within 24 hours after spinal surgery
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) pump. Participates will be advised to push the analgesic demand button if they feel pain.
Secondary Outcomes
- The time of first PCA demand(Within 48 hours after spinal surgery)
- Patient Satisfaction Score (PSS) with pain relief(At 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks 1 month and 3 months postoperatively)
- Duration of hospitalization after surgery(Approximately 1-2 weeks after surgery)
- Postoperative VAS score at rest(VASr)(At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively)
- Total consumption of Tylenol as supplementary analgesia(Four separate postoperative periods ( 0- postoperative 48 hours, postoperative 48 hours-postoperative 2 weeks, postoperative 2 weeks-postoperative 1 month, and postoperative 1 month-postoperative 3 months))
- Rate of steroid-related side effects and complications(Through the whole follow-up, an average of 3 months)
- Readmission rate within 3 months after spine surgery;(Through the whole follow-up, within 3 months after spine surgery)
- The cumulative consumption of sufentanil via PCA pump between 24 hours and 48 hours postoperatively.(Between 24 hours and 48 hours after spinal surgery)
- Number of patients without PCA press button(Within 48 hours after spinal surgery)
- The total number of PCA presses including both valid and invalid presses(Within 48 hours after spinal surgery)
- Ramsay Sedation Scale (RSS)(At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively)
- Postoperative visual analogue scale (VAS) score during movement(VASm)(At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively)
- Postoperative nausea and vomiting (PONV) score(At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively)
- Total consumption of loxoprofen(From postoperative 48 hours to approximately 1-2 weeks after surgery)
- Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)(At 2 weeks, 1 month and 3 months postoperatively)
- Length of Postoperative Anesthesia Care Unit (PACU) stay(Approximately 30 minutes to 2 hours after surgery)
- Total consumption of remifentanil during surgery(During surgery)