Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT05693467
- Lead Sponsor
- Beijing Tiantan Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The dexamethasone palmitate emulsion(DXP) plus ropivacaine group Dexamethasone palmitate emulsion(DXP) plus ropivacaine The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine. The ropivacaine alone group Ropivacaine alone The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.
- Primary Outcome Measures
Name Time Method The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump. 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 Outcome Measures
Name Time Method The time of first PCA demand Within 48 hours after spinal surgery The first time that the participants press PCA button.
Patient Satisfaction Score (PSS) with pain relief At 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks 1 month and 3 months postoperatively 4 scales; never, sometimes, usually or always
Duration of hospitalization after surgery Approximately 1-2 weeks after surgery Duration of hospitalization after surgery (time required from the end of surgery to discharge from the hospital).
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 The pain will be assessed by VAS scores at rest (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)
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) During the initial postoperative 48 hours, when VAS\>4 (either VASm or VASr) after pressing button four times with PCA pump for pain relief, patients will be treated for supplementary analgesia with oral Tylenol (Mallinckrodt Inc.), a combination of 5mg of oxycodone hydrochloride and 325mg paracetamol per tablet at a minimum interval of 6 hours. After the initial postoperative 48 hours, patients will be allowed to take oral Tylenol as needed (dose as previously described), until the end of the study (3-months follow-up).
Rate of steroid-related side effects and complications Through the whole follow-up, an average of 3 months Steroid-related side effects (hyperglycemia, gastrointestinal bleeding, gastritis, etc.) or complications including any cardiac, respiratory, renal, neurologic, or infection complications occured during the hospitalization
Readmission rate within 3 months after spine surgery; Through the whole follow-up, within 3 months after spine surgery Patients readmitted 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 Patients will use PCA device for pain management within the the first 48 hours after surgery. When the patients feel pain, the PCA button will be pressed. When the patients feel no pain, the PCA button will not be pressed. The PCA pump will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
Number of patients without PCA press button Within 48 hours after spinal surgery Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. When the patients feel no pain, the PCA button will not be pressed. The PCA pump will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
The total number of PCA presses including both valid and invalid presses Within 48 hours after spinal surgery The total number that participants press PCA button including valid and invalid presses
Ramsay Sedation Scale (RSS) At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively The Ramsay Sedation Scale (RSS): A 6-point scale will be used to assess sedation levels, with 1 indicating agitated, anxious; 2, cooperative; 3, only responds to commands; 4, strong response to glabellar tapping or noisy stimulants; 5, weak response to glabellar tapping or noisy stimulants; 6, no response.
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 The pain will be assessed by VAS scores during movement (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)
Postoperative nausea and vomiting (PONV) score At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively The Postoperative Nausea and Vomiting (PONV) will be measured using an ordinal scale, with 0 indicating no nausea;
1, mild nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting.Total consumption of loxoprofen From postoperative 48 hours to approximately 1-2 weeks after surgery Pain management will be provided via the sufentanil PCA device for the first 48 hours following surgery. After that, patients will switch to taking oral loxoprofen 60 mg at a minimum interval of 8 hours and a maximum 180mg per day as needed until discharge.
Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS) At 2 weeks, 1 month and 3 months postoperatively The POSAS consists of an Observer and a Patient Scale and includes a comprehensive list of items, based on clinically relevant scar characteristics. The observer scores six items: vascularization, pigmentation, thickness, surface roughness, pliability, and surface area. The patient scores six items: pain, pruritus, color, thickness, relief, and pliability. All included items are scored on the same polytomous 10-point scale, in which a score of 1 is given when the scar characteristic is comparable to normal skin and a score of 10 reflects the worst imaginable scar. All items are summed to give a total scar score, and therefore, a higher score represents a poorer scar quality.
Length of Postoperative Anesthesia Care Unit (PACU) stay Approximately 30 minutes to 2 hours after surgery Time from arrival at PACU after tracheal extubation to transfer from PACU to the surgical ward (modified Aldrete score ≥9).
Total consumption of remifentanil during surgery During surgery Total remifentanil dosages during surgery
Trial Locations
- Locations (1)
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital🇨🇳Beijing, Beijing, China