A Phase 4 interventional study of Dexamethasone palmitate emulsion(DXP) plus ropivacaine and Ropivacaine alone in Pain, Postoperative, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Prevention
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 124 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine.
Drug: Dexamethasone palmitate emulsion(DXP) plus ropivacaine
The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.
Drug: Ropivacaine alone
The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of ropivacaine and dexamethasone palmitate emulsion(DXP). For local infiltration, a total of 30mL solution will be prepared for each group, which will include 2mL of DXP(4mg per 1mL) added to 20.5 mL of saline and 7.5mL of 1% ropivacaine added to 15mL of saline for Group A . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.
Also known as: DXP plus ropivacaine
The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone. For local infiltration, a total of 30mL solution will be prepared for each group, which will include 7.5mL of ropivacaine added to 22.5mL of saline for Group B . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.
The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.
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.
Time frame: Within 24 hours after spinal surgery
The cumulative consumption of sufentanil via PCA pump between 24 hours and 48 hours postoperatively.
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.
Time frame: Between 24 hours and 48 hours after spinal surgery
Number of patients without PCA press button
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.
Time frame: Within 48 hours after spinal surgery
The time of first PCA demand
The first time that the participants press PCA button.
Time frame: Within 48 hours after spinal surgery
The total number of PCA presses including both valid and invalid presses
The total number that participants press PCA button including valid and invalid presses
Time frame: Within 48 hours after spinal surgery
Postoperative visual analogue scale (VAS) score during movement(VASm)
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)
Time frame: At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively
Postoperative VAS score at rest(VASr)
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)
Time frame: 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
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).
Time frame: 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)
Patient Satisfaction Score (PSS) with pain relief
4 scales; never, sometimes, usually or always
Time frame: At 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks 1 month and 3 months postoperatively
Postoperative nausea and vomiting (PONV) score
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.
Time frame: At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
Ramsay Sedation Scale (RSS)
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.
Time frame: At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)
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.
Time frame: At 2 weeks, 1 month and 3 months postoperatively
Rate of steroid-related side effects and complications
Steroid-related side effects (hyperglycemia, gastrointestinal bleeding, gastritis, etc.) or complications including any cardiac, respiratory, renal, neurologic, or infection complications occured during the hospitalization
Time frame: Through the whole follow-up, an average of 3 months
Readmission rate within 3 months after spine surgery;
Patients readmitted within 3 months after spine surgery
Time frame: Through the whole follow-up, within 3 months after spine surgery
Length of Postoperative Anesthesia Care Unit (PACU) stay
Time from arrival at PACU after tracheal extubation to transfer from PACU to the surgical ward (modified Aldrete score ≥9).
Time frame: Approximately 30 minutes to 2 hours after surgery
Duration of hospitalization after surgery
Duration of hospitalization after surgery (time required from the end of surgery to discharge from the hospital).
Time frame: Approximately 1-2 weeks after surgery
Total consumption of remifentanil during surgery
Total remifentanil dosages during surgery
Time frame: During surgery
Total consumption of loxoprofen
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.
Time frame: From postoperative 48 hours to approximately 1-2 weeks after surgery
Plan to share: Yes
Supporting information: Study protocol
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Beijing Tiantan Hospital