Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Dexamethasone palmitate emulsion(DXP) plus ropivacaine
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 13mL of saline and 15mL 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.
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| Active Comparator: The ropivacaine alone group The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone. |
Drug: Ropivacaine alone
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 15mL of ropivacaine added to 15mL 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.
|
Outcome Measures
Primary Outcome Measures
- The cumulative consumption of sufentanil within 48 hours after spinal surgery via the PCA pump. [Within 48 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
- 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 time of first PCA demand [Within 48 hours after spinal surgery]
The first time that the participants press PCA button.
- 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
- Postoperative visual analogue scale (VAS) score during movement(VASm) [At 2 hours, 4 hours, 24 hours, 48 hours, 2 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 VAS score at rest(VASr) [At 2 hours, 4 hours, 24 hours, 48 hours, 2 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 acetaminophen as rescue 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 rescue analgesia, taking acetaminophen 500-1000mg orally at a minimum interval of 6 hours, and a maximum daily dose of 2000mg. After the initial postoperative 48 hours, patients will be allowed to take oral acetaminophen as needed (dose as previously described), until the end of the study (3-months follow-up).
- Patient Satisfaction Score (PSS) with pain relief [At 48 hours, 2 weeks, 1 month and 3 months postoperatively]
4 scales; never, sometimes, usually or always
- Postoperative nausea and vomiting (PONV) score [At 2 hours, 4 hours, 24 hours, and 48 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.
- Ramsay Sedation Scale (RSS) [At 2 hours, 4 hours, 24 hours, and 48 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.
- 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.
- The Oswestry Disability Index (ODI) [preoperatively and at 2 weeks,1 month and 3 months postoperatively]
Functional disability will be assessed by the Oswestry Disability Index. It includes 10 questions about pain and activities of daily living. Each item has five response categories from no pain related disability (0), to the worst possible pain disability (100). The ODI has been reported to be the most widely used and validated outcome measure in spinal surgery.
- Side effects and complications [Through the whole follow-up, an average of 3 months]]
Steroid-related side effects (hyperglycemia, gastrointestinal bleeding, gastritis, etc.) and complications including any cardiac, respiratory, renal, neurologic, or infection complications during the hospitalization
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-64 years;
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Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia
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American Society of Anesthesiologists (ASA) physical status of I-III;
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Anticipated full recovery and cooperation within 2 hours postoperatively.
Exclusion Criteria:
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History of spinal surgery;
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Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS);
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Body mass index (BMI)<15kg/m2 or >35kg/m2;
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Peri-incisional infection;
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History of severe cardiopulmonary, hepatic or renal dysfunction;
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Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value);
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History of allergies to any of the study drugs;
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History of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery;
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Use of systemic steroids within 1 week before surgery;
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History of psychiatric disorders, chronic neck or back pain;
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History of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively;
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Pregnant or breastfeeding;
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Refusal to sign informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tiantan Hospital | Beijing | Beijing | China | 100070 |
Sponsors and Collaborators
- Beijing Tiantan Hospital
Investigators
- Principal Investigator: Fang Luo, Beijing Tiantan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Bai JW, An D, Perlas A, Chan V. Adjuncts to local anesthetic wound infiltration for postoperative analgesia: a systematic review. Reg Anesth Pain Med. 2020 Aug;45(8):645-655. doi: 10.1136/rapm-2020-101593. Epub 2020 May 30.
- Han X, Ren T, Wang Y, Ji N, Luo F. Postoperative Analgesic Efficacy and Safety of Ropivacaine Plus Diprospan for Preemptive Scalp Infiltration in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1253-1261. doi: 10.1213/ANE.0000000000005971. Epub 2022 Mar 21.
- Kjaergaard M, Moiniche S, Olsen KS. Wound infiltration with local anesthetics for post-operative pain relief in lumbar spine surgery: a systematic review. Acta Anaesthesiol Scand. 2012 Mar;56(3):282-90. doi: 10.1111/j.1399-6576.2011.02629.x. Epub 2012 Jan 19.
- Lamperti M, Tufegdzic B, Avitsian R. Management of complex spine surgery. Curr Opin Anaesthesiol. 2017 Oct;30(5):551-556. doi: 10.1097/ACO.0000000000000494.
- Shrestha N, Han B, Wang X, Jia W, Luo F. Methylprednisolone as an Adjunct to Local Infiltration on Laminoplasty or Laminectomy before Wound Closure: A Randomized Controlled Trial. Pain Res Manag. 2022 Aug 3;2022:2274934. doi: 10.1155/2022/2274934. eCollection 2022.
- Ye X, Ren YF, Hu YC, Tan SY, Jiang H, Zhang LF, Shi W, Wang YT. Dexamethasone Does Not Provide Additional Clinical Analgesia Effect to Local Wound Infiltration: A Comprehensive Systematic Review and Meta-Analysis. Adv Wound Care (New Rochelle). 2023 Jan;12(1):1-14. doi: 10.1089/wound.2021.0163. Epub 2022 Mar 1.
- Zhao C, Wang S, Pan Y, Ji N, Luo F. Pre-Emptive Incision-Site Infiltration with Ropivacaine Plus Dexamethasone for Postoperative Pain After Supratentorial Craniotomy: A Prospective Randomized Controlled Trial. J Pain Res. 2021 Apr 19;14:1071-1082. doi: 10.2147/JPR.S300943. eCollection 2021.
- KY-2019-112-02-3