A Phase 4 interventional study of Dexamethasone lipid microsphere plus ropivacaine and Ropivacaine alone in Pain, Postoperative, sponsored by Beijing Tiantan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Prevention
According to recent studies, patients following craniotomy suffer more than minimal pain; two-thirds of patients experienced moderate to severe pain. Postoperative pain most often occurs within 48 hours after surgery. Local infiltration of anesthesia is the most simple and effective analgesia. However, the analgesic effect only lasts for a short-time after surgery, and it cannot adequately meet the needs of postoperative analgesia after craniotomy. Several studies have shown that the mixture of dexamethasone with local anesthetics could reduce the postoperative pain scores better than local anesthetics alone. Lipid microsphere is a relatively new drug delivery system. It is an artificial lipid emulsion. Studies have shown that dexamethasone lipid microsphere, the dexamethasone palmitate emulsion (D-PAL emulsion), has stronger anti-inflammatory effect than dexamethasone. Therefore, the investigators hypothesize that the pre-emptive scalp infiltration with dexamethasone lipid microsphere plus ropivacaine could achieve superior postoperative pain-relief compared to ropivacaine alone for patients undergoing craniotomy.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 130 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Drug: Dexamethasone lipid microsphere plus ropivacaine
Drug: Ropivacaine alone
Local scalp infiltration solution will consist of 30ml miscible liquids containing 8 mg dexamethasone lipid microsphere, 150mg ropivacaine and normal saline.
Also known as: ropivacaine plus D-PAL
Local scalp infiltration solution will consist of 30ml miscible liquids containing 150mg ropivacaine and normal saline
The pain NRS scores at 24 h after craniotomy
The numeral rating scale allows a person to describe the intensity of the pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be".
Time frame: At 24 hours after the operation
The first time the patients press the PCA button
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. The PCA device 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 24, 48,72 hours postoperatively
The number of patients who didn't press the PCA button
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. The PCA device 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 24, 48, 72 hours postoperatively
The number of times patients press the PCA button
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. The PCA device 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 24, 48, 72 hours postoperatively
The NRS score
The numeral rating scale allows a person to describe the intensity of the pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be".
Time frame: At 2 hours, 4 hours, 12 hours, 48 hours, 72 hours, 1 month, and 3 months after the operation
The incidence of PONV
Postoperative nausea and vomiting: 0 represents absent; 1 represents nausea without treatment; 2 represents nausea in need of treatment; 3 represents vomiting
Time frame: Within 24, 48, 72 hours after surgery
Time to first rescue analgesia with OC/APAP after surgery
Patients will be given an oral supplementary tablet of oxycodone (OC)/acetaminophen (APAP) 5/325-mg (MallinckrodtInc.USA) for rescue analgesia when NRS score \> 4 after receiving four times of bolus with the PCA device. OC/ APAP will be prescribed at an interval of at least 6 h until the end of our study.
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively
Duration of hospitalization
From the date of the surgery until the date of discharge
Time frame: From the date of the surgery until the date of discharge, assesses up to 7 days
WHOQOL-BREF scores
The World Health Organization QoL abbreviated version scale consists of 26 items and involves 4 aspects: A. Physical health (7 items); B. Psychological health (6 items); C. Social relationships (3 items); D. Environment (8 items). Other two items measure the patients' quality of life and general health. The average score for each domain can range from 4 to 20, and the higher the score, the better the quality of life.
Time frame: At 1 month and 3 months after surgery
Wound healing scores
Wound healing scores： 1 represents skin fully healed, no infection, hair regrowth along wound; 2 represents skin ≤3cm in total not healed, ≤0.5cm margin of redness, hair ≤3cm not regrowthing; 3 represents skin \>3cm not healed, more redness or superficial pus, \>3-6cm not regrowthing hair; 4 represents areas of necrosis ≤3cm, deep infection, \>6cm not regrowthing hair; 5 represents areas of necrosis \>3cm.
Time frame: At 1 and 3 months after surgery
POSAS scores
The Patient and Observer Scar Assessment Scale consists of two scales: the observer scale and the patient scale. Both scales contain six items that are scored numerically. Each of the six items on both scales has a 10-step score, with 10 indicating the worst imaginable scar or sensation. The total score of both scales consists of adding the scores of each of the six items (range, 6 to 60). The lowest score, 6, reflects normal skin, whereas the highest score, 60, reflects the worst imaginable scar.
Time frame: At 3 months after surgery
Adverse events
Steroid-hormone related complications, such as wound infection, wound edema, delayed wound healing, pulmonary infections, gastric ulcers, local atrophy or infection, embolic events and so on
Time frame: Through the whole follow-up, an average of 3 months
Cumulative sufentanil consumption by PCA device
A Patient Controlled Analgesia (PCA) device containing sufentanil 200μg and ondansetron 16 mg in 100 ml saline will be set up to deliver 1 mL as an intravenous bolus with a 10-min lockout interval after craniotomy. The maximum dose will be limited to 8 μg per hour, and there will be no initial dose or background infusion. Patients will be advised to push the analgesic demand button if they feel pain and to repeat it until the pain is relieved.
Time frame: During 24hours, 48 hours and 72 hours postoperatively
Plan to share: Yes
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital