Pain, Postoperative
Conditions
Brief summary
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.
Interventions
DRUGDexamethasone lipid microsphere plus ropivacaine
Local scalp infiltration solution will consist of 30ml miscible liquids containing 8 mg dexamethasone lipid microsphere, 150mg ropivacaine and normal saline.
Local scalp infiltration solution will consist of 30ml miscible liquids containing 150mg ropivacaine and normal saline
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective craniotomy under general anesthesia; * Age 18-64 years; * American Society of Anesthesiologists (ASA) physical status of I or II; * Anticipated tracheal extubation, full recovery and cooperation within 2 hours postoperatively * Patients required to fix their head in a head clamp during the operation.
Exclusion criteria
* Previous history of craniotomy; * Plan to delay extubation or no plan to extubate; * Patients who cannot use the patient-controlled analgesia (PCA) device; * Patients who cannot comprehend the instructions of a numeric rating scale (NRS) before craniotomy; * Body mass index (BMI) \<15 or \>35; * Allergy to dexamethasone, lipid microsphere, opioids or ropivacaine; * History of drug abuse or excessive alcohol, chronic opioids use (more than 2 weeks), or use of any sedative or analgesic before surgery; * History of uncontrolled epilepsy, psychiatric disorders or chronic headache; * Pregnant or at breastfeeding; * Symptomatic cardiopulmonary, liver or renal dysfunction or combined with diabetes or other systemic dysfunction; * Glasgow Coma Scale \<15 before the surgery; * Intracranial hypertension; * Peri-incisional infection; * Patients who have received chemoradiotherapy before the surgery or expected to receive postoperative chemoradiotherapy according to the preoperative imaging.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pain NRS scores at 24 h after craniotomy | At 24 hours after the operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients who didn't press the PCA button | Within 24, 48, 72 hours postoperatively | 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. |
| The number of times patients press the PCA button | Within 24, 48, 72 hours postoperatively | 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. |
| The NRS score | At 2 hours, 4 hours, 12 hours, 48 hours, 72 hours, 1 month, and 3 months after the operation | 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. |
| The incidence of PONV | Within 24, 48, 72 hours after surgery | Postoperative nausea and vomiting: 0 represents absent; 1 represents nausea without treatment; 2 represents nausea in need of treatment; 3 represents vomiting |
| Time to first rescue analgesia with OC/APAP after surgery | At 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively | 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. |
| The first time the patients press the PCA button | Within 24, 48,72 hours postoperatively | 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. |
| WHOQOL-BREF scores | At 1 month and 3 months after surgery | 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. |
| Wound healing scores | At 1 and 3 months after surgery | 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. |
| POSAS scores | At 3 months after surgery | 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. |
| Adverse events | Through the whole follow-up, an average of 3 months | 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 |
| Cumulative sufentanil consumption by PCA device | During 24hours, 48 hours and 72 hours postoperatively | 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. |
| Duration of hospitalization | From the date of the surgery until the date of discharge, assesses up to 7 days | From the date of the surgery until the date of discharge |
Countries
China
Outcome results
None listed