Clinical trial NCT04488315: Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-craniotomy Pain
Official title: Pre-emptive Scalp Infiltration With Dexamethasone Lipid Microsphere Plus Ropivacaine for Postoperative Pain After Craniotomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The pain NRS scores at 24 h after craniotomy
timeFrame: At 24 hours after the operation
Secondary outcomes:
measure: The first time the patients press the PCA button
timeFrame: Within 24, 48,72 hours postoperatively
measure: The number of patients who didn't press the PCA button
timeFrame: Within 24, 48, 72 hours postoperatively
measure: The number of times patients press the PCA button
timeFrame: Within 24, 48, 72 hours postoperatively
measure: The NRS score
timeFrame: At 2 hours, 4 hours, 12 hours, 48 hours, 72 hours, 1 month, and 3 months after the operation
measure: The incidence of PONV
timeFrame: Within 24, 48, 72 hours after surgery
measure: Time to first rescue analgesia with OC/APAP after surgery
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively
measure: Duration of hospitalization
timeFrame: From the date of the surgery until the date of discharge, assesses up to 7 days
measure: WHOQOL-BREF scores
timeFrame: At 1 month and 3 months after surgery
measure: Wound healing scores
timeFrame: At 1 and 3 months after surgery
measure: POSAS scores
timeFrame: At 3 months after surgery
measure: Adverse events
timeFrame: Through the whole follow-up, an average of 3 months
measure: Cumulative sufentanil consumption by PCA device
timeFrame: During 24hours, 48 hours and 72 hours postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tian Hospital
name: Fang Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tian Hospital
name: Wei Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou H, Ou M, Yang Y, Ruan Q, Pan Y, Li Y. Effect of skin infiltration with ropivacaine on postoperative pain in patients undergoing craniotomy. Springerplus. 2016 Jul 26;5(1):1180. doi: 10.1186/s40064-016-2856-3. eCollection 2016.
citation: Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
citation: Jia Y, Zhao C, Ren H, Wang T, Luo F. Pre-emptive scalp infiltration with dexamethasone plus ropivacaine for postoperative pain after craniotomy: a protocol for a prospective, randomized controlled trial. J Pain Res. 2019 May 24;12:1709-1719. doi: 10.2147/JPR.S190679. eCollection 2019.