Pain, PostoperativePhase 4NCT04488315
Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-craniotomy Pain
A Phase 4 study testing Dexamethasone lipid microsphere plus ropivacaine and Ropivacaine alone in people with Pain, Postoperative, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Dexamethasone lipid microsphere plus ropivacaine and Ropivacaine alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 25 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-emptive Scalp Infiltration With Dexamethasone Lipid Microsphere Plus Ropivacaine for Postoperative Pain After Craniotomy
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.
- Conditions
- Pain, Postoperative
- Being tested
- Dexamethasone lipid microsphere plus ropivacaine, Ropivacaine alone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone lipid microsphere plus ropivacaineDrug
Also called ropivacaine plus D-PAL
Local scalp infiltration solution will consist of 30ml miscible liquids containing 8 mg dexamethasone lipid microsphere, 150mg ropivacaine and normal saline.
Ropivacaine aloneDrug
Local scalp infiltration solution will consist of 30ml miscible liquids containing 150mg ropivacaine and normal saline
| Study group | Role | What they receive |
|---|---|---|
| The dexamethasone lipid microsphere plus ropivacaine group | Experimental | Not described Receives: Drug: Dexamethasone lipid microsphere plus ropivacaine |
| The ropivacaine alone group | Active comparator | Not described Receives: Drug: Ropivacaine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: At 24 hours after the operation
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: During 24hours, 48 hours and 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Oct 2022
- Primary completion26 Sep 2023
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Fang Luo, M.D., Principal investigator, Beijing Tian HospitalWei Zhang, MD, Principal investigator, Beijing Tian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488315
- Sponsor's protocol ID
- KY-2018-034-02-8
- Status last verified
- Nov 2023
- First submitted
- 19 Jul 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27512639Gottschalk 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.
PubMed 17410701Jia 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.
PubMed 31213883Zhang W, Li C, Zhao C, Ji N, Luo F. Pre-incisional infiltration with ropivacaine plus dexamethasone palmitate emulsion for postoperative pain in patients undergoing craniotomy: study protocol for a prospective, randomized controlled trial. Trials. 2022 Dec 12;23(1):996. doi: 10.1186/s13063-022-06936-z.
PubMed 36510271
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Scalp Infiltration With Dexamethasone Lipid Microsphere Plus Ropivacaine for Postoperative Pain After Craniotomy
- ClinicalTrials.gov ID
- NCT04488315
- Acronym / sponsor ID
- KY-2018-034-02-8
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The dexamethasone lipid microsphere plus ropivacaine group | Experimental | Drug: Dexamethasone lipid microsphere plus ropivacaine |
| The ropivacaine alone group | Active comparator | Drug: Ropivacaine alone |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone lipid microsphere plus ropivacaineAlso: ropivacaine plus D-PALLocal scalp infiltration solution will consist of 30ml miscible liquids containing 8 mg dexamethasone lipid microsphere, 150mg ropivacaine and normal saline. | Drug | The dexamethasone lipid microsphere plus ropivacaine group |
| Ropivacaine aloneLocal scalp infiltration solution will consist of 30ml miscible liquids containing 150mg ropivacaine and normal saline | Drug | The ropivacaine alone group |
Primary outcome
The pain NRS scores at 24 h after craniotomy
Time frame: 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".
12 secondary outcomes
The first time the patients press the PCA button
Time frame: Within 24, 48,72 hours postoperatively
The number of patients who didn't press the PCA button
Time frame: Within 24, 48, 72 hours postoperatively
The number of times patients press the PCA button
Time frame: Within 24, 48, 72 hours postoperatively
The NRS score
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
Time frame: Within 24, 48, 72 hours after surgery
Time to first rescue analgesia with OC/APAP after surgery
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively
Duration of hospitalization
Time frame: From the date of the surgery until the date of discharge, assesses up to 7 days
WHOQOL-BREF scores
Time frame: At 1 month and 3 months after surgery
Wound healing scores
Time frame: At 1 and 3 months after surgery
POSAS scores
Time frame: At 3 months after surgery
Adverse events
Time frame: Through the whole follow-up, an average of 3 months
Cumulative sufentanil consumption by PCA device
Time frame: During 24hours, 48 hours and 72 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 27512639Zhou 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.
- Background: PubMed 17410701Gottschalk 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.
- Background: PubMed 31213883Jia 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.
- Derived from this study: PubMed 36510271Zhang W, Li C, Zhao C, Ji N, Luo F. Pre-incisional infiltration with ropivacaine plus dexamethasone palmitate emulsion for postoperative pain in patients undergoing craniotomy: study protocol for a prospective, randomized controlled trial. Trials. 2022 Dec 12;23(1):996. doi: 10.1186/s13063-022-06936-z.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Luo, M.D. principal investigator
Beijing Tian Hospital
Wei Zhang, MD principal investigator
Beijing Tian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone lipid microsphere plus ropivacaine and Ropivacaine alone in people with Pain, Postoperative, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain NRS scores at 24 h after craniotomy (time frame: At 24 hours after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488315, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.