Pain, PostoperativePhase 4NCT03636165
Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Post-Craniotomy Pain in Children
A Phase 4 study testing Methylprednisolone and Ropivacaine in people with Pain, Postoperative and Post-Craniotomy Headache, run by Beijing Tiantan Hospital.
Trial summary
At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pain, Postoperative, Post-Craniotomy Headache
- What is being tested?
- Methylprednisolone and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- An elective craniotomy under general anesthesia;
- American Society of Anesthesiologists (ASA) physical status of I or II;
- Participates with an anticipated fully recovery within 2 hours postoperatively；
- Informed consent by parent(s) and/or legal guardian.
Who cannot join
- History of allergies to any of the study drugs;
- Excessive alcohol or drug abuse, chronic opioids use (more than 2 weeks or 3 days per week for more than 1 month), or drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids；
- Psychiatric disorders;
- Uncontrolled epilepsy;
- Chronic headache;
- Peri-incisional infection;
Show all 9Show fewer
- Body mass index exceeded the 99th percentile for age;
- Children who cannot use patient-controlled intravenous analgesia(PCIA) device;
- Children who cannot understand an instruction of pain scales before surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP)
At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.
- Conditions
- Pain, Postoperative, Post-Craniotomy Headache
- Being tested
- Methylprednisolone, Ropivacaine
- Keywords
- Postoperative Pain, Post-Craniotomy Headache, Methylprednisolone, Ropivacaine, Pre-emptive Scalp Infiltration, Child
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The local infiltration solution containing 1.25mg Methylprednisolone per milliliter.
RopivacaineDrug
The local infiltration solution containing 2mg Ropivacaine per milliliter.
| Study group | Role | What they receive |
|---|---|---|
| MP plus RP group | Experimental | Patients in RP/MP group will receive a peri-incisional scalp infiltration with 0.125% methylprednisolone and 0.2% ropivacaine and normal saline miscible liquids. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators. Receives: Drug: Methylprednisolone; Drug: Ropivacaine |
| RP group | Active comparator | Patients in RP group will receive peri-incisional scalp infiltration with 0.2% ropivacaine alone. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative fentanyl consumption within 24 hours postoperatively
The PCIA device provides bolus (0.5µg/kg, 10min lock-out time) and the maximum dose will be limited as 2µg/kg per hour. If the patients feel inadequate analgesia after 5 times of fentanyl bolus, the bolus dose will be increased to 1 µg/kg and the maximum dose will be increased to 4 µg/kg per hour
Measured: Within 24 hours after the operation
Secondary outcomes (17)
The number of participants who have no fentanyl consumption
The number of participants who have not pushed the button of patient-controlled intravenous analgesia pump. Both of the initial dose and background infusion of the patient-controlled intravenous analgesia pump in this study will be set at 0. Participants will be advised to push the analgesic demand button if they feel pain.
Measured: Within 24 hours after the operation
The first time to press the patient-controlled intravenous analgesia button
The first time that the participants press the patient-controlled intravenous analgesia button.
Measured: Within 24 hours after the operation
The total times that participants press patient-controlled intravenous analgesia button
The total times that participants press patient-controlled intravenous analgesia button including effective presses and ineffective presses.
Measured: Within 24 hours after the operation
Numeric Rating Scale (NRS)
The NRS is a segmented numeric scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. (0 indicates no pain, 10 indicates the most severe pain imaginable. Significant or moderate pain will be defined as NRS ≥4. Severe pain will be defined as a pain score ≥7.
Measured: At 2 hours, 4 hours, 8 hours, 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
Pain control satisfaction score(PCSS)
PCSS (0 for unsatisfactory, and 10 for very satisfied) will be assessed patient satisfaction
Measured: At 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
length of stay (LOS)
LOS will be recorded as the number of nights spent in hospital after surgery.
Measured: At 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
The occurrence of postoperative nausea and vomiting
Postoperative nausea and vomiting (PONV) was rated by participants as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Measured: The duration of hospitalization after the operation
Ramsay Sedation Scale（RSS）
1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.Oversedation will be defined as a score of >2
Measured: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
The time to first water and oral intake request, scales of oral intake after operation
Measured: Within 24 hours after the operation
The occurrence of respiratory depression
Respiratory depression is defined as persistent (more than 1 minutes) oxygen desaturation 90 percent or respiratory rate less than 8 breaths per minute, or oxygen desaturation less than 94 percent along with respiratory rate less than 10 breaths per minute requiring supplemental oxygen to maintain oxygen saturation more than 94 percent in the absence of clinically obvious upper airway obstruction.
Measured: Within 24 hours after the operation
Emergence delirium
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. (1) The child makes eye contact with the caregiver, (2) the child's actions are purposeful, (3) the child is aware of his/her surroundings, (4) the child is restless, and (5) the child is inconsolable. Items 1, 2, and 3 are reversed scored as follows: 4 not at all, 3 just a little, 2 quite a bit, 1 very much, 0 extremely. Items 4 and 5 are scored as follows: 0 not at all, 1 just a little, 2 quite a bit, 3 very much, 4 extremely. The scores of each item were summed to obtain a total PAED scale scores. Emergence agitation will be considered a total score of >12 at any time.
Measured: Within 24 hours after the operation
Heart rate
Measured: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
Mean arterial pressure
Measured: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
The total consumption of opioids during the operation
Measured: During procedure
The total consumption of anaesthetic during the operation
Measured: During procedure
Incisional related adverse events
Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.
Measured: Within 1 month after surgery
The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)
An AE was defined as any untoward medical occurrence. An SAE included death, immediately life-threatening conditions, coma, in-patient hospitalisation or prolongation of existing hospitalisation.
Measured: Within 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Sep 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 90 participants (estimated)
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, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636165
- Sponsor's protocol ID
- KY 2018-066-02-1
- Status last verified
- Oct 2021
- First submitted
- 2 Aug 2018
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao C, Jia Y, Jia Z, Xiao X, Luo F. Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial. BMJ Open. 2019 Jun 22;9(6):e027864. doi: 10.1136/bmjopen-2018-027864.
PubMed 31230016
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP)
- ClinicalTrials.gov ID
- NCT03636165
- Acronym / sponsor ID
- KY 2018-066-02-1
- Conditions
- Pain, Postoperative, Post-Craniotomy Headache
- Keywords
- Postoperative Pain, Post-Craniotomy Headache, Methylprednisolone, Ropivacaine, Pre-emptive Scalp Infiltration, Child
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Aug 2018 (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.
At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MP plus RP group | Experimental | Drug: Methylprednisolone, Drug: RopivacainePatients in RP/MP group will receive a peri-incisional scalp infiltration with 0.125% methylprednisolone and 0.2% ropivacaine and normal saline miscible liquids. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators. |
| RP group | Active comparator | Drug: RopivacainePatients in RP group will receive peri-incisional scalp infiltration with 0.2% ropivacaine alone. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- An elective craniotomy under general anesthesia;
- American Society of Anesthesiologists (ASA) physical status of I or II;
- Participates with an anticipated fully recovery within 2 hours postoperatively；
- Informed consent by parent(s) and/or legal guardian.
Key exclusion criteria (9 listed)
- History of allergies to any of the study drugs;
- Excessive alcohol or drug abuse, chronic opioids use (more than 2 weeks or 3 days per week for more than 1 month), or drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids；
- Psychiatric disorders;
- Uncontrolled epilepsy;
- Chronic headache;
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 |
|---|---|---|
| MethylprednisoloneThe local infiltration solution containing 1.25mg Methylprednisolone per milliliter. | Drug | MP plus RP group |
| RopivacaineThe local infiltration solution containing 2mg Ropivacaine per milliliter. | Drug | MP plus RP group, RP group |
Primary outcome
Cumulative fentanyl consumption within 24 hours postoperatively
Time frame: Within 24 hours after the operation
The PCIA device provides bolus (0.5µg/kg, 10min lock-out time) and the maximum dose will be limited as 2µg/kg per hour. If the patients feel inadequate analgesia after 5 times of fentanyl bolus, the bolus dose will be increased to 1 µg/kg and the maximum dose will be increased to 4 µg/kg per hour
17 secondary outcomes
The number of participants who have no fentanyl consumption
Time frame: Within 24 hours after the operation
The first time to press the patient-controlled intravenous analgesia button
Time frame: Within 24 hours after the operation
The total times that participants press patient-controlled intravenous analgesia button
Time frame: Within 24 hours after the operation
Numeric Rating Scale (NRS)
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
Pain control satisfaction score(PCSS)
Time frame: At 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
length of stay (LOS)
Time frame: At 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
The occurrence of postoperative nausea and vomiting
Time frame: The duration of hospitalization after the operation
Ramsay Sedation Scale（RSS）
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
The time to first water and oral intake request, scales of oral intake after operation
Time frame: Within 24 hours after the operation
The occurrence of respiratory depression
Time frame: Within 24 hours after the operation
Emergence delirium
Time frame: Within 24 hours after the operation
Heart rate
Time frame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
Mean arterial pressure
Time frame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
The total consumption of opioids during the operation
Time frame: During procedure
The total consumption of anaesthetic during the operation
Time frame: During procedure
Incisional related adverse events
Time frame: Within 1 month after surgery
The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Within 6 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 31230016Zhao C, Jia Y, Jia Z, Xiao X, Luo F. Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial. BMJ Open. 2019 Jun 22;9(6):e027864. doi: 10.1136/bmjopen-2018-027864.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone and Ropivacaine in people with Pain, Postoperative and Post-Craniotomy Headache, run by Beijing Tiantan Hospital.
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 4 inclusion and 9 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Fang Luo, MD (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative fentanyl consumption within 24 hours postoperatively (time frame: Within 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 NCT03636165, which also lists 1 linked publication.
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 27 Oct 2021.