- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06321354
Pre-emptive Infiltration of the Scalp With Diprospan Plus Ropivacaine for Pain After Craniotomy in Children
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. Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy.
Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luo Fang, M.D
- Phone Number: +86 13611326978
- Email: 13611326978@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100070
- Recruiting
- Beijing Tiantan Hospital
-
Contact:
- Luo Fang, M.D
- Phone Number: +86 13611326978
- Email: 13611326978@163.com
-
Beijing, Beijing, China, 100045
- Recruiting
- Beijing Children's hospital affiliated to capital medical university
-
Contact:
- Ge Ming, M.D
- Phone Number: 010-59616408
- Email: geming88@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of allergies to any of the study drugs; 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; Body mass index exceeded the 99th percentile for age; Children who must use a patient-controlled analgesia (PCA) device; Children who cannot understand an instruction of pain scales before surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The diprospan plus ropivacaine group
Patients in the diprospan plus ropivacaine group will receive a peri-incisional scalp infiltration with 15ml diprospan and 15mg of 1% ropivacaine and normal saline miscible liquids.
|
The local infiltration solution containing 0.5ml diprospan and 15mg of 1% ropivacaine.
The total volume is 30 ml.
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.
|
Active Comparator: The ropivacaine group
Patients in the ropivacaine group will receive a peri-incisional scalp infiltration with 15mg of 1%
|
The local infiltration solution containing 15mg of 1% ropivacaine.
The total volume is 30 ml.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)
Time Frame: At 24 hours after the operation
|
Postoperative pain will be estimated by using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS).
0 indicates no pain, 10 indicates the most severe pain imaginable.
|
At 24 hours after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Healing Score
Time Frame: At 1 month after surgery
|
Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis >3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable
|
At 1 month after surgery
|
Heart rate
Time Frame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
|
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
|
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
|
During procedure
|
|
The total consumption of anaesthetic during the operation
Time Frame: During procedure
|
During procedure
|
|
The time to the first rescue analgesic
Time Frame: Within 48 hours after the operation
|
Rescue analgesics will be administered if the patient exhibits signs of sympathetic stimulation in the form of undue tachycardia, a rise in mean arterial pressure (rise of >20% from the baseline), and mCHEOPS score above 5 (range 1 to 10) or if the children are in obvious pain and distress at any time point during a subjective assessment by the intensivist or parents.
|
Within 48 hours after the operation
|
The occurrence of postoperative nausea and vomiting (PONV)
Time Frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
|
PONV will be rated by participants as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
|
At 2 hours, 4 hours, 8 hours, 24 hours after surgery
|
Ramsay Sedation Scale (RSS)
Time Frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
|
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.
|
At 2 hours, 4 hours, 8 hours, 24 hours after surgery
|
The occurrence of respiratory depression
Time Frame: Within 48 hours after the operation
|
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.
|
Within 48 hours after the operation
|
modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)
Time Frame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
|
Postoperative pain will be estimated by using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS).
0 indicates no pain, 10 indicates the most severe pain imaginable.
|
At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
|
Patient satisfactory scale (PSS)
Time Frame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
|
0 for unsatisfactory, and 10 for very satisfied
|
At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
|
Length of stay (LOS)
Time Frame: Approximately 1 weeks after the operation
|
LOS will be recorded as the number of nights spent in hospital after surgery.
|
Approximately 1 weeks after the operation
|
Incisional related adverse events
Time Frame: Approximately 1 weeks after the operation
|
Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.
|
Approximately 1 weeks after the operation
|
The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Within 1 weeks after the operation
|
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.
|
Within 1 weeks after the operation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Luo Fang, M.D, Beijing Tiantan Hospital
- Principal Investigator: Ge Ming, M.D, Beijing Children's hospital affiliated to capital medical university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anesthetics, Local
- Ropivacaine
- Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Other Study ID Numbers
- KY 2018-066-02-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on The diprospan plus ropivacaine group
-
Chinese University of Hong KongRecruitingObesity | Gastro Esophageal Reflux DiseaseChina
-
Second Affiliated Hospital, School of Medicine,...Unknown
-
University of ValenciaAsociación de Fibrosis Quística - Comunidad ValencianaNot yet recruiting
-
Peking Union Medical College HospitalRecruitingAutoimmune DiseasesChina
-
Beijing Tiantan HospitalBeijing Children's HospitalCompletedPain, Postoperative | ChildrenChina
-
University of South CarolinaCompletedOverweight | Body Weight ChangesUnited States
-
Seoul National University HospitalRecruitingDiabetic Foot | Diabetic NeuropathiesKorea, Republic of
-
M.D. Anderson Cancer CenterRecruitingPain | Pain Syndrome | Symptom ManagementUnited States
-
Region SkanePfizerCompleted
-
The Affiliated Hospital of Qingdao UniversityEnrolling by invitation