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Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Post-Craniotomy Pain in Children

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ClinicalTrials.gov Identifier: NCT03636165
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Fang Luo, Beijing Tiantan Hospital

Brief 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, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Post-Craniotomy Headache Drug: Methylprednisolone Drug: Ropivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: MP plus RP group
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.
Drug: Methylprednisolone
The local infiltration solution containing 1.25mg Methylprednisolone per milliliter.

Drug: Ropivacaine
The local infiltration solution containing 2mg Ropivacaine per milliliter.

Active Comparator: RP group
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.
Drug: Ropivacaine
The local infiltration solution containing 2mg Ropivacaine per milliliter.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The number of participants who have no fentanyl consumption [ Time Frame: Within 24 hours after the operation ]
    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.

  2. The first time to press the patient-controlled intravenous analgesia button [ Time Frame: Within 24 hours after the operation ]
    The first time that the participants press the patient-controlled intravenous analgesia button.

  3. The total times that participants press patient-controlled intravenous analgesia button [ Time Frame: Within 24 hours after the operation ]
    The total times that participants press patient-controlled intravenous analgesia button including effective presses and ineffective presses.

  4. 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 ]
    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.

  5. 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 ]
    PCSS (0 for unsatisfactory, and 10 for very satisfied) will be assessed patient satisfaction

  6. 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 ]
    LOS will be recorded as the number of nights spent in hospital after surgery.

  7. The occurrence of postoperative nausea and vomiting [ Time Frame: The duration of hospitalization after the operation ]
    Postoperative nausea and vomiting (PONV) was rated by participants as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.

  8. 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.Oversedation will be defined as a score of >2

  9. The time to first water and oral intake request, scales of oral intake after operation [ Time Frame: Within 24 hours after the operation ]
  10. The occurrence of respiratory depression [ Time Frame: Within 24 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.

  11. Emergence delirium [ Time Frame: Within 24 hours after the operation ]
    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.

  12. Heart rate [ Time Frame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery ]
  13. Mean arterial pressure [ Time Frame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery ]
  14. The total consumption of opioids during the operation [ Time Frame: During procedure ]
  15. The total consumption of anaesthetic during the operation [ Time Frame: During procedure ]
  16. Incisional related adverse events [ Time Frame: Within 1 month after surgery ]
    Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.

  17. The occurrence of the Adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Within 6 month after surgery ]
    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.



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. An elective craniotomy under general anesthesia;
  2. American Society of Anesthesiologists (ASA) physical status of I or II;
  3. Participates with an anticipated fully recovery within 2 hours postoperatively;
  4. Informed consent by parent(s) and/or legal guardian.

Exclusion Criteria:

  1. History of allergies to any of the study drugs;
  2. 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;
  3. Psychiatric disorders;
  4. Uncontrolled epilepsy;
  5. Chronic headache;
  6. Peri-incisional infection;
  7. Body mass index exceeded the 99th percentile for age;
  8. Children who cannot use patient-controlled intravenous analgesia(PCIA) device;
  9. Children who cannot understand an instruction of pain scales before surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636165


Contacts
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Contact: Fang Luo, MD +86 13611326978 13611326978@163.com
Contact: Hao Ren, MD +86 18710229893 renh2014@126.com

Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Fang Luo Beijing Tiantan Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fang Luo, Director of Department of Pain Management, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03636165    
Other Study ID Numbers: KY 2018-066-02-1
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fang Luo, Beijing Tiantan Hospital:
Postoperative Pain
Post-Craniotomy Headache
Methylprednisolone
Ropivacaine
Pre-emptive Scalp Infiltration
Child
Additional relevant MeSH terms:
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Headache
Pain, Postoperative
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Ropivacaine
Pharmaceutical Solutions
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents