Clinical trial NCT03636165: Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Post-Craniotomy Pain in Children
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Post-Craniotomy Headache
Keywords: Postoperative Pain
Post-Craniotomy Headache
Methylprednisolone
Ropivacaine
Pre-emptive Scalp Infiltration
Child
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Cumulative fentanyl consumption within 24 hours postoperatively
timeFrame: Within 24 hours after the operation
Secondary outcomes:
measure: The number of participants who have no fentanyl consumption
timeFrame: Within 24 hours after the operation
measure: The first time to press the patient-controlled intravenous analgesia button
timeFrame: Within 24 hours after the operation
measure: The total times that participants press patient-controlled intravenous analgesia button
timeFrame: Within 24 hours after the operation
measure: Numeric Rating Scale (NRS)
timeFrame: 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
measure: Pain control satisfaction score(PCSS)
timeFrame: At 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
measure: length of stay (LOS)
timeFrame: At 24 hours，48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
measure: The occurrence of postoperative nausea and vomiting
timeFrame: The duration of hospitalization after the operation
measure: Ramsay Sedation Scale（RSS）
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
measure: The time to first water and oral intake request, scales of oral intake after operation
timeFrame: Within 24 hours after the operation
measure: The occurrence of respiratory depression
timeFrame: Within 24 hours after the operation
measure: Emergence delirium
timeFrame: Within 24 hours after the operation
measure: Heart rate
timeFrame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
measure: Mean arterial pressure
timeFrame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
measure: The total consumption of opioids during the operation
timeFrame: During procedure
measure: The total consumption of anaesthetic during the operation
timeFrame: During procedure
measure: Incisional related adverse events
timeFrame: Within 1 month after surgery
measure: The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Within 6 month after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.