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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03636165

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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)

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Cumulative fentanyl consumption within 24 hours postoperatively [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

The number of participants who have no fentanyl consumption [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.
The first time to press the patient-controlled intravenous analgesia button [Within 24 hours after the operation]
The first time that the participants press the patient-controlled intravenous analgesia button.
The total times that participants press patient-controlled intravenous analgesia button [Within 24 hours after the operation]
The total times that participants press patient-controlled intravenous analgesia button including effective presses and ineffective presses.
Numeric Rating Scale (NRS) [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.
Pain control satisfaction score(PCSS) [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
length of stay (LOS) [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.
The occurrence of postoperative nausea and vomiting [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.
Ramsay Sedation Scale（RSS） [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
The time to first water and oral intake request, scales of oral intake after operation [Within 24 hours after the operation]
The occurrence of respiratory depression [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.
Emergence delirium [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.
Heart rate [During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery]
Mean arterial pressure [During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery]
The total consumption of opioids during the operation [During procedure]
The total consumption of anaesthetic during the operation [During procedure]
Incisional related adverse events [Within 1 month after surgery]
Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.
The occurrence of the Adverse events (AEs) and serious adverse events (SAEs) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;
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;
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.