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

Pain, Postoperative Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03636165
• Other study ID #: KY 2018-066-02-1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2021
• Source: Beijing Tiantan Hospital
• Contact: Fang Luo, MD
• Phone: +86 13611326978
• Email: 13611326978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Pain, Postoperative
• Post-Craniotomy Headache

Intervention

Drug:
• Methylprednisolone
The local infiltration solution containing 1.25mg Methylprednisolone per milliliter.
• Ropivacaine
The local infiltration solution containing 2mg Ropivacaine per milliliter.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 24 hours after the operation
Secondary	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.	Within 24 hours after the operation
Secondary	The first time to press the patient-controlled intravenous analgesia button	The first time that the participants press the patient-controlled intravenous analgesia button.	Within 24 hours after the operation
Secondary	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.	Within 24 hours after the operation
Secondary	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 de?ned as a pain score =7.	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
Secondary	Pain control satisfaction score(PCSS)	PCSS (0 for unsatisfactory, and 10 for very satisfied) will be assessed patient satisfaction	At 24 hours,48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
Secondary	length of stay (LOS)	LOS will be recorded as the number of nights spent in hospital after surgery.	At 24 hours,48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months, 6 months after surgery
Secondary	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.	The duration of hospitalization after the operation
Secondary	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	At 2 hours, 4 hours, 8 hours, 24 hours after surgery
Secondary	The time to first water and oral intake request, scales of oral intake after operation		Within 24 hours after the operation
Secondary	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.	Within 24 hours after the operation
Secondary	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.	Within 24 hours after the operation
Secondary	Heart rate		During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
Secondary	Mean arterial pressure		During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
Secondary	The total consumption of opioids during the operation		During procedure
Secondary	The total consumption of anaesthetic during the operation		During procedure
Secondary	Incisional related adverse events	Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.	Within 1 month after surgery
Secondary	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.	Within 6 month after surgery