Pre-emptive Scalp Infiltration with Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children

NCT06779396 | Recruiting Phase 4 DMC

• 1 other identifier: KY 2018-066-02-4
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.However, there has not been reported about local application of triamcinolone acetonide on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (triamcinolone acetonide) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.

Conditions

Pain; Postoperative Children

Keywords

Postoperative Pain; Pre-emptive Scalp Infiltration; Triamcinolone Acetonide

Outcome Measures

Primary Outcomes (1)

• the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

  Postoperative pain will be estimated by usingthe Faces, Legs, Activity, Cry, Consolability (FLACC) scale score at 24 hours postoperatively.

  At 24 hours after the operation

Secondary Outcomes (7)

• the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

  At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery

• Duration of analgesia

  Within 48 hours after the operation

• The occurrence of postoperative nausea and vomiting (PONV)

  At 2 hours, 4 hours, 8 hours, 24 hours after surgery

• Incisional related adverse events

  Approximately 1 weeks after the operation

• The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)

  Within 1 weeks after the operation

Study Arms (2)

Experimental: The triamcinolone acetonide plus ropivacaine group

EXPERIMENTAL

Patients in the triamcinolone acetonide plus ropivacaine group will receive a peri-incisional scalp infiltration with 0.2% ropivacaine(40mg) and 4 mg of triamcinolone acetonide and normal saline miscible liquids.

Drug: The triamcinolone acetonide plus ropivacaine group

Active Comparator: The ropivacaine group

ACTIVE COMPARATOR

Patients in the ropivacaine group will receive a peri-incisional scalp infiltration 0.2% ropivacaine(40mg)

Drug: The ropivacaine group

Interventions

The triamcinolone acetonide plus ropivacaine group DRUG

The solution prepared comprised a mixture of 20mL of 0.2% ropivacaine(40mg) with 4 mg of triamcinolone acetonide. 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.

Experimental: The triamcinolone acetonide plus ropivacaine group

The ropivacaine group DRUG

The local infiltration solution containing 20mg of 1% ropivacaine. The total volume is 20 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

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (1) Age 2 to 12 years. (2) American Society of Anesthesiologists (ASA) physical status I or II. (3)Participates with an anticipated fully recovery within 2 hours postoperatively.
• (4)Informed consent by parent(s) and/or legal guardian.

You may not qualify if:

• \- (1) Allergy to local anesthetics. (2) Pediatric patients aged\>12 or \<2 years. (3) Under medication with analgesic drugs. (4) Psychiatric disorders. (5) Uncontrolled epilepsy. (6) Chronic headache. (7) Peri-incisional infection. (8) Coagulopathy or bleeding disorder. (9) Patients who are expected to remain intubated and mechanical ventilation after surgery.
• (10) Emergency craniotomies. (11) Patients with cardiac insufficiency or severe kidney or liver diseases. (12) Patients whose authorized surrogates are unwilling to participate in the study

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Fang Luo

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Luo

CONTACT

+86 13611326978; 13611326978@163.com

Qiang Liu

CONTACT

+86 15811023611; liuqiangcg@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: January 10, 2025
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)