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

Phase 4RecruitingNCT06779396

Beijing Tiantan Hospital128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

128

Conditions

Pain

Interventions

The triamcinolone acetonide plus ropivacaine groupDRUG

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.

The ropivacaine groupDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: -(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. Exclusion Criteria: \- (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

Outcomes

Primary Outcomes

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.

Time frame: At 24 hours after the operation

Secondary Outcomes

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

Postoperative pain will be estimated by using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

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

Duration of analgesia

the time to the first postoperative analgesic request

Time frame: Within 48 hours after the operation

The occurrence of postoperative nausea and vomiting (PONV)

PONV will be rated by participants as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.

Time frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery

Incisional related adverse events

Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.

Time frame: Approximately 1 weeks after the operation

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.

Time frame: Within 1 weeks after the operation

Patient satisfactory scale (PSS)

0 for unsatisfactory, and 10 for very satisfied

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

The total consumption of opioids during the operation

Time frame: During procedure