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NCT Number: NCT06779396

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

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.

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: At 24 hours after the operation

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

Secondary outcomes

  1. 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

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

  2. Duration of analgesia

    Time frame: Within 48 hours after the operation

    the time to the first postoperative analgesic request

  3. The occurrence of postoperative nausea and vomiting (PONV)

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

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

  4. Incisional related adverse events

    Time frame: Approximately 1 weeks after the operation

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

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

    Time frame: Within 1 weeks after the operation

    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.

  6. Patient satisfactory scale (PSS)

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

    0 for unsatisfactory, and 10 for very satisfied

  7. The total consumption of opioids during the operation

    Time frame: During procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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