Pre-emptive Infiltration of the Scalp with Diprospan Plus Ropivacaine for Pain After Craniotomy in Children

NCT ID: NCT06321354

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2024-12-07

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. Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy.

Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.

Conditions

Pain; Postoperative Children

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

The diprospan plus ropivacaine group

Patients in the diprospan plus ropivacaine group will receive a peri-incisional scalp infiltration with 15ml diprospan and 15mg of 1% ropivacaine and normal saline miscible liquids.

Group Type: EXPERIMENTAL

The diprospan plus ropivacaine group

Intervention Type: DRUG

The local infiltration solution containing 0.5ml diprospan and 15mg of 1% ropivacaine. The total volume is 30 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.

The ropivacaine group

Patients in the ropivacaine group will receive a peri-incisional scalp infiltration with 15mg of 1%

Group Type: ACTIVE_COMPARATOR

The ropivacaine group

Intervention Type: DRUG

The local infiltration solution containing 15mg of 1% ropivacaine. The total volume is 30 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.

Interventions

The diprospan plus ropivacaine group

The local infiltration solution containing 0.5ml diprospan and 15mg of 1% ropivacaine. The total volume is 30 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.

Intervention Type: DRUG

The ropivacaine group

The local infiltration solution containing 15mg of 1% ropivacaine. The total volume is 30 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.

Intervention Type: DRUG

Eligibility Criteria

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; 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 must use a patient-controlled analgesia (PCA) device; Children who cannot understand an instruction of pain scales before surgery

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Director of Department of Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luo Fang, M.D

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Ge Ming, M.D

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's hospital affiliated to capital medical university

Locations

Beijing Children's hospital affiliated to capital medical university

Beijing, Beijing Municipality, China

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

KY 2018-066-02-3

Identifier Type: -

Identifier Source: org_study_id