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

NCT ID: NCT03636165

Last Updated: 2021-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-12-31

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

Conditions

Pain, Postoperative; Post-Craniotomy Headache

Keywords

Postoperative Pain; Post-Craniotomy Headache; Methylprednisolone; Ropivacaine; Pre-emptive Scalp Infiltration; Child

Study Design

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

Study Groups

MP plus RP group

Patients in RP/MP group will receive a peri-incisional scalp infiltration with 0.125% methylprednisolone and 0.2% ropivacaine and normal saline miscible liquids. 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.

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

The local infiltration solution containing 1.25mg Methylprednisolone per milliliter.

Ropivacaine

Intervention Type: DRUG

The local infiltration solution containing 2mg Ropivacaine per milliliter.

RP group

Patients in RP group will receive peri-incisional scalp infiltration with 0.2% ropivacaine alone. 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.

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

The local infiltration solution containing 2mg Ropivacaine per milliliter.

Interventions

Methylprednisolone

The local infiltration solution containing 1.25mg Methylprednisolone per milliliter.

Intervention Type: DRUG

Ropivacaine

The local infiltration solution containing 2mg Ropivacaine per milliliter.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Director of Department of Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fang Luo

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Central Contacts

Fang Luo, MD

Role: CONTACT

Phone: +86 13611326978

Email: 13611326978@163.com

Hao Ren, MD

Role: CONTACT

Phone: +86 18710229893

Email: renh2014@126.com

References

Zhao C, Jia Y, Jia Z, Xiao X, Luo F. Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial. BMJ Open. 2019 Jun 22;9(6):e027864. doi: 10.1136/bmjopen-2018-027864.

Reference Type: DERIVED

PMID: 31230016 (View on PubMed)

Other Identifiers

KY 2018-066-02-1

Identifier Type: -

Identifier Source: org_study_id