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

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Capital Medical University

Status and phase

Not yet enrolling
Phase 4

Conditions

Post-Craniotomy Headache
Pain, Postoperative

Treatments

Drug: Methylprednisolone
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03636165
KY 2018-066-02-1

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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;
  • 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;
  • Psychiatric disorders;
  • Uncontrolled epilepsy;
  • Chronic headache;
  • Peri-incisional infection;
  • Body mass index exceeded the 99th percentile for age;
  • Children who cannot use patient-controlled intravenous analgesia(PCIA) device;
  • Children who cannot understand an instruction of pain scales before surgery.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups

MP plus RP group
Experimental group
Description:
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.
Treatment:
Drug: Ropivacaine
Drug: Methylprednisolone
RP group
Active Comparator group
Description:
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.
Treatment:
Drug: Ropivacaine

Trial contacts and locations

0

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Central trial contact

Hao Ren, MD; Fang Luo, MD

Data sourced from clinicaltrials.gov

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