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Pre-emptive Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Postoperative Pain After Craniotomy

NCT04078139 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2020-11-03

No results posted yet for this study

Summary

Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. However, there has not been reported about local application of methylprednisolone on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Conditions

  • Pain, Postoperative

Interventions

DRUG

The MP/RP group

Miscible liquid of methylprednisolone and ropivacaine in this study will be peri-incisional scalp infiltration with 40mg methylprednisolone, 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated 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 investigator.

DRUG

The RP group

Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated 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 investigator.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Fang Luo, M.D. · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04078139 on ClinicalTrials.gov