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Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache

NCT03915639 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-05-27

No results posted yet for this study

Summary

Postcraniotomy headache (PCH) has been underestimated for the past decades. However, current treatments for PCH are either considered insufficient or accompanied by severe side-effects. Some studies revealed that peri-incisional injection of a mixed cocktail that contains ropivacaine, epinephrine, ketorolac, and methylprednisolone showed significant efficacy in relieving postoperative pain after total hip or knee arthroplasty. Previous literature reported that the cause of PCH was related to incision of the scalp and dura, which is considered similar to causes to postoperative pain after total hip or knee arthroplasty. Thus, investigators suppose that the cocktail mixture can better relieve PCH in adults.

Conditions

  • Pain, Postoperative

Interventions

PROCEDURE

Peri-incisional injection

The surgeons are planned to inject the cocktail mixture or ropivacaine to muscles and the subcutaneous tissue beneath the fixation sites and incision site using a 22-gauge needle in a sterile fashion prior to skin incision.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Fang Luo · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2023-06-30
Completion
2023-12-31

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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 NCT03915639 on ClinicalTrials.gov