CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 100 target
Drug / intervention
Peri-incisional injectionprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03915639
NCT03915639N/AUnknown

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

Beijing Tiantan Hospital·interventional·Posted Apr 16, 2019·Updated May 27, 2020

In Brief

A clinical study evaluating Peri-incisional injection for Pain, Postoperative. Targeting 100 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/AUnknownOverdue
2020202120222023202420252026
First PostedApr 16, 2019
Enrollment StartApr 1, 2022
Primary CompletionJun 1, 2023
Study CompletionDec 1, 2023
TodayJul 1, 2026
Enrollment to primary: 1.2 yearsPosted 7.2 years ago

Interventions

Peri-incisional injectionprocedure

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.