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Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain

NCT04380298 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-09-09

No results posted yet for this study

Summary

The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical pilot study to compare the efficacy and safety of pre-emptive scalp infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective supratentorial craniotomies.

Conditions

  • Pain
  • Supratentorial Brain Tumor

Interventions

DRUG

Ketorolac

30ml of local infiltration solution containing 60mg ropivacaine

DRUG

Ropivacaine

30ml of local infiltration solution containing 6mg ketorolac

DRUG

Epinephrine

30ml of local infiltration solution containing 0.1mg epinephrine

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-07-31
Completion
2021-08-31

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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 NCT04380298 on ClinicalTrials.gov