Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Post-craniotomy Pain
NCT04141319 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2020-01-22
Summary
The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical 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
-
30ml of local infiltration solution containing 0.1mg epinephrine
Sponsors & Collaborators
-
Beijing Tiantan Hospital
lead OTHER
Principal Investigators
-
Fang Luo, M.D · Beijing Tiantan Hospital
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
- 2021-12-31
- Primary Completion
- 2022-07-31
- Completion
- 2022-12-31
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