NCT04380298

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

Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS): a Randomized Controlled Pilot Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-07-31
• Completion: 2021-08-31
• First posted: 2020-05-08
• Last updated: 2020-09-09