Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Post-craniotomy Pain
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Dec 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 22, 2020
January 1, 2020
7 months
October 20, 2019
January 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively
The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively
0 to 48 hours postoperatively
Secondary Outcomes (14)
The time to first request for patient-controlled analgesia butorphanol
Within 48hours postoperatively
frequency of pressing patient-controlled analgesia pump
Within 48hours postoperatively
numeral rating scale (NRS) Score
at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months postoperatively
Pain control satisfaction score (PCSS) postoperatively
at 24 hours, 48 hours, 72 hours, 1 week, 1 month, 3 months and 6 months
Ramsay sedation score (RSS)
at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours and 72 hours postoperatively
- +9 more secondary outcomes
Study Arms (2)
The ketorolac group
EXPERIMENTALPatients assigned to the ketorolac group will receive pre-emptive scalp infiltration with 30ml of local infiltration solution containing 60 mg ropivacaine, 6 mg ketorolac and 0.1mg epinephrine.
The control group
ACTIVE COMPARATORIn the control group, preoperative peri-incisional scalp infiltration will be performed using 30ml of 60 mg ropivacaine and 0.1mg epinephrine.
Interventions
30ml of local infiltration solution containing 6mg ketorolac
30ml of local infiltration solution containing 0.1mg epinephrine
Eligibility Criteria
You may qualify if:
- Scheduled for elective supratentorial tumour resection;
- Planned general anaesthesia;
- American Society of Anesthesiologists (ASA) physical status I - II;
- Age ranging from 18 to 65 years old;
- Participates required to fix their head in a head clamp intraoperatively;
- Participates with an anticipated awake within 2 hours after surgery.
You may not qualify if:
- Allergy/intolerance to study drugs including anesthetic drugs, ketorolac and epinephrine;
- Expected delayed extubation or no plan to extubate;
- History of neurosurgeries;
- Long-term use of analgesics and sedatives (more than 2 weeks)
- Receiving any painkiller within 24 h before the operation;
- Extreme body mass index (BMI) (less than 15 or more than 35);
- Patients with impaired cardiopulmonary;
- Patients with impaired renal function;
- Patients with impaired hepatic function;
- History of chronic headache;
- Patients with cognitive deficit;
- Patients with intellectual disability;
- Patients with uncontrolled epilepsy;
- Patients with psychiatric disorders;
- Difficulties in using PCA device
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Vacas S, Van de Wiele B. Designing a pain management protocol for craniotomy: A narrative review and consideration of promising practices. Surg Neurol Int. 2017 Dec 6;8:291. doi: 10.4103/sni.sni_301_17. eCollection 2017.
PMID: 29285407BACKGROUNDAndersen KV, Nikolajsen L, Haraldsted V, Odgaard A, Soballe K. Local infiltration analgesia for total knee arthroplasty: should ketorolac be added? Br J Anaesth. 2013 Aug;111(2):242-8. doi: 10.1093/bja/aet030. Epub 2013 Mar 20.
PMID: 23514638BACKGROUNDSolovyova O, Lewis CG, Abrams JH, Grady-Benson J, Joyce ME, Schutzer SF, Arumugam S, Caminiti S, Sinha SK. Local infiltration analgesia followed by continuous infusion of local anesthetic solution for total hip arthroplasty: a prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 2013 Nov 6;95(21):1935-41. doi: 10.2106/JBJS.L.00477.
PMID: 24196463BACKGROUNDSong J, Li L, Yu P, Gao T, Liu K. Preemptive scalp infiltration with 0.5% ropivacaine and 1% lidocaine reduces postoperative pain after craniotomy. Acta Neurochir (Wien). 2015 Jun;157(6):993-8. doi: 10.1007/s00701-015-2394-8. Epub 2015 Apr 7.
PMID: 25845547BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fang Luo, M.D
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Pain Management
Study Record Dates
First Submitted
October 20, 2019
First Posted
October 28, 2019
Study Start
December 1, 2021
Primary Completion
July 1, 2022
Study Completion
December 1, 2022
Last Updated
January 22, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share