Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain
PAINLESS
1 other identifier
interventional
40
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started Dec 2020
Shorter than P25 for phase_4 pain
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
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedSeptember 9, 2020
September 1, 2020
8 months
May 5, 2020
September 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cumulative doses of patient-controlled analgesia (PCA) sufentanil consumption
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 (13)
The time to first request for PCA sufentanil
0 to 48 hours postoperatively
frequency of pressing PCA pump
Within 48hours postoperatively
numeral rating scale (NRS) Score
at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours postoperatively
Pain control satisfaction score (PCSS) postoperatively
at 24 hours and 48 hours post-operation
Ramsay sedation score (RSS)
at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively
- +8 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 scalpinfiltration will be performed using 30ml of 60 mgropivacaine 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)
Song 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: 25845547BACKGROUNDKerr DR, Kohan L. Local infiltration analgesia: a technique for the control of acute postoperative pain following knee and hip surgery: a case study of 325 patients. Acta Orthop. 2008 Apr;79(2):174-83. doi: 10.1080/17453670710014950.
PMID: 18484242BACKGROUNDNiemelainen M, Kalliovalkama J, Aho AJ, Moilanen T, Eskelinen A. Single periarticular local infiltration analgesia reduces opiate consumption until 48 hours after total knee arthroplasty. A randomized placebo-controlled trial involving 56 patients. Acta Orthop. 2014 Dec;85(6):614-9. doi: 10.3109/17453674.2014.961399. Epub 2014 Sep 19.
PMID: 25238439BACKGROUNDAndersen 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: 23514638BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
May 5, 2020
First Posted
May 8, 2020
Study Start
December 1, 2020
Primary Completion
July 31, 2021
Study Completion
August 31, 2021
Last Updated
September 9, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share