Clinical trial · Interventional

Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Post-craniotomy Pain

Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS)

NCT04141319CI-TRIAL-00042943unknownPhase 4ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pain	—	UNRESOLVED	—
Supratentorial Brain Tumor	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Epinephrine	Drug	—	UNRESOLVED
Ketorolac	Drug	—	UNRESOLVED
Ropivacaine	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
The ketorolac group
description
Patients 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.
interventionNames
1. Drug: Ketorolac
2. Drug: Ropivacaine
3. Drug: Epinephrine
type
ACTIVE_COMPARATOR
label
The control group
description
In the control group, preoperative peri-incisional scalp infiltration will be performed using 30ml of 60 mg ropivacaine and 0.1mg epinephrine.
interventionNames
1. Drug: Ropivacaine
2. Drug: Epinephrine

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 65 Years

Show eligibility criteria text

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Difficulties in understanding the use of numeral rating scale (NRS) ;
* Patients with suspected intracranial hypertension;
* Pregnant or at breastfeeding;
* Infection at the incisional site；
* History of radiation therapy and chemotherapy preoperatively
* With great likelihood of postoperative radiation therapy and chemotherapy based on preoperative imaging.

References

Publications (4)

BACKGROUNDVacas 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 29285407
BACKGROUNDAndersen 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 23514638
BACKGROUNDSolovyova 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 24196463
BACKGROUNDSong 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 25845547