Clinical trial NCT04380298: Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Supratentorial Brain Tumor
Keywords: Pre-emptive Scalp Infiltration
Ketorolac
Postoperative Pain
Supratentorial Craniotomy
A pilot Study
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: cumulative doses of patient-controlled analgesia (PCA) sufentanil consumption
timeFrame: 0 to 48 hours postoperatively
Secondary outcomes:
measure: The time to first request for PCA sufentanil
timeFrame: 0 to 48 hours postoperatively
measure: frequency of pressing PCA pump
timeFrame: Within 48hours postoperatively
measure: numeral rating scale (NRS) Score
timeFrame: at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours postoperatively
measure: Pain control satisfaction score (PCSS) postoperatively
timeFrame: at 24 hours and 48 hours post-operation
measure: Ramsay sedation score (RSS)
timeFrame: at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively
measure: pulse oxygen saturation(SpO2)
timeFrame: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
measure: mean arterial blood pressure(MAP)
timeFrame: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
measure: heart rate(HR)
timeFrame: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
measure: respiratory rate(RR)
timeFrame: 1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postope
measure: Length of hospital stay
timeFrame: Length of hospital stay, an arverage of 2 weeks
measure: postoperative nausea and vomiting(PONV)
timeFrame: within 48 hours postoperatively
measure: The presence of respiratory depression
timeFrame: within 48 hours postoperatively
measure: The incidence of haematoma, wound infection or gastric ulcers
timeFrame: during hospitalization, within 2 weeks postoperatively
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Kerr 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.
citation: Niemelainen 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.
citation: Andersen 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.