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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Supratentorial Brain Tumor

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Ropivacaine
* Drug: Epinephrine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The ketorolac group<br>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. | Drug: Ketorolac<br>* 30ml of local infiltration solution containing 60mg ropivacaine<br>Drug: Ropivacaine<br>* 30ml of local infiltration solution containing 6mg ketorolac<br>Drug: Epinephrine<br>* 30ml of local infiltration solution containing 0.1mg epinephrine<br>|
| Active Comparator: The control group<br>In the control group, preoperative peri-incisional scalpinfiltration will be performed using 30ml of 60 mgropivacaine and 0.1mg epinephrine. | Drug: Ropivacaine<br>* 30ml of local infiltration solution containing 6mg ketorolac<br>Drug: Epinephrine<br>* 30ml of local infiltration solution containing 0.1mg epinephrine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to first request for PCA sufentanil | The time to first request for patient-controlled analgesia | 0 to 48 hours postoperatively | 
| frequency of pressing PCA pump | frequency of pressing PCA pump | Within 48hours postoperatively | 
| numeral rating scale (NRS) Score | 0 forno pain and 10 for pain as severe as you can imagine | at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours postoperatively | 
| Pain control satisfaction score (PCSS) postoperatively | 0 for unsatisfactory and 10 for very satisfactory | at 24 hours and 48 hours post-operation | 
| Ramsay sedation score (RSS) | 1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to lightglabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to lightglabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus. | at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively | 
| pulse oxygen saturation(SpO2) |  | 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 | 
| mean arterial blood pressure(MAP) |  | 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 | 
| heart rate(HR) |  | 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 | 
| respiratory rate(RR) |  | 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 | 
| Length of hospital stay |  | Length of hospital stay, an arverage of 2 weeks | 
| postoperative nausea and vomiting(PONV) |  | within 48 hours postoperatively | 
| The presence of respiratory depression | respiratory rate <10 breaths per minute or SpO2 was<90 % | within 48 hours postoperatively | 
| The incidence of haematoma, wound infection or gastric ulcers | side effects | during hospitalization, within 2 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-emptive Scalp Infiltration, Ketorolac, Postoperative Pain, Supratentorial Craniotomy, A pilot Study