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

Phase 4

• Conditions: Pain; Supratentorial Brain Tumor
• Interventions: Drug: Ropivacaine; Drug: Ketorolac; Drug: Epinephrine

• Registration Number: NCT04380298
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09
• Study Start: 2020-12-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The ketorolac group	Epinephrine	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.
The control group	Ropivacaine	In the control group, preoperative peri-incisional scalpinfiltration will be performed using 30ml of 60 mgropivacaine and 0.1mg epinephrine.
The control group	Epinephrine	In the control group, preoperative peri-incisional scalpinfiltration will be performed using 30ml of 60 mgropivacaine and 0.1mg epinephrine.
The ketorolac group	Ketorolac	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.
The ketorolac group	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
cumulative doses of patient-controlled analgesia (PCA) sufentanil consumption	0 to 48 hours postoperatively	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

Secondary Outcome Measures

Name	Time	Method
The time to first request for PCA sufentanil	0 to 48 hours postoperatively	The time to first request for patient-controlled analgesia
frequency of pressing PCA pump	Within 48hours postoperatively	frequency of pressing PCA pump
postoperative nausea and vomiting(PONV)	within 48 hours postoperatively
The incidence of haematoma, wound infection or gastric ulcers	during hospitalization, within 2 weeks postoperatively	side effects
Pain control satisfaction score (PCSS) postoperatively	at 24 hours and 48 hours post-operation	0 for unsatisfactory and 10 for very satisfactory
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
Length of hospital stay	Length of hospital stay, an arverage of 2 weeks
numeral rating scale (NRS) Score	at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours postoperatively	0 for"no pain" and 10 for "pain as severe as you can imagine"
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
Ramsay sedation score (RSS)	at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively	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.
The presence of respiratory depression	within 48 hours postoperatively	respiratory rate \<10 breaths per minute or SpO2 was\<90 %