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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04380298

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Supratentorial Brain Tumor	Drug: Ketorolac Drug: Ropivacaine Drug: Epinephrine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Aug 31, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: The ketorolac group

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

30ml of local infiltration solution containing 60mg ropivacaine

Drug: Ropivacaine

30ml of local infiltration solution containing 6mg ketorolac

Drug: Epinephrine

30ml of local infiltration solution containing 0.1mg epinephrine

Active Comparator: The control group

In the control group, preoperative peri-incisional scalpinfiltration will be performed using 30ml of 60 mgropivacaine and 0.1mg epinephrine.

Drug: Ropivacaine

30ml of local infiltration solution containing 6mg ketorolac

Drug: Epinephrine

30ml of local infiltration solution containing 0.1mg epinephrine

Outcome Measures

Primary Outcome Measures

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

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
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"
Pain control satisfaction score (PCSS) postoperatively [at 24 hours and 48 hours post-operation]
0 for unsatisfactory and 10 for very satisfactory
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.
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 [within 48 hours postoperatively]
respiratory rate <10 breaths per minute or SpO2 was<90 %
The incidence of haematoma, wound infection or gastric ulcers [during hospitalization, within 2 weeks postoperatively]
side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.