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

September 7, 2020 updated by: Fang Luo, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative doses of patient-controlled analgesia (PCA) sufentanil consumption
Time Frame: 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
0 to 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence of respiratory depression
Time Frame: within 48 hours postoperatively
respiratory rate <10 breaths per minute or SpO2 was<90 %
within 48 hours postoperatively
The incidence of haematoma, wound infection or gastric ulcers
Time Frame: during hospitalization, within 2 weeks postoperatively
side effects
during hospitalization, within 2 weeks postoperatively
The time to first request for PCA sufentanil
Time Frame: 0 to 48 hours postoperatively
The time to first request for patient-controlled analgesia
0 to 48 hours postoperatively
frequency of pressing PCA pump
Time Frame: Within 48hours postoperatively
frequency of pressing PCA pump
Within 48hours postoperatively
numeral rating scale (NRS) Score
Time Frame: 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"
at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours postoperatively
Pain control satisfaction score (PCSS) postoperatively
Time Frame: at 24 hours and 48 hours post-operation
0 for unsatisfactory and 10 for very satisfactory
at 24 hours and 48 hours post-operation
Ramsay sedation score (RSS)
Time Frame: 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.
at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively
pulse oxygen saturation(SpO2)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: Length of hospital stay, an arverage of 2 weeks
Length of hospital stay, an arverage of 2 weeks
postoperative nausea and vomiting(PONV)
Time Frame: within 48 hours postoperatively
within 48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2020

Primary Completion (ANTICIPATED)

July 31, 2021

Study Completion (ANTICIPATED)

August 31, 2021

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (ACTUAL)

May 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2018-034-02-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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