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Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Post-craniotomy Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04141319
Recruitment Status : Not yet recruiting
First Posted : October 28, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Fang Luo, Beijing Tiantan Hospital

Brief Summary:
The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical 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

Detailed Description:
The proposed study will be a single-center, prospective, randomized, open-label, blinded-endpoint clinical trial designed to test the hypothesis that the addition of ketorolac to pre-emptive scalp infiltration analgesia can significantly improve analgesia after craniotomies. One hundred participants will be randomized to the ketorolac group or the control group. Patients in the ketorolac group will receive pre-emptive scalp infiltration with opivacaine,ketorolac and epinephrine while patients in the control group will receive pre-emptive scalp infiltration with ropivacaine and epinephrine.The primary outcome measure will be cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS)
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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 scalp infiltration will be performed using 30ml of 60 mg ropivacaine 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




Primary Outcome Measures :
  1. cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively [ Time Frame: 0 to 48 hours postoperatively ]
    The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively


Secondary Outcome Measures :
  1. The time to first request for patient-controlled analgesia butorphanol [ Time Frame: Within 48hours postoperatively ]
    The time to first request for patient-controlled analgesia butorphanol

  2. frequency of pressing patient-controlled analgesia pump [ Time Frame: Within 48hours postoperatively ]
    frequency of patient-controlled analgesia pump

  3. numeral rating scale (NRS) Score [ Time Frame: at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months postoperatively ]
    0 for"no pain" and 10 for "'pain as severe as you can imagine"

  4. Pain control satisfaction score (PCSS) postoperatively [ Time Frame: at 24 hours, 48 hours, 72 hours, 1 week, 1 month, 3 months and 6 months ]
    0 for unsatisfactory and 10 for very satisfactory

  5. Ramsay sedation score (RSS) [ Time Frame: at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours and 72 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 light glabellar 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 light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.


  6. 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 ]
    SpO2

  7. 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 ]
    MAP

  8. 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 ]
    HR

  9. 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 postoperatively ]
    RR

  10. Length of hospital stay [ Time Frame: Length of hospital stay, an arverage of 2 weeks ]
    Length of hospital stay

  11. Wound healing score [ Time Frame: at 3 weeks and 6 weeks after surgery ]
    Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis >3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable

  12. postoperative nausea and vomiting(PONV) [ Time Frame: within 48 hours postoperatively ]
    0, absent; 1, nausea but not requiring treatment; 2, nausea requiring treatment; and 3, vomiting

  13. The presence of respiratory depression [ Time Frame: within 48 hours postoperatively ]
    respiratory rate <10 breaths per minute or SpO2 was<90 %

  14. The incidence of haematoma, wound infection or gastric ulcers [ Time Frame: during hospitalization, within 2 weeks postoperatively ]
    side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141319


Contacts
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Contact: Fang Luo, M.D +8613611326978 13611326978@163.com
Contact: Yitong Jia, M.D +8613811109032 13811109032@163.com

Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Fang Luo, M.D Beijing Tiantan Hospital
Publications:
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Responsible Party: Fang Luo, Director of Department of Pain Management, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04141319    
Other Study ID Numbers: KY-2018-034-02-6
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ketorolac
Epinephrine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents