search
Back to results

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

Primary Purpose

Pain, Supratentorial Brain Tumor

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketorolac
Ropivacaine
Epinephrine
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    The ketorolac group

    The control group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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 patient-controlled analgesia butorphanol
    The time to first request for patient-controlled analgesia butorphanol
    frequency of pressing patient-controlled analgesia pump
    frequency of patient-controlled analgesia pump
    numeral rating scale (NRS) Score
    0 for"no pain" and 10 for "'pain as severe as you can imagine"
    Pain control satisfaction score (PCSS) postoperatively
    0 for unsatisfactory and 10 for very satisfactory
    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 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.
    pulse oxygen saturation(SpO2)
    SpO2
    mean arterial blood pressure(MAP)
    MAP
    heart rate(HR)
    HR
    respiratory rate(RR)
    RR
    Length of hospital stay
    Length of hospital stay
    Wound healing score
    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
    postoperative nausea and vomiting(PONV)
    0, absent; 1, nausea but not requiring treatment; 2, nausea requiring treatment; and 3, vomiting
    The presence of respiratory depression
    respiratory rate <10 breaths per minute or SpO2 was<90 %
    The incidence of haematoma, wound infection or gastric ulcers
    side effects

    Full Information

    First Posted
    October 20, 2019
    Last Updated
    January 21, 2020
    Sponsor
    Beijing Tiantan Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04141319
    Brief Title
    Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Post-craniotomy Pain
    Official Title
    Effects of Pre-emptive Scalp Infiltration With Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Tiantan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Supratentorial Brain Tumor

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The ketorolac group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    The control group
    Arm Type
    Active Comparator
    Arm Description
    In the control group, preoperative peri-incisional scalp infiltration will be performed using 30ml of 60 mg ropivacaine and 0.1mg epinephrine.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketorolac
    Intervention Description
    30ml of local infiltration solution containing 60mg ropivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Intervention Description
    30ml of local infiltration solution containing 6mg ketorolac
    Intervention Type
    Drug
    Intervention Name(s)
    Epinephrine
    Intervention Description
    30ml of local infiltration solution containing 0.1mg epinephrine
    Primary Outcome Measure Information:
    Title
    cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively
    Description
    The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively
    Time Frame
    0 to 48 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    The time to first request for patient-controlled analgesia butorphanol
    Description
    The time to first request for patient-controlled analgesia butorphanol
    Time Frame
    Within 48hours postoperatively
    Title
    frequency of pressing patient-controlled analgesia pump
    Description
    frequency of patient-controlled analgesia pump
    Time Frame
    Within 48hours postoperatively
    Title
    numeral rating scale (NRS) Score
    Description
    0 for"no pain" and 10 for "'pain as severe as you can imagine"
    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
    Title
    Pain control satisfaction score (PCSS) postoperatively
    Description
    0 for unsatisfactory and 10 for very satisfactory
    Time Frame
    at 24 hours, 48 hours, 72 hours, 1 week, 1 month, 3 months and 6 months
    Title
    Ramsay sedation score (RSS)
    Description
    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.
    Time Frame
    at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours and 72 hours postoperatively
    Title
    pulse oxygen saturation(SpO2)
    Description
    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
    Title
    mean arterial blood pressure(MAP)
    Description
    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
    Title
    heart rate(HR)
    Description
    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
    Title
    respiratory rate(RR)
    Description
    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
    Title
    Length of hospital stay
    Description
    Length of hospital stay
    Time Frame
    Length of hospital stay, an arverage of 2 weeks
    Title
    Wound healing score
    Description
    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
    Time Frame
    at 3 weeks and 6 weeks after surgery
    Title
    postoperative nausea and vomiting(PONV)
    Description
    0, absent; 1, nausea but not requiring treatment; 2, nausea requiring treatment; and 3, vomiting
    Time Frame
    within 48 hours postoperatively
    Title
    The presence of respiratory depression
    Description
    respiratory rate <10 breaths per minute or SpO2 was<90 %
    Time Frame
    within 48 hours postoperatively
    Title
    The incidence of haematoma, wound infection or gastric ulcers
    Description
    side effects
    Time Frame
    during hospitalization, within 2 weeks postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang Luo, M.D
    Phone
    +8613611326978
    Email
    13611326978@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yitong Jia, M.D
    Phone
    +8613811109032
    Email
    13811109032@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fang Luo, M.D
    Organizational Affiliation
    Beijing Tiantan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    29285407
    Citation
    Vacas S, Van de Wiele B. Designing a pain management protocol for craniotomy: A narrative review and consideration of promising practices. Surg Neurol Int. 2017 Dec 6;8:291. doi: 10.4103/sni.sni_301_17. eCollection 2017.
    Results Reference
    background
    PubMed Identifier
    23514638
    Citation
    Andersen KV, Nikolajsen L, Haraldsted V, Odgaard A, Soballe K. Local infiltration analgesia for total knee arthroplasty: should ketorolac be added? Br J Anaesth. 2013 Aug;111(2):242-8. doi: 10.1093/bja/aet030. Epub 2013 Mar 20.
    Results Reference
    background
    PubMed Identifier
    24196463
    Citation
    Solovyova O, Lewis CG, Abrams JH, Grady-Benson J, Joyce ME, Schutzer SF, Arumugam S, Caminiti S, Sinha SK. Local infiltration analgesia followed by continuous infusion of local anesthetic solution for total hip arthroplasty: a prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 2013 Nov 6;95(21):1935-41. doi: 10.2106/JBJS.L.00477.
    Results Reference
    background
    PubMed Identifier
    25845547
    Citation
    Song J, Li L, Yu P, Gao T, Liu K. Preemptive scalp infiltration with 0.5% ropivacaine and 1% lidocaine reduces postoperative pain after craniotomy. Acta Neurochir (Wien). 2015 Jun;157(6):993-8. doi: 10.1007/s00701-015-2394-8. Epub 2015 Apr 7.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs