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Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FA plus ropivacaine
ropivacaine alone
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age minimum 18 years; ASA physical status of I - II; Body mass index (BMI) of 15 - 30; Scheduled for supratentorial craniotomy under general anesthesia; Anticipated tracheal extubation, recovery of consciousness and orientation within 2 hours after craniotomy. Exclusion Criteria: Glasgow Coma Scale <15; Unable to use the PCIA device or comprehend the pain NRS; History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery; History of craniotomy or scalp infection; Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease; History of allergy to any drug used in the study; Pregnancy and breastfeeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ropivacaine plus FA

    ropivacaine alone

    Arm Description

    5 mL FA (50 mg; by Beijing Taide Pharmaceutical Co., Ltd) and 15 mL of 1% ropivacaine (Nai Le Pin 10mg/mL; by AstraZeneca AB, Sweden) diluted to a total volume of 30 mL in normal saline

    15 mL of 1% ropivacaine diluted to a total volume of 30 mL in normal saline

    Outcomes

    Primary Outcome Measures

    Total consumption of sufentanil with PCIA device at 48 hours postoperatively.
    A postoperative Patient Controlled Intravenous Analgesia (PCIA) pump containing sufentanil 200μg in 100 mL saline will be administered from admission to the PACU until postoperative 48 hours. The PCIA pump will be set for 0.5 mL bolus doses with a lockout time of 15 min without initial dose or continuous infusion. The maximum dose will be limited to 2 mL (sufentanil 4 μg) per hour.

    Secondary Outcome Measures

    Total consumption of sufentanil with PCIA pump at 24 hours after craniotomy
    A postoperative Patient Controlled Intravenous Analgesia (PCIA) pump containing sufentanil 200μg in 100 mL saline will be administered from admission to the PACU until postoperative 48 hours. The PCIA pump will be set for 0.5 mL bolus doses with a lockout time of 15 min without initial dose or continuous infusion. The maximum dose will be limited to 2 mL (sufentanil 4 μg) per hour.
    Time to first PCIA button press after craniotomy
    A postoperative Patient Controlled Intravenous Analgesia (PCIA) pump containing sufentanil 200μg in 100 mL saline will be administered from admission to the PACU until postoperative 48 hours. The PCIA pump will be set for 0.5 mL bolus doses with a lockout time of 15 min without initial dose or continuous infusion. The maximum dose will be limited to 2 mL (sufentanil 4 μg) per hour.
    Pain NRS scores at 2 hours after craniotomy
    0 indicates no pain and 10 indicates the worst pain imaginable
    Pain NRS scores at 4 hours after craniotomy
    0 indicates no pain and 10 indicates the worst pain imaginable
    Pain NRS scores at 12 hours after craniotomy
    0 indicates no pain and 10 indicates the worst pain imaginable
    Pain NRS scores at 24 hours after craniotomy
    0 indicates no pain and 10 indicates the worst pain imaginable
    Pain NRS scores at 48 hours after craniotomy
    0 indicates no pain and 10 indicates the worst pain imaginable
    Pain NRS scores at 1 mon after craniotomy
    0 indicates no pain and 10 indicates the worst pain imaginable
    Pain NRS scores at 3 mons after craniotomy
    0 indicates no pain and 10 indicates the worst pain imaginable
    The time to first prescription of OC/APAP after craniotomy
    In the ward, if a patient scores > 4 in pain NRS after receiving a maximum dose of 2 mL per hour from PCIA device, an oral supplementary tablet of oxycodone (OC)/acetaminophen (APAP) (5/325 mg; by MallinckrodtInc, USA) will be prescribed as a rescue analgesic at an interval of at least 6 hours.
    Hospital duration after craniotomy
    The duration from end of surgery to discharge from hospital
    WHOQOL-BREF score
    It is a questionnaire consisting of social relationships, physical health, psychological health, environment, overall QoL and general health. The mean score of each domain ranges between 4 and 20. A higher score indicates a better QoL
    WHOQOL-BREF score
    It is a questionnaire consisting of social relationships, physical health, psychological health, environment, overall QoL and general health. The mean score of each domain ranges between 4 and 20. A higher score indicates a better QoL
    PONV scores
    It is rated as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting
    PONV scores
    It is rated as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting
    Wound healing score
    It is rated as excellent, good and suboptimal
    Wound healing score
    It is rated as excellent, good and suboptimal
    Patient and Observer Scar Assessment Scale
    It consists of 2 numeric scales regarding the observer component (6 items) and the patient component (6 items). All included items are scored on the same 10-point scale. And a higher score represents a poorer scar quality.
    Patient and Observer Scar Assessment Scale
    It consists of 2 numeric scales regarding the observer component (6 items) and the patient component (6 items). All included items are scored on the same 10-point scale. And a higher score represents a poorer scar quality.
    The occurrence of other AEs
    Other AEs include cerebral hematoma, respiratory depression, gastrointestinal ulcerations and perforation, renal risks, coagulation dysfunction, allergic reaction and wound infection, oozing, hemorrhage, burning sensation and mild pruritus

    Full Information

    First Posted
    November 7, 2022
    Last Updated
    April 6, 2023
    Sponsor
    Beijing Tiantan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05624359
    Brief Title
    Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration
    Official Title
    Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration for Post-craniotomy Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (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

    5. Study Description

    Brief Summary
    Post-craniotomy pain remains a major challenge in patient care following neurosurgery.Flurbiprofen axetil (FA), as an injectable nonselective cyclooxygenase inhibitor, is a widely prescribed NSAID for postoperative pain. As FA is highly lipophilic by merging into emulsified lipid microspheres, it has a high affinity to the surgical incision and inflammatory tissues to achieve targeted drug therapy and prolonged duration of action, thus providing a basis for its local use to achieve efficacy and safety comparable to or greater than systemic administration. In this study, we attempt to evaluate the clinical effects of FA as an adjunct to ropivacaine in pre-emptive scalp infiltration to prevent or reduce pain after craniotomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    216 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ropivacaine plus FA
    Arm Type
    Experimental
    Arm Description
    5 mL FA (50 mg; by Beijing Taide Pharmaceutical Co., Ltd) and 15 mL of 1% ropivacaine (Nai Le Pin 10mg/mL; by AstraZeneca AB, Sweden) diluted to a total volume of 30 mL in normal saline
    Arm Title
    ropivacaine alone
    Arm Type
    Active Comparator
    Arm Description
    15 mL of 1% ropivacaine diluted to a total volume of 30 mL in normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    FA plus ropivacaine
    Intervention Description
    Th group will receive 0.17% FA and 0.5% ropivacaine for pre-emptive scalp infiltration at about 30 min before surgical incision. The assigned solution was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder, using a 22-gauge needle introduced throughout the entire thickness of the scalp at a 45° angle.
    Intervention Type
    Drug
    Intervention Name(s)
    ropivacaine alone
    Intervention Description
    The ropivacaine alone group will receive 0.5% ropivacaine alone for pre-emptive scalp infiltration at about 30 min before surgical incision. The assigned solution was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder, using a 22-gauge needle introduced throughout the entire thickness of the scalp at a 45° angle.
    Primary Outcome Measure Information:
    Title
    Total consumption of sufentanil with PCIA device at 48 hours postoperatively.
    Description
    A postoperative Patient Controlled Intravenous Analgesia (PCIA) pump containing sufentanil 200μg in 100 mL saline will be administered from admission to the PACU until postoperative 48 hours. The PCIA pump will be set for 0.5 mL bolus doses with a lockout time of 15 min without initial dose or continuous infusion. The maximum dose will be limited to 2 mL (sufentanil 4 μg) per hour.
    Time Frame
    at 48 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Total consumption of sufentanil with PCIA pump at 24 hours after craniotomy
    Description
    A postoperative Patient Controlled Intravenous Analgesia (PCIA) pump containing sufentanil 200μg in 100 mL saline will be administered from admission to the PACU until postoperative 48 hours. The PCIA pump will be set for 0.5 mL bolus doses with a lockout time of 15 min without initial dose or continuous infusion. The maximum dose will be limited to 2 mL (sufentanil 4 μg) per hour.
    Time Frame
    at 24 hours postoperatively
    Title
    Time to first PCIA button press after craniotomy
    Description
    A postoperative Patient Controlled Intravenous Analgesia (PCIA) pump containing sufentanil 200μg in 100 mL saline will be administered from admission to the PACU until postoperative 48 hours. The PCIA pump will be set for 0.5 mL bolus doses with a lockout time of 15 min without initial dose or continuous infusion. The maximum dose will be limited to 2 mL (sufentanil 4 μg) per hour.
    Time Frame
    after craniotomy
    Title
    Pain NRS scores at 2 hours after craniotomy
    Description
    0 indicates no pain and 10 indicates the worst pain imaginable
    Time Frame
    at 2 hours after craniotomy
    Title
    Pain NRS scores at 4 hours after craniotomy
    Description
    0 indicates no pain and 10 indicates the worst pain imaginable
    Time Frame
    at 4 hours after craniotomy
    Title
    Pain NRS scores at 12 hours after craniotomy
    Description
    0 indicates no pain and 10 indicates the worst pain imaginable
    Time Frame
    at 12 hours after craniotomy
    Title
    Pain NRS scores at 24 hours after craniotomy
    Description
    0 indicates no pain and 10 indicates the worst pain imaginable
    Time Frame
    at 24 hours after craniotomy
    Title
    Pain NRS scores at 48 hours after craniotomy
    Description
    0 indicates no pain and 10 indicates the worst pain imaginable
    Time Frame
    at 48 hours after craniotomy
    Title
    Pain NRS scores at 1 mon after craniotomy
    Description
    0 indicates no pain and 10 indicates the worst pain imaginable
    Time Frame
    at 1 mon after craniotomy
    Title
    Pain NRS scores at 3 mons after craniotomy
    Description
    0 indicates no pain and 10 indicates the worst pain imaginable
    Time Frame
    at 3 mons after craniotomy
    Title
    The time to first prescription of OC/APAP after craniotomy
    Description
    In the ward, if a patient scores > 4 in pain NRS after receiving a maximum dose of 2 mL per hour from PCIA device, an oral supplementary tablet of oxycodone (OC)/acetaminophen (APAP) (5/325 mg; by MallinckrodtInc, USA) will be prescribed as a rescue analgesic at an interval of at least 6 hours.
    Time Frame
    up to 48 hours after craniotmy
    Title
    Hospital duration after craniotomy
    Description
    The duration from end of surgery to discharge from hospital
    Time Frame
    From surgery day until the discharge date from hospital, assessed up to one week
    Title
    WHOQOL-BREF score
    Description
    It is a questionnaire consisting of social relationships, physical health, psychological health, environment, overall QoL and general health. The mean score of each domain ranges between 4 and 20. A higher score indicates a better QoL
    Time Frame
    at 1month after craniotomy
    Title
    WHOQOL-BREF score
    Description
    It is a questionnaire consisting of social relationships, physical health, psychological health, environment, overall QoL and general health. The mean score of each domain ranges between 4 and 20. A higher score indicates a better QoL
    Time Frame
    at 3 months after craniotomy
    Title
    PONV scores
    Description
    It is rated as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting
    Time Frame
    at 24 hours after surgery
    Title
    PONV scores
    Description
    It is rated as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting
    Time Frame
    at 48 hours after surgery
    Title
    Wound healing score
    Description
    It is rated as excellent, good and suboptimal
    Time Frame
    at 1 month after craniotomy
    Title
    Wound healing score
    Description
    It is rated as excellent, good and suboptimal
    Time Frame
    at 3 months after craniotomy
    Title
    Patient and Observer Scar Assessment Scale
    Description
    It consists of 2 numeric scales regarding the observer component (6 items) and the patient component (6 items). All included items are scored on the same 10-point scale. And a higher score represents a poorer scar quality.
    Time Frame
    at 1 month after craniotomy
    Title
    Patient and Observer Scar Assessment Scale
    Description
    It consists of 2 numeric scales regarding the observer component (6 items) and the patient component (6 items). All included items are scored on the same 10-point scale. And a higher score represents a poorer scar quality.
    Time Frame
    at 3 months after craniotomy
    Title
    The occurrence of other AEs
    Description
    Other AEs include cerebral hematoma, respiratory depression, gastrointestinal ulcerations and perforation, renal risks, coagulation dysfunction, allergic reaction and wound infection, oozing, hemorrhage, burning sensation and mild pruritus
    Time Frame
    throughout both the treatment and follow-up periods (up to 3 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age minimum 18 years; ASA physical status of I - II; Body mass index (BMI) of 15 - 30; Scheduled for supratentorial craniotomy under general anesthesia; Anticipated tracheal extubation, recovery of consciousness and orientation within 2 hours after craniotomy. Exclusion Criteria: Glasgow Coma Scale <15; Unable to use the PCIA device or comprehend the pain NRS; History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery; History of craniotomy or scalp infection; Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease; History of allergy to any drug used in the study; Pregnancy and breastfeeding.

    12. IPD Sharing Statement

    Learn more about this trial

    Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration

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