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Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache

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ClinicalTrials.gov Identifier: NCT03915639
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Fang Luo, Beijing Tiantan Hospital

Brief Summary:
Postcraniotomy headache (PCH) has been underestimated for the past decades. However, current treatments for PCH are either considered insufficient or accompanied by severe side-effects. Some studies revealed that peri-incisional injection of a mixed cocktail that contains ropivacaine, epinephrine, ketorolac, and methylprednisolone showed significant efficacy in relieving postoperative pain after total hip or knee arthroplasty. Previous literature reported that the cause of PCH was related to incision of the scalp and dura, which is considered similar to causes to postoperative pain after total hip or knee arthroplasty. Thus, investigators suppose that the cocktail mixture can better relieve PCH in adults.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Peri-incisional injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Cocktail
Participants in Group Cocktail are planned to infiltrate the head fixation sites after intubation and peri-incisionally prior to skin incision. The infiltration will be performed by the attending neurosurgeon. The muscle and the subcutaneous tissue beneath the fixation sites and incision site will be fully irrigated with the multimodal cocktail.
Procedure: Peri-incisional injection
The surgeons are planned to inject the cocktail mixture or ropivacaine to muscles and the subcutaneous tissue beneath the fixation sites and incision site using a 22-gauge needle in a sterile fashion prior to skin incision.

Active Comparator: Ropivacaine
Participants in Group Ropivacaine are planned to infiltrate the head fixation sites after intubation and peri-incisionally prior to skin incision. The infiltration will be performed by the attending neurosurgeon. The muscle and the subcutaneous tissue beneath the fixation sites and incision site will be fully irrigated with ropivacaine.
Procedure: Peri-incisional injection
The surgeons are planned to inject the cocktail mixture or ropivacaine to muscles and the subcutaneous tissue beneath the fixation sites and incision site using a 22-gauge needle in a sterile fashion prior to skin incision.




Primary Outcome Measures :
  1. Cumulative morphine consumption [ Time Frame: 24 hours after recovery ]
    cumulative morphine consumption through PCA within 24 hours after recovery


Secondary Outcome Measures :
  1. Postoperative 0-10 Numeric Rating Score [ Time Frame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy ]
    Numeric Rating Score is a common used scale in evaluating patients' pain intensity in clinical trials. The scale in the present trial is ranged from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher values represent worse pain intensity.

  2. Rate of post-operative opioid-related side effects [ Time Frame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery ]

    Post-operative opioid-related side effects include post-operative opioid-induced oversedation, opioid-induced respiratory depression, pruritus, drowsiness, dizziness, blurred vision, and rash.

    Opioid-induced oversedation will be evaluated using the Pasero Opioid-induced Sedation Scale (POSS).

    1. Awake and alert,
    2. Slightly drowsy, easily aroused,
    3. Frequently drowsy, arousable, drift off to sleep during a conversation,
    4. Somnolent, minimal or no response to verbal or physical stimulation A POSS score of 3 or 4 is defined as oversedation.

    Opioid-induced respiratory depression (defined as respiratory rate <8/min and/or oxygen saturation <90% and/or apnoea ≥10 s, excessive sedation or upper airway obstruction.


  3. Time interval to first PCA demand [ Time Frame: within 24 hours after recovery ]
    The PCA device will automatically record the time interval to the first PCA demand based on a specially designed algorithm

  4. Total PCA press counts [ Time Frame: within 24 hours after recovery ]
    The PCA device will automatically record the total press counts based on a specially designed algorithm.

  5. Total rescue medication usage [ Time Frame: within 24 hours after recovery ]
    When PCA is not enough for analgesia, rescue medication will be used for relieving severe pain. The total rescue medication usage within 24 hours after recovery will be recorded.

  6. Recovery [ Time Frame: an average of 1 month ]
    Time to PACU discharge, time to ambulation, and length of stay (LOS)

  7. Wound Healing Score [ Time Frame: 3 and 6 weeks after craniotomy ]

    Wound Healing Score worksheet for assessment of outcomes in scalp clip versus artery forceps groups in patients undergoing craniotomy.

    The wound healing evaluation is based on skin healing, infection and hair regrowth.

    For skin healing, 1 represents fully healed, 2 represents ≤3 cm in total not healed, 3 represents >3 cm not healed, 4 represents areas of necrosis ≤3 cm, and 5 represents areas of necrosis >3 cm.

    For infection, 1 represents none, 2 represents ≤0.5-cm margin of redness , 3 represents more redness or superficial pus, 4 represents deep infection.

    For hair regrowth, 1 represents even regrowth along wound, 2 represents ≤3 cm not regrowing , 3 represents 3-6 cm not regrowing, 4 represents >6 cm not regrowing.

    Excellent wounds, total score of 3; Good wounds, Score 4-5; Suboptimal wounds, Score 6+


  8. The size of surgical incision [ Time Frame: at the end of the craniotomy ]
    Recording the size of surgical incision (unit: centimeter)

  9. The duration of operation [ Time Frame: at the end of the craniotomy ]
    Recording the duration of operation (unit:minute)

  10. Rate of postoperative complications [ Time Frame: within 30 days after craniotomy ]
    Postoperative complications include (1) Operative complications: intracranial infection, cerebral oedema, intracranial haematoma, CSF fistula, reoperation, reintubation and delayed extubation. incision infection, incision haematoma, delayed wound healing; (2) systemic complications: systemic infection, systemic inflammatory response syndrome and sepsis; (3) all-cause mortality

  11. Postoperative antibiotic usage [ Time Frame: within 30 days after craniotomy ]
    postoperative antibiotic usage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Having signed the informed consent,
  2. age 18-80 yrs,
  3. American Society of Anaesthesiologists (ASA) physical status of I or II,
  4. scheduled elective supratentorial craniotomy,
  5. planned head fixation in a skull clamp.

Exclusion Criteria:

  1. Allergy to LAs,
  2. alcohol abuse,
  3. intracranial hypertension,
  4. active psychiatric disorders,
  5. uncontrolled epilepsy,
  6. chronic opioid use (more than 2 weeks),
  7. undergoing a revision craniotomy,
  8. high probability of having postoperative radio- or chemotherapy,
  9. expectation of delayed extubation or no planned extubation,
  10. pregnancy or breastfeeding during the study,
  11. extreme body mass index (BMI) (less than 15 or more than 40),
  12. preoperative Glasgow Coma Scale less than 15,
  13. undergoing emergency or awake craniotomy surgery,
  14. inability to understand the use of the NRS or the PCA. (Patients are informed of the instructions of NRS (from 0 to 10, where 0 and 10 represent no pain and the worst imaginable pain, respectively) and PCA after signing the informed consent the day before the operation. Patients who cannot understand the instruction of NRS and PCA will be excluded from the study.)

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): NCT03915639


Contacts
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Contact: Fang Luo +86 13611326978 13611326978@163.com
Contact: Zheng Chen +86 15010130151 zchan1011@yahoo.com

Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Fang Luo Beijing Tiantan Hospital

Publications:

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Responsible Party: Fang Luo, Director of Department of Pain Management, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03915639     History of Changes
Other Study ID Numbers: KY 2018-035-01
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fang Luo, Beijing Tiantan Hospital:
Post-Craniotomy Headache
Postoperative Pain
Cocktail
Analgesia
Additional relevant MeSH terms:
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Headache
Pain, Postoperative
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents