Back to resultsEffect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
Primary Purpose
Pain, Postoperative
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peri-incisional injection
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Post-Craniotomy Headache, Postoperative Pain, Cocktail, Analgesia
Eligibility Criteria
Inclusion Criteria:
- Having signed the informed consent,
- age 18-80 yrs,
- American Society of Anaesthesiologists (ASA) physical status of I or II,
- scheduled elective supratentorial craniotomy,
- planned head fixation in a skull clamp.
Exclusion Criteria:
- Allergy to LAs,
- alcohol abuse,
- intracranial hypertension,
- active psychiatric disorders,
- uncontrolled epilepsy,
- chronic opioid use (more than 2 weeks),
- undergoing a revision craniotomy,
- high probability of having postoperative radio- or chemotherapy,
- expectation of delayed extubation or no planned extubation,
- pregnancy or breastfeeding during the study,
- extreme body mass index (BMI) (less than 15 or more than 40),
- preoperative Glasgow Coma Scale less than 15,
- undergoing emergency or awake craniotomy surgery,
- 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.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cocktail
Ropivacaine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Cumulative morphine consumption
cumulative morphine consumption through PCA within 24 hours after recovery
Secondary Outcome Measures
Postoperative 0-10 Numeric Rating Score
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.
Rate of post-operative opioid-related side effects
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).
Awake and alert,
Slightly drowsy, easily aroused,
Frequently drowsy, arousable, drift off to sleep during a conversation,
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.
Time interval to first PCA demand
The PCA device will automatically record the time interval to the first PCA demand based on a specially designed algorithm
Total PCA press counts
The PCA device will automatically record the total press counts based on a specially designed algorithm.
Total rescue medication usage
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.
Recovery
Time to PACU discharge, time to ambulation, and length of stay (LOS)
Wound Healing Score
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+
The size of surgical incision
Recording the size of surgical incision (unit: centimeter)
The duration of operation
Recording the duration of operation (unit:minute)
Rate of postoperative complications
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
Postoperative antibiotic usage
postoperative antibiotic usage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03915639
Brief Title
Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
Official Title
Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Post-Craniotomy Headache, Postoperative Pain, Cocktail, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cocktail
Arm Type
Experimental
Arm Description
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.
Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Peri-incisional injection
Intervention Description
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 Measure Information:
Title
Cumulative morphine consumption
Description
cumulative morphine consumption through PCA within 24 hours after recovery
Time Frame
24 hours after recovery
Secondary Outcome Measure Information:
Title
Postoperative 0-10 Numeric Rating Score
Description
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.
Time Frame
1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy
Title
Rate of post-operative opioid-related side effects
Description
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).
Awake and alert,
Slightly drowsy, easily aroused,
Frequently drowsy, arousable, drift off to sleep during a conversation,
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.
Time Frame
1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery
Title
Time interval to first PCA demand
Description
The PCA device will automatically record the time interval to the first PCA demand based on a specially designed algorithm
Time Frame
within 24 hours after recovery
Title
Total PCA press counts
Description
The PCA device will automatically record the total press counts based on a specially designed algorithm.
Time Frame
within 24 hours after recovery
Title
Total rescue medication usage
Description
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.
Time Frame
within 24 hours after recovery
Title
Recovery
Description
Time to PACU discharge, time to ambulation, and length of stay (LOS)
Time Frame
an average of 1 month
Title
Wound Healing Score
Description
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+
Time Frame
3 and 6 weeks after craniotomy
Title
The size of surgical incision
Description
Recording the size of surgical incision (unit: centimeter)
Time Frame
at the end of the craniotomy
Title
The duration of operation
Description
Recording the duration of operation (unit:minute)
Time Frame
at the end of the craniotomy
Title
Rate of postoperative complications
Description
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
Time Frame
within 30 days after craniotomy
Title
Postoperative antibiotic usage
Description
postoperative antibiotic usage
Time Frame
within 30 days after craniotomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having signed the informed consent,
age 18-80 yrs,
American Society of Anaesthesiologists (ASA) physical status of I or II,
scheduled elective supratentorial craniotomy,
planned head fixation in a skull clamp.
Exclusion Criteria:
Allergy to LAs,
alcohol abuse,
intracranial hypertension,
active psychiatric disorders,
uncontrolled epilepsy,
chronic opioid use (more than 2 weeks),
undergoing a revision craniotomy,
high probability of having postoperative radio- or chemotherapy,
expectation of delayed extubation or no planned extubation,
pregnancy or breastfeeding during the study,
extreme body mass index (BMI) (less than 15 or more than 40),
preoperative Glasgow Coma Scale less than 15,
undergoing emergency or awake craniotomy surgery,
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Luo
Phone
+86 13611326978
Email
13611326978@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Chen
Phone
+86 15010130151
Email
zchan1011@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Luo
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
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