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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Cumulative morphine consumption
cumulative morphine consumption through PCA within 24 hours after recovery
Time frame: 24 hours after recovery
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.
Time frame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy
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). 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.
Time frame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery
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
Time frame: within 24 hours after recovery
Total PCA press counts
The PCA device will automatically record the total press counts based on a specially designed algorithm.
Time frame: within 24 hours after recovery
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.
Time frame: within 24 hours after recovery
Recovery
Time to PACU discharge, time to ambulation, and length of stay (LOS)
Time frame: an average of 1 month
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+
Time frame: 3 and 6 weeks after craniotomy
The size of surgical incision
Recording the size of surgical incision (unit: centimeter)
Time frame: at the end of the craniotomy
The duration of operation
Recording the duration of operation (unit:minute)
Time frame: at the end of the craniotomy
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
Time frame: within 30 days after craniotomy
Postoperative antibiotic usage
postoperative antibiotic usage
Time frame: within 30 days after craniotomy
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