The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical pilot 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
40
30ml of local infiltration solution containing 60mg ropivacaine
30ml of local infiltration solution containing 6mg ketorolac
30ml of local infiltration solution containing 0.1mg epinephrine
cumulative doses of patient-controlled analgesia (PCA) sufentanil consumption
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
Time frame: 0 to 48 hours postoperatively
The time to first request for PCA sufentanil
The time to first request for patient-controlled analgesia
Time frame: 0 to 48 hours postoperatively
frequency of pressing PCA pump
frequency of pressing PCA pump
Time frame: Within 48hours postoperatively
numeral rating scale (NRS) Score
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 postoperatively
Pain control satisfaction score (PCSS) postoperatively
0 for unsatisfactory and 10 for very satisfactory
Time frame: at 24 hours and 48 hours post-operation
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 lightglabellar 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 lightglabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.
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Time frame: at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively
pulse oxygen saturation(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
mean arterial blood pressure(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
heart rate(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
respiratory rate(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 postope
Length of hospital stay
Time frame: Length of hospital stay, an arverage of 2 weeks
postoperative nausea and vomiting(PONV)
Time frame: within 48 hours postoperatively
The presence of respiratory depression
respiratory rate \<10 breaths per minute or SpO2 was\<90 %
Time frame: within 48 hours postoperatively
The incidence of haematoma, wound infection or gastric ulcers
side effects
Time frame: during hospitalization, within 2 weeks postoperatively