The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical 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.
The proposed study will be a single-center, prospective, randomized, open-label, blinded-endpoint clinical trial designed to test the hypothesis that the addition of ketorolac to pre-emptive scalp infiltration analgesia can significantly improve analgesia after craniotomies. One hundred participants will be randomized to the ketorolac group or the control group. Patients in the ketorolac group will receive pre-emptive scalp infiltration with opivacaine,ketorolac and epinephrine while patients in the control group will receive pre-emptive scalp infiltration with ropivacaine and epinephrine.The primary outcome measure will be cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
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) 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 patient-controlled analgesia butorphanol
The time to first request for patient-controlled analgesia butorphanol
Time frame: Within 48hours postoperatively
frequency of pressing patient-controlled analgesia pump
frequency of patient-controlled analgesia 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, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months postoperatively
Pain control satisfaction score (PCSS) postoperatively
0 for unsatisfactory and 10 for very satisfactory
Time frame: at 24 hours, 48 hours, 72 hours, 1 week, 1 month, 3 months and 6 months
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 light glabellar 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 light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours and 72 hours postoperatively
pulse oxygen saturation(SpO2)
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)
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)
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)
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 postoperatively
Length of hospital stay
Length of hospital stay
Time frame: Length of hospital stay, an arverage of 2 weeks
Wound healing score
Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: \>3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis \>3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: \>3-6 cm not regrowing; 4: \>6 cm not regrowing; not applicable
Time frame: at 3 weeks and 6 weeks after surgery
postoperative nausea and vomiting(PONV)
0, absent; 1, nausea but not requiring treatment; 2, nausea requiring treatment; and 3, vomiting
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