A Phase 4 interventional study of Ketorolac and Ropivacaine in Pain and Supratentorial Brain Tumor, sponsored by Beijing Tiantan Hospital. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Prevention
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 40 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
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Exclusion Criteria:
Patients assigned to the ketorolac group will receive pre-emptive scalp infiltration with 30ml of local infiltration solution containing 60 mg ropivacaine, 6 mg ketorolac and 0.1mg epinephrine.
Drug: Ketorolac · Drug: Ropivacaine · Drug: Epinephrine
In the control group, preoperative peri-incisional scalpinfiltration will be performed using 30ml of 60 mgropivacaine and 0.1mg epinephrine.
Drug: Ropivacaine · Drug: Epinephrine
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.
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
No study locations are listed for this record.
Plan to share: Yes
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital