Pain, Supratentorial Brain Tumor
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGKetorolac
30ml of local infiltration solution containing 60mg ropivacaine
DRUGRopivacaine
30ml of local infiltration solution containing 6mg ketorolac
DRUGEpinephrine
30ml of local infiltration solution containing 0.1mg epinephrine
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for elective supratentorial tumour resection; * Planned general anaesthesia; * American Society of Anesthesiologists (ASA) physical status I - II; * Age ranging from 18 to 65 years old; * Participates required to fix their head in a head clamp intraoperatively; * Participates with an anticipated awake within 2 hours after surgery.
Exclusion criteria
* Allergy/intolerance to study drugs including anesthetic drugs, ketorolac and epinephrine; * Expected delayed extubation or no plan to extubate; * History of neurosurgeries; * Long-term use of analgesics and sedatives (more than 2 weeks) * Receiving any painkiller within 24 h before the operation; * Extreme body mass index (BMI) (less than 15 or more than 35); * Patients with impaired cardiopulmonary; * Patients with impaired renal function; * Patients with impaired hepatic function; * History of chronic headache; * Patients with cognitive deficit; * Patients with intellectual disability; * Patients with uncontrolled epilepsy; * Patients with psychiatric disorders; * Difficulties in using PCA device * Difficulties in understanding the use of numeral rating scale (NRS) ; * Patients with suspected intracranial hypertension; * Pregnant or at breastfeeding; * Infection at the incisional site； * History of radiation therapy and chemotherapy preoperatively * With great likelihood of postoperative radiation therapy and chemotherapy based on preoperative imaging.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively | 0 to 48 hours postoperatively | The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| frequency of pressing patient-controlled analgesia pump | Within 48hours postoperatively | frequency of patient-controlled analgesia pump |
| numeral rating scale (NRS) Score | 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 | 0 forno pain and 10 for 'pain as severe as you can imagine |
| Pain control satisfaction score (PCSS) postoperatively | at 24 hours, 48 hours, 72 hours, 1 week, 1 month, 3 months and 6 months | 0 for unsatisfactory and 10 for very satisfactory |
| Ramsay sedation score (RSS) | at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours and 72 hours postoperatively | 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. |
| pulse oxygen saturation(SpO2) | 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 | SpO2 |
| mean arterial blood pressure(MAP) | 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 | MAP |
| The time to first request for patient-controlled analgesia butorphanol | Within 48hours postoperatively | The time to first request for patient-controlled analgesia butorphanol |
| respiratory rate(RR) | 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 | RR |
| Length of hospital stay | Length of hospital stay, an arverage of 2 weeks | Length of hospital stay |
| Wound healing score | at 3 weeks and 6 weeks after surgery | 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 |
| postoperative nausea and vomiting(PONV) | within 48 hours postoperatively | 0, absent; 1, nausea but not requiring treatment; 2, nausea requiring treatment; and 3, vomiting |
| The presence of respiratory depression | within 48 hours postoperatively | respiratory rate \<10 breaths per minute or SpO2 was\<90 % |
| The incidence of haematoma, wound infection or gastric ulcers | during hospitalization, within 2 weeks postoperatively | side effects |
| heart rate(HR) | 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 | HR |
Contacts
Primary ContactFang Luo, M.D
Backup ContactYitong Jia, M.D
Outcome results
None listed