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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The ketorolac group | Experimental | 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. |
|
| The control group | Active Comparator | In the control group, preoperative peri-incisional scalp infiltration will be performed using 30ml of 60 mg ropivacaine and 0.1mg epinephrine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | 30ml of local infiltration solution containing 60mg ropivacaine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 to 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| The time to first request for patient-controlled analgesia butorphanol | The time to first request for patient-controlled analgesia butorphanol | Within 48hours postoperatively |
| frequency of pressing patient-controlled analgesia pump |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo, M.D | Contact | +8613611326978 | 13611326978@163.com | |
| Yitong Jia, M.D | Contact | +8613811109032 | 13811109032@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Luo, M.D | Beijing Tiantan Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29285407 | Background | Vacas S, Van de Wiele B. Designing a pain management protocol for craniotomy: A narrative review and consideration of promising practices. Surg Neurol Int. 2017 Dec 6;8:291. doi: 10.4103/sni.sni_301_17. eCollection 2017. | |
| 23514638 | Background | Andersen KV, Nikolajsen L, Haraldsted V, Odgaard A, Soballe K. Local infiltration analgesia for total knee arthroplasty: should ketorolac be added? Br J Anaesth. 2013 Aug;111(2):242-8. doi: 10.1093/bja/aet030. Epub 2013 Mar 20. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ropivacaine |
| Drug |
30ml of local infiltration solution containing 6mg ketorolac |
|
| Epinephrine | Drug | 30ml of local infiltration solution containing 0.1mg epinephrine |
|
frequency of patient-controlled analgesia pump
| Within 48hours postoperatively |
| numeral rating scale (NRS) Score | 0 for"no pain" and 10 for "'pain as severe as you can imagine" | 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 | 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. | at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours and 72 hours postoperatively |
| pulse oxygen saturation(SpO2) | 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 |
| mean arterial blood pressure(MAP) | 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 |
| heart rate(HR) | 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 |
| respiratory rate(RR) | 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 |
| Length of hospital stay | Length of hospital stay | 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 | 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 | within 48 hours postoperatively |
| The presence of respiratory depression | respiratory rate <10 breaths per minute or SpO2 was<90 % | within 48 hours postoperatively |
| The incidence of haematoma, wound infection or gastric ulcers | side effects | during hospitalization, within 2 weeks postoperatively |
| 24196463 | Background | Solovyova O, Lewis CG, Abrams JH, Grady-Benson J, Joyce ME, Schutzer SF, Arumugam S, Caminiti S, Sinha SK. Local infiltration analgesia followed by continuous infusion of local anesthetic solution for total hip arthroplasty: a prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 2013 Nov 6;95(21):1935-41. doi: 10.2106/JBJS.L.00477. |
| 25845547 | Background | Song J, Li L, Yu P, Gao T, Liu K. Preemptive scalp infiltration with 0.5% ropivacaine and 1% lidocaine reduces postoperative pain after craniotomy. Acta Neurochir (Wien). 2015 Jun;157(6):993-8. doi: 10.1007/s00701-015-2394-8. Epub 2015 Apr 7. |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |