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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.
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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 scalpinfiltration will be performed using 30ml of 60 mgropivacaine 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) 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 | 0 to 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| The time to first request for PCA sufentanil | The time to first request for patient-controlled analgesia | 0 to 48 hours postoperatively |
| frequency of pressing PCA pump | frequency of pressing PCA 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 18484242 | Background | Kerr DR, Kohan L. Local infiltration analgesia: a technique for the control of acute postoperative pain following knee and hip surgery: a case study of 325 patients. Acta Orthop. 2008 Apr;79(2):174-83. doi: 10.1080/17453670710014950. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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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 |
|
| 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 postoperatively |
| Pain control satisfaction score (PCSS) postoperatively | 0 for unsatisfactory and 10 for very satisfactory | 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. | at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively |
| 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 |
| 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 |
| 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 |
| 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 postope |
| Length of hospital stay | Length of hospital stay, an arverage of 2 weeks |
| postoperative nausea and vomiting(PONV) | 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 |
| 25238439 | Background | Niemelainen M, Kalliovalkama J, Aho AJ, Moilanen T, Eskelinen A. Single periarticular local infiltration analgesia reduces opiate consumption until 48 hours after total knee arthroplasty. A randomized placebo-controlled trial involving 56 patients. Acta Orthop. 2014 Dec;85(6):614-9. doi: 10.3109/17453674.2014.961399. Epub 2014 Sep 19. |
| 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. |
| D010335 | Pathologic Processes |
| 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 |