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Postcraniotomy headache (PCH) has been underestimated for the past decades. However, current treatments for PCH are either considered insufficient or accompanied by severe side-effects. Some studies revealed that peri-incisional injection of a mixed cocktail that contains ropivacaine, epinephrine, ketorolac, and methylprednisolone showed significant efficacy in relieving postoperative pain after total hip or knee arthroplasty. Previous literature reported that the cause of PCH was related to incision of the scalp and dura, which is considered similar to causes to postoperative pain after total hip or knee arthroplasty. Thus, investigators suppose that the cocktail mixture can better relieve PCH in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocktail | Experimental | Participants in Group Cocktail are planned to infiltrate the head fixation sites after intubation and peri-incisionally prior to skin incision. The infiltration will be performed by the attending neurosurgeon. The muscle and the subcutaneous tissue beneath the fixation sites and incision site will be fully irrigated with the multimodal cocktail. |
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| Ropivacaine | Active Comparator | Participants in Group Ropivacaine are planned to infiltrate the head fixation sites after intubation and peri-incisionally prior to skin incision. The infiltration will be performed by the attending neurosurgeon. The muscle and the subcutaneous tissue beneath the fixation sites and incision site will be fully irrigated with ropivacaine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peri-incisional injection | Procedure | The surgeons are planned to inject the cocktail mixture or ropivacaine to muscles and the subcutaneous tissue beneath the fixation sites and incision site using a 22-gauge needle in a sterile fashion prior to skin incision. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative morphine consumption | cumulative morphine consumption through PCA within 24 hours after recovery | 24 hours after recovery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative 0-10 Numeric Rating Score | Numeric Rating Score is a common used scale in evaluating patients' pain intensity in clinical trials. The scale in the present trial is ranged from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher values represent worse pain intensity. | 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | +86 13611326978 | 13611326978@163.com | |
| Zheng Chen | Contact | +86 15010130151 | zchan1011@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Luo | Beijing Tiantan Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25903913 | Background | Rocha-Filho PA. Post-craniotomy headache: a clinical view with a focus on the persistent form. Headache. 2015 May;55(5):733-8. doi: 10.1111/head.12563. Epub 2015 Apr 22. | |
| 23352875 | Background | Papangelou A, Radzik BR, Smith T, Gottschalk A. A review of scalp blockade for cranial surgery. J Clin Anesth. 2013 Mar;25(2):150-9. doi: 10.1016/j.jclinane.2012.06.024. Epub 2013 Jan 23. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Rate of post-operative opioid-related side effects | Post-operative opioid-related side effects include post-operative opioid-induced oversedation, opioid-induced respiratory depression, pruritus, drowsiness, dizziness, blurred vision, and rash. Opioid-induced oversedation will be evaluated using the Pasero Opioid-induced Sedation Scale (POSS).
Opioid-induced respiratory depression (defined as respiratory rate <8/min and/or oxygen saturation <90% and/or apnoea ≥10 s, excessive sedation or upper airway obstruction. | 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery |
| Time interval to first PCA demand | The PCA device will automatically record the time interval to the first PCA demand based on a specially designed algorithm | within 24 hours after recovery |
| Total PCA press counts | The PCA device will automatically record the total press counts based on a specially designed algorithm. | within 24 hours after recovery |
| Total rescue medication usage | When PCA is not enough for analgesia, rescue medication will be used for relieving severe pain. The total rescue medication usage within 24 hours after recovery will be recorded. | within 24 hours after recovery |
| Recovery | Time to PACU discharge, time to ambulation, and length of stay (LOS) | an average of 1 month |
| Wound Healing Score | Wound Healing Score worksheet for assessment of outcomes in scalp clip versus artery forceps groups in patients undergoing craniotomy. The wound healing evaluation is based on skin healing, infection and hair regrowth. For skin healing, 1 represents fully healed, 2 represents ≤3 cm in total not healed, 3 represents >3 cm not healed, 4 represents areas of necrosis ≤3 cm, and 5 represents areas of necrosis >3 cm. For infection, 1 represents none, 2 represents ≤0.5-cm margin of redness , 3 represents more redness or superficial pus, 4 represents deep infection. For hair regrowth, 1 represents even regrowth along wound, 2 represents ≤3 cm not regrowing , 3 represents 3-6 cm not regrowing, 4 represents >6 cm not regrowing. Excellent wounds, total score of 3; Good wounds, Score 4-5; Suboptimal wounds, Score 6+ | 3 and 6 weeks after craniotomy |
| The size of surgical incision | Recording the size of surgical incision (unit: centimeter) | at the end of the craniotomy |
| The duration of operation | Recording the duration of operation (unit:minute) | at the end of the craniotomy |
| Rate of postoperative complications | Postoperative complications include (1) Operative complications: intracranial infection, cerebral oedema, intracranial haematoma, CSF fistula, reoperation, reintubation and delayed extubation. incision infection, incision haematoma, delayed wound healing; (2) systemic complications: systemic infection, systemic inflammatory response syndrome and sepsis; (3) all-cause mortality | within 30 days after craniotomy |
| Postoperative antibiotic usage | postoperative antibiotic usage | within 30 days after craniotomy |
| 28890034 | Background | Akhigbe T, Zolnourian A. Use of regional scalp block for pain management after craniotomy: Review of literature and critical appraisal of evidence. J Clin Neurosci. 2017 Nov;45:44-47. doi: 10.1016/j.jocn.2017.08.027. Epub 2017 Sep 8. |
| 29117012 | Background | Artime CA, Aijazi H, Zhang H, Syed T, Cai C, Gumbert SD, Ferrario L, Normand KC, Williams GW, Hagberg CA. Scheduled Intravenous Acetaminophen Improves Patient Satisfaction With Postcraniotomy Pain Management: A Prospective, Randomized, Placebo-controlled, Double-blind Study. J Neurosurg Anesthesiol. 2018 Jul;30(3):231-236. doi: 10.1097/ANA.0000000000000461. |
| 19239675 | Background | Schankin CJ, Gall C, Straube A. Headache syndromes after acoustic neuroma surgery and their implications for quality of life. Cephalalgia. 2009 Jul;29(7):760-71. doi: 10.1111/j.1468-2982.2008.01790.x. Epub 2009 Feb 23. |
| 20717011 | Background | Flexman AM, Ng JL, Gelb AW. Acute and chronic pain following craniotomy. Curr Opin Anaesthesiol. 2010 Oct;23(5):551-7. doi: 10.1097/ACO.0b013e32833e15b9. |
| 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. |
| 16651569 | Background | Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344. |
| 17823012 | Background | Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26. |
| 23850410 | Background | Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11. |
| 26072302 | Background | Milani P, Castelli P, Sola M, Invernizzi M, Massazza G, Cisari C. Multimodal Analgesia in Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial on Additional Efficacy of Periarticular Anesthesia. J Arthroplasty. 2015 Nov;30(11):2038-42. doi: 10.1016/j.arth.2015.05.035. Epub 2015 May 23. |
| 24706022 | Background | Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0. |
| 16452738 | Background | Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |