Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache

Pain, Postoperative Clinical Trial

Official title:

Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03915639
• Other study ID #: KY 2018-035-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: December 2023

Study information

• Verified date: May 2020
• Source: Beijing Tiantan Hospital
• Contact: Fang Luo
• Phone: +86 13611326978
• Email: 13611326978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Having signed the informed consent,

2. age 18-80 yrs,

3. American Society of Anaesthesiologists (ASA) physical status of I or II,

4. scheduled elective supratentorial craniotomy,

5. planned head fixation in a skull clamp.

Exclusion Criteria:

1. Allergy to LAs,

2. alcohol abuse,

3. intracranial hypertension,

4. active psychiatric disorders,

5. uncontrolled epilepsy,

6. chronic opioid use (more than 2 weeks),

7. undergoing a revision craniotomy,

8. high probability of having postoperative radio- or chemotherapy,

9. expectation of delayed extubation or no planned extubation,

10. pregnancy or breastfeeding during the study,

11. extreme body mass index (BMI) (less than 15 or more than 40),

12. preoperative Glasgow Coma Scale less than 15,

13. undergoing emergency or awake craniotomy surgery,

14. inability to understand the use of the NRS or the PCA. (Patients are informed of the instructions of NRS (from 0 to 10, where 0 and 10 represent no pain and the worst imaginable pain, respectively) and PCA after signing the informed consent the day before the operation. Patients who cannot understand the instruction of NRS and PCA will be excluded from the study.)

Related Conditions & MeSH terms

• Headache
• Pain, Postoperative

Intervention

Procedure:
• Peri-incisional injection
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

References & Publications (13)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2007 Jul 26. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative morphine consumption	cumulative morphine consumption through PCA within 24 hours after recovery	24 hours after recovery
Secondary	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
Secondary	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).; Awake and alert,; Slightly drowsy, easily aroused,; Frequently drowsy, arousable, drift off to sleep during a conversation,; Somnolent, minimal or no response to verbal or physical stimulation A POSS score of 3 or 4 is defined as oversedation.; 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
Secondary	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
Secondary	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
Secondary	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
Secondary	Recovery	Time to PACU discharge, time to ambulation, and length of stay (LOS)	an average of 1 month
Secondary	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
Secondary	The size of surgical incision	Recording the size of surgical incision (unit: centimeter)	at the end of the craniotomy
Secondary	The duration of operation	Recording the duration of operation (unit:minute)	at the end of the craniotomy
Secondary	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
Secondary	Postoperative antibiotic usage	postoperative antibiotic usage	within 30 days after craniotomy