Clinical trial NCT03915639: Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
Official title: Effect of the Peri-incisional Multimodal Cocktail Infiltration on Postcraniotomy Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Keywords: Post-Craniotomy Headache
Postoperative Pain
Cocktail
Analgesia
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Cumulative morphine consumption
timeFrame: 24 hours after recovery
Secondary outcomes:
measure: Postoperative 0-10 Numeric Rating Score
timeFrame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy
measure: Rate of post-operative opioid-related side effects
timeFrame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery
measure: Time interval to first PCA demand
timeFrame: within 24 hours after recovery
measure: Total PCA press counts
timeFrame: within 24 hours after recovery
measure: Total rescue medication usage
timeFrame: within 24 hours after recovery
measure: Recovery
timeFrame: an average of 1 month
measure: Wound Healing Score
timeFrame: 3 and 6 weeks after craniotomy
measure: The size of surgical incision
timeFrame: at the end of the craniotomy
measure: The duration of operation
timeFrame: at the end of the craniotomy
measure: Rate of postoperative complications
timeFrame: within 30 days after craniotomy
measure: Postoperative antibiotic usage
timeFrame: within 30 days after craniotomy
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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