NCT03915639

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
3 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

April 9, 2019

Last Update Submit

May 24, 2020

Conditions

Pain, Postoperative

Keywords

Post-Craniotomy HeadachePostoperative PainCocktailAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Cumulative morphine consumption

    cumulative morphine consumption through PCA within 24 hours after recovery

    24 hours after recovery

Secondary Outcomes (11)

  • Postoperative 0-10 Numeric Rating Score

    1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy

  • Rate of post-operative opioid-related side effects

    1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery

  • Time interval to first PCA demand

    within 24 hours after recovery

  • Total PCA press counts

    within 24 hours after recovery

  • Total rescue medication usage

    within 24 hours after recovery

  • +6 more secondary outcomes

Study Arms (2)

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.

Procedure: Peri-incisional injection

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.

Procedure: Peri-incisional injection

Interventions

Peri-incisional injectionPROCEDURE

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.

CocktailRopivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having signed the informed consent,
  • age 18-80 yrs,
  • American Society of Anaesthesiologists (ASA) physical status of I or II,
  • scheduled elective supratentorial craniotomy,
  • planned head fixation in a skull clamp.

You may not qualify if:

  • Allergy to LAs,
  • alcohol abuse,
  • intracranial hypertension,
  • active psychiatric disorders,
  • uncontrolled epilepsy,
  • chronic opioid use (more than 2 weeks),
  • undergoing a revision craniotomy,
  • high probability of having postoperative radio- or chemotherapy,
  • expectation of delayed extubation or no planned extubation,
  • pregnancy or breastfeeding during the study,
  • extreme body mass index (BMI) (less than 15 or more than 40),
  • preoperative Glasgow Coma Scale less than 15,
  • undergoing emergency or awake craniotomy surgery,
  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 25903913BACKGROUND

  • 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.

    PMID: 23352875BACKGROUND

  • 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.

    PMID: 28890034BACKGROUND

  • 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.

    PMID: 29117012BACKGROUND

  • 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.

    PMID: 19239675BACKGROUND

  • 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.

    PMID: 20717011BACKGROUND

  • 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.

    PMID: 18484242BACKGROUND

  • 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.

    PMID: 16651569BACKGROUND

  • 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.

    PMID: 17823012BACKGROUND

  • 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.

    PMID: 23850410BACKGROUND

  • 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.

    PMID: 26072302BACKGROUND

  • 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.

    PMID: 24706022BACKGROUND

  • 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.

    PMID: 16452738BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Fang Luo

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Luo

CONTACT

+86 1361132697813611326978@163.com

Zheng Chen

CONTACT

+86 15010130151zchan1011@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Pain Management

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 16, 2019

Study Start

April 1, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

May 27, 2020

Record last verified: 2020-05