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

May 24, 2020 updated by: Fang Luo, Beijing Tiantan Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cocktail
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
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.
Active Comparator: Ropivacaine
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative morphine consumption
Time Frame: 24 hours after recovery
cumulative morphine consumption through PCA within 24 hours after recovery
24 hours after recovery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative 0-10 Numeric Rating Score
Time Frame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery and 3 and 6 months after craniotomy
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
Rate of post-operative opioid-related side effects
Time Frame: 1, 2, 4, 6, 12, 24, 48 and 72 hours after recovery

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).

  1. Awake and alert,
  2. Slightly drowsy, easily aroused,
  3. Frequently drowsy, arousable, drift off to sleep during a conversation,
  4. 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
Time interval to first PCA demand
Time Frame: within 24 hours after recovery
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
Time Frame: within 24 hours after recovery
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
Time Frame: within 24 hours after recovery
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 Frame: an average of 1 month
Time to PACU discharge, time to ambulation, and length of stay (LOS)
an average of 1 month
Wound Healing Score
Time Frame: 3 and 6 weeks after craniotomy

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
Time Frame: at the end of the craniotomy
Recording the size of surgical incision (unit: centimeter)
at the end of the craniotomy
The duration of operation
Time Frame: at the end of the craniotomy
Recording the duration of operation (unit:minute)
at the end of the craniotomy
Rate of postoperative complications
Time Frame: within 30 days after craniotomy
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
Time Frame: within 30 days after craniotomy
postoperative antibiotic usage
within 30 days after craniotomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Fang Luo, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 24, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY 2018-035-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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