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

Capital Medical University

Status: Unknown

Conditions: Pain, Postoperative

Treatments: Procedure: Peri-incisional injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03915639

KY 2018-035-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cocktail

Experimental group

Description:

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.

Treatment:

Procedure: Peri-incisional injection

Ropivacaine

Active Comparator group

Description:

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.

Treatment:

Procedure: Peri-incisional injection