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

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Procedure: Peri-incisional injection

• Registration Number: NCT03915639
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-16
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-24
• Last Update Posted: 2020-05-27
• Study Start: 2022-04
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Peri-incisional injection	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.
Cocktail	Peri-incisional injection	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.

Primary Outcome Measures

Name	Time	Method
Cumulative morphine consumption	24 hours after recovery	cumulative morphine consumption through PCA within 24 hours after recovery

Secondary Outcome Measures

Name	Time	Method
Total rescue medication usage	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.
Recovery	an average of 1 month	Time to PACU discharge, time to ambulation, and length of stay (LOS)
The duration of operation	at the end of the craniotomy	Recording the duration of operation (unit:minute)
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	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.
Time interval to first PCA demand	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
Wound Healing Score	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+
The size of surgical incision	at the end of the craniotomy	Recording the size of surgical incision (unit: centimeter)
Postoperative antibiotic usage	within 30 days after craniotomy	postoperative antibiotic usage
Rate of postoperative complications	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
Rate of post-operative opioid-related side effects	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.
Total PCA press counts	within 24 hours after recovery	The PCA device will automatically record the total press counts based on a specially designed algorithm.