Cranial Blocks for Postoperative Anesthesia

Craniotomy Surgery Clinical Trial

Official title:

Randomized Study Of Cranial Blocks For Postoperative Anesthesia To Reduce Pain And Postoperative Opioid Usage

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04749797
• Other study ID #: 834603
• Status: Terminated
• Phase: Phase 4
• Start date: September 2, 2020
• Est. completion date: July 20, 2021

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.

Description:

Objective: To assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy.

The investigators will employ a randomized, single-blinded, prospective study design. Participants will be randomized 1:1:1 into one of three treatment groups: Bupivacaine, Liposomal Bupivacaine, and Saline.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age

• Need for elective supratentorial craniotomy

• Preoperative GCS > 13

Exclusion Criteria:

• Preoperative GCS = 13

• Child (<18 years of age)

• Inability to understand or use the visual analog scale (VAS)

• Proven or suspected allergy to local anesthetics

• Craniotomy incision extending beyond the field of the block

• Patients chronically (more than 2 wk) treated with narcotic medications

• Previous scalp incision

• Bilateral craniotomies

• Allergies to local anesthetics

• GCS verbal score < 4 after extubation

• Patients whose surgeries extend past 6 hours (will be placed on standard of care and removed from study)

• Patients currently on ergot-type oxytoxic drugs, MAOIs, or certain antidepressants

• Lactating Mothers

Related Conditions & MeSH terms

• Craniotomy Surgery

Intervention

Drug:
• Liposomal bupivacaine
Used as cranial block for craniotomy surgery
• Bupivacaine Injection
Used as cranial block for craniotomy surgery
• Saline
Used as cranial block for craniotomy surgery

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	The Visual Analogue Scale (VAS) is a straight, horizontal line of fixed length, numbered 0 to 10 as a measure of pain severity. The ends are the extreme limits of this scale, with the left side (0) representing the best outcome (no pain), and the right side (10) representing the worst outcome, extreme pain. The other numbers in between are representations of the variation in pain between these two feelings. The scale is presented to the participant with a verbal explanation of its meaning, and the participant points to or states a number indicating where they feel their pain level is best represented on the scale. That number is recorded.; For each group, every participant reported several different pain scores over multiple hours. The averages (means) below represent the summation of all of the pain scores reported throughout their admission.	10 months (study terminated prior to completion)
Secondary	Length of Stay (ICU and	The secondary outcome variables are the duration of stay in the intensive care unit (ICU), and the duration of time in the hospital until discharge.	10 months (study terminated)