Cranial Blocks for Postoperative Anesthesia

NCT04749797 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 834603
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Craniotomy Surgery

Keywords

craniotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Length of Stay (ICU and

  10 months (study terminated)

Study Arms (3)

Saline group

PLACEBO COMPARATOR

The surgeon will administer injectable saline as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion.

Drug: Saline

Bupivacaine

ACTIVE COMPARATOR

The surgeon will administer bupivacaine as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion.

Drug: Bupivacaine Injection

Liposomal Bupivacaine

EXPERIMENTAL

The surgeon will administer Exparel (liposomal bupivacine) as a cranial block. 20 mL of Exparel will be diluted with saline to constitute 60 mL total. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion.

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

Used as cranial block for craniotomy surgery

Liposomal Bupivacaine

Bupivacaine Injection DRUG

Used as cranial block for craniotomy surgery

Bupivacaine

Saline DRUG

Used as cranial block for craniotomy surgery

Saline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Need for elective supratentorial craniotomy
• Preoperative GCS \> 13

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Study concluded before reaching subject n goal due to slow enrollment related to COVID-19 pandemic and PI leaving institution. Sample size not significant enough to accurately analyze data.

Results Point of Contact

• Title: Timothy Lucas
• Organization: University of Pennsylvania

Timothy.Lucas@pennmedicine.upenn.edu

(215) 662-3487

Study Officials

• Timothy H Lucas, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: On the morning of the procedure, participants will be assigned sequentially to the lowest unassigned randomization number. The surgeon performing the procedure and operating room staff will not be blinded to the intervention, since they will see whether the patient is receiving liposomal bupivacaine, bupivacaine or saline. However, all providers obtaining post-operative data from the patients will be blinded as to which treatment the patient received, in addition to the patient themselves.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Participants will be randomized to one of three groups: saline, bupivacaine, liposomal bupivacaine

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: February 11, 2021
• Study Start: September 2, 2020
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Locations

US (1)