Cranial Blocks for Postoperative Anesthesia

Sponsor

University of Pennsylvania (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04749797

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Craniotomy Surgery	Drug: Liposomal bupivacaine Drug: Bupivacaine Injection Drug: Saline	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Care Provider)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 2, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Saline group The surgeon will administer injectable saline as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 Used as cranial block for craniotomy surgery
Active Comparator: Bupivacaine The surgeon will administer bupivacaine as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 Used as cranial block for craniotomy surgery
Experimental: Liposomal Bupivacaine The surgeon will administer Exparel (liposomal bupivacine) as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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 Used as cranial block for craniotomy surgery

Arm

Intervention/Treatment

Placebo Comparator: Saline group

The surgeon will administer injectable saline as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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

Used as cranial block for craniotomy surgery

Active Comparator: Bupivacaine

The surgeon will administer bupivacaine as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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

Used as cranial block for craniotomy surgery

Experimental: Liposomal Bupivacaine

The surgeon will administer Exparel (liposomal bupivacine) as a cranial block according to a technique previously described by Pinosky et al (Pinosky et al., 1996). 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

Used as cranial block for craniotomy surgery

Outcome Measures

Primary Outcome Measures

To assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy. [48 months]
The Glasgow Coma score (GCS) (Teasdale & Jennett, 1974) will also be assessed at the above time points. Patients with GCS verbal score of <4 will be excluded from statistical analysis because of inability to respond to questions after extubation. The cumulative doses of narcotics during this time period will also be measured.

Secondary Outcome Measures

Total narcotic usage, GCS and ICU length of stay [48 months]
The secondary outcome variables are the subjects' cumulative narcotic requirement, Glasgow Coma Score, the duration of stay in the intensive care unit (ICU), the duration of time in the hospital until discharge, and the duration of time from the end of surgery to the first administration of narcotic analgesic. This will be obtained from the medical record.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator: Timothy H Lucas, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Timothy Lucas, MD, PHD, MHCI, Primary Investigator, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT04749797

Other Study ID Numbers:

834603

First Posted:

Feb 11, 2021

Last Update Posted:

Feb 11, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Timothy Lucas, MD, PHD, MHCI, Primary Investigator, University of Pennsylvania

craniotomy

Additional relevant MeSH terms:

Bupivacaine

Study Results

No Results Posted as of Feb 11, 2021