Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement

• Sponsor: University of Minnesota (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06143306
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

The use of ISB in patients undergoing total shoulder arthroplasty (TSA) is the gold standard and results in significantly reduced pain scores and opioid use. However, patients still have pain and the majority require opioids postoperatively as the interscalene block (ISB) doesn't cover all of the dermatomes impacted during TSA. A pectoserratus block typically provides coverage to additional dermatomes that are impacted during TSA. Currently ISB is performed for every patient and perform a pectoserratus block to a portion of our patients undergoing TSA. The purpose of the study is to determine if the addition of the pectoserratus block to the ISB will results in improvement in pain control and decrease in opioid use, among patients undergoing TSA. This is a randomized prospective controlled trial. All patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty aged 18-85 will be considered eligible for the study. Participants will be randomized to one of 2 treatment groups. Group 1 will receive an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine. Group 2 will be the control and receive an ultrasound guided pectoserratus block with 25 mL of saline. The drug will be administered by the anesthesiologist in-charge of the participant's care or an anesthesiologist who is a part of the study team.

Condition or Disease	Intervention/Treatment	Phase
Total Shoulder Arthroplasty	Drug: bupivacaine.; Drug: Saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: This will be double blinded. The surgeon performing the surgery and the research team member collecting follow-up pain and opioid data will be blinded to the randomization assigned to the patient. The anesthesiologist performing the block and the medical assistant preparing the drugs for the anesthesiologist will be unblinded.
• Primary Purpose: Supportive Care
• Official Title: Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
• Anticipated Study Start Date: Nov 30, 2023
• Anticipated Primary Completion Date: May 30, 2026
• Anticipated Study Completion Date: Nov 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine group Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the experimental group.	Drug: bupivacaine.; an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine
Placebo Comparator: control group Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the control group.	Drug: Saline; an ultrasound guided pectoserratus block with 25 mL of saline

Outcome Measures

Primary Outcome Measures

1. Maximum pain [24 hours postop]

   This measurement is the highest pain score within the first 24 hours post-op. Please change abbreviations for time frames to minutes, hours and years respectively. And the Scale is 0 being no pain to 10 being worst pain.

Secondary Outcome Measures

1. Opioid use [24 hours postop, 48 hours postop]

   Opioid use reported as MME

2. Functional pain score [24 hours postop, 48hours postop]

   The scale used in a modified QOR (quality of Recovery) scale. It's 15 questions based off the adult QOR scale which assesses impact of pain on the patient's daily activities

3. hospital length of stay [5 days]

   This is a standard post-operative outcome that relates to the surgical recovery period. Idon't know what options you have to select for time frame, but please either select post-op or explain this standard.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty;

• Patients aged 18-85 years old.

Exclusion Criteria:

• Patients who have an exclusion to regional anesthesia such as pre-existing nerve damage to their brachial plexus or infection at the site of injection.

• Patients who have exclusion to interscalene blockade such as severe lung disease.

• Non-English speakers will be excluded because pain scales are not validated in other languages and there is lack of standardization of pain reporting.

• Pregnant patients

• Patients who are currently using opioids and patients with a diagnosis of chronic pain will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Jacob Hutchins, MD, MHA, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT06143306
• Other Study ID Numbers: pectoserratus block
• First Posted: Nov 22, 2023
• Last Update Posted: Nov 22, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Bupivacaine

Study Results

No Results Posted as of Nov 22, 2023