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Exparel Interscalene vs Indwelling Catheter

Prospective Randomized Control Trial Evaluating Single Shot Exparel Versus Indwelling Interscalene Catheter for Total Shoulder Replacements- A Pilot Study

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03827213
Enrollment
23
Registered
2019-02-01
Start date
2019-01-22
Completion date
2021-06-01
Last updated
2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

shoulder surgery, post operative pain

Brief summary

The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel).

Detailed description

While placing an indwelling nerve catheter can prolong pain control, it can also have drawbacks and complications. While major complications like pneumothorax and hemidiaphragmatic paresis from interscalene continuous peripheral nerve blocks (CPNB) are rare, minor adverse effects associated with CPNBs may be more common. They include infection and anatomical damage to blood vessels and nerves due to the indwelling catheter. In addition, catheters take a significantly longer time to set up and place than single shot blocks, which is important as there is often a rush to block patients and trying to get them into the operating room on time. Furthermore, the needle used for catheter placement is larger than the single shot needles, which creates more discomfort to patients during the nerve block. The catheter itself is taped around the entire sides and back of the patient's neck, which is also uncomfortable for patients. Because of how shallow the interscalene block is, the catheter is often found to be dislodged from operating room positioning, patient transport or movement, which negates the placement of the catheter. An indwelling catheter must also be followed up by the acute pain service team until the catheter is removed. Exparel, or liposomal bupivacaine, is formulated to release low dose bupivacaine over 96 hours, and was recently approved by the FDA in April 2018 to be used in interscalene blocks. The sustained release of local anesthetic could theoretically act similarly to the continuous infusion of local anesthetic through an indwelling interscalene catheter, and could thus avoid the need for placement of a catheter. Current existing data, although inconclusive, has in some studies shown an equal analgesic effect as catheters. As per pharmacy, the cost of the On-Q pump and the local anesthesia needed for the pump together cost $390 for each indwelling catheter placed, not including the cost of anesthesia and pharmacy supplies and labor. The cost of each 20 mL vial of Exparel is less at $285 and, for a single shot nerve block, would avoid the extra costs and time needed for a catheter placement. The investigators would like to perform a prospective randomized controlled pilot study to examine the efficacy of single shot interscalene blocks using Exparel versus the traditional interscalene catheter used at our institution. The purpose of the study the investigators are proposing is to determine if single shot interscalene nerve blocks using Exparel can provide equivalent or better analgesia than indwelling interscalene catheter in patients who undergo total shoulder replacement surgery. If so, single shot interscalene nerve blocks with Exparel may serve as a quicker, easier, cheaper, safer, and more comfortable alternative to placing indwelling interscalene catheters.

Interventions

DRUGExparel

A shot of long acting local anesthetic for post operative pain management

DEVICEIndwelling Interscalene Catheter

ropivacaine, given through a catheter inserted between the shoulders

Sponsors

Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesia (ASA) 1, 2, and 3 * Ages 40-74 * Patients scheduled for total shoulder replacement

Exclusion criteria

* ASA 4 and 5 * Pre-existing pain disorder * Regular consumption of chronic pain medication * pregnant women * any medical condition such as a clotting disorder * anatomic abnormality that precludes use of an indwelling scalene catheter * Body Mass Index (BMI) \>40 * Patient refusal * Pre-existing diabetic neuropathy or Hemoglobin A1c \>9 * Failed block

Design outcomes

Primary

MeasureTime frameDescription
Opioid Requirements Assessed at 24 Hours Post-surgery24 Hours post-surgeryParticipant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.

Secondary

MeasureTime frameDescription
Intra-Operative Opioid RequirementsDuration of Surgery (Approximately 3 hours)Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.
Opioid Requirements Assessed at 8-hours Post-surgery8 hour post-surgery8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.
Pain Score in Post Anesthesia Care Unit (PACU)During time in PACU (up to 5 hours)Collecting patient pain scores in the Post Anesthesia Care Unit (PACU). Participant will be asked to rate their pain score from 0 (no pain) to10 (worst pain)
Opioid Requirements Assessed at 48 Hours Post-surgery48 hours post-surgery48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.

Other

MeasureTime frameDescription
Length of StayAt Discharge (up to 3 days)Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.

Countries

United States

Participant flow

Participants by arm

ArmCount
Single Shot Interscalene Nerve Block
This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.
11
Indwelling Interscalene Catheter
This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The On-Q pump was set at a rate of 4 mL/hr.
12
Total23

Baseline characteristics

CharacteristicIndwelling Interscalene CatheterTotalSingle Shot Interscalene Nerve Block
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
8 Participants16 Participants8 Participants
Age, Categorical
Between 18 and 65 years
4 Participants7 Participants3 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
12 participants23 participants11 participants
Sex: Female, Male
Female
7 Participants12 Participants5 Participants
Sex: Female, Male
Male
5 Participants11 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 12
other
Total, other adverse events
1 / 112 / 12
serious
Total, serious adverse events
0 / 110 / 12

Outcome results

Primary

Opioid Requirements Assessed at 24 Hours Post-surgery

Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.

Time frame: 24 Hours post-surgery

Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.

Secondary

Intra-Operative Opioid Requirements

Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.

Time frame: Duration of Surgery (Approximately 3 hours)

Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.

Secondary

Opioid Requirements Assessed at 48 Hours Post-surgery

48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.

Time frame: 48 hours post-surgery

Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.

Secondary

Opioid Requirements Assessed at 8-hours Post-surgery

8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.

Time frame: 8 hour post-surgery

Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.

Secondary

Pain Score in Post Anesthesia Care Unit (PACU)

Collecting patient pain scores in the Post Anesthesia Care Unit (PACU). Participant will be asked to rate their pain score from 0 (no pain) to10 (worst pain)

Time frame: During time in PACU (up to 5 hours)

Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.

Other Pre-specified

Length of Stay

Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.

Time frame: At Discharge (up to 3 days)

Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026