Pectoserratus Block + Interscalene Block for Shoulder Surgery
Recruiting in Palo Alto (17 mi)
Overseen byJacob Hutchins, MD, MHA
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Minnesota
Must not be taking: Opioids
Disqualifiers: Nerve damage, Severe lung disease, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are currently using opioids or have chronic pain.
What data supports the effectiveness of the treatment Pectoserratus Block + Interscalene Block for Shoulder Surgery?
Research shows that the Interscalene Brachial Plexus Block (ISB) is effective for reducing pain and the need for opioids after shoulder surgery, and using ultrasound improves its success and safety.
12345Is the Pectoserratus Block + Interscalene Block for shoulder surgery safe?
The Interscalene Block, used in shoulder surgeries, is generally safe but can have side effects like temporary voice changes, low heart rate, low blood pressure, and nerve issues. Most complications are temporary, and using ultrasound guidance can help reduce risks.
46789How does the interscalene block treatment differ from other treatments for shoulder surgery?
The interscalene block (ISB) is a regional anesthesia technique that specifically targets the nerves in the neck to provide pain relief for shoulder surgeries, offering an alternative to general anesthesia or intravenous sedatives. It is often combined with a serratus plane block to enhance anesthesia quality, making it unique in its ability to provide targeted pain relief and muscle relaxation without the need for additional analgesia.
23101112Eligibility Criteria
This trial is for patients aged 18-85 undergoing total shoulder replacement surgery. It's suitable for those who can receive an ultrasound-guided block as part of their pain management.Inclusion Criteria
I am between 18 and 85 years old.
I am having a total or reverse shoulder replacement surgery.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either a pectoserratus block with bupivacaine or saline during total shoulder arthroplasty
1 day
1 visit (in-person)
Postoperative Monitoring
Participants are monitored for pain and opioid use within the first 48 hours post-operation
2 days
Continuous monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including hospital length of stay and functional pain score
5 days
Participant Groups
The study tests if adding a pectoserratus block with bupivacaine to the standard interscalene block improves pain control and reduces opioid use after shoulder replacement surgery, compared to using saline.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bupivacaine groupExperimental Treatment1 Intervention
Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the experimental group.
Group II: control groupPlacebo Group1 Intervention
Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the control group.
Interscalene Block is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as ISB for:
- Shoulder surgery
- Total shoulder arthroplasty
- Reverse total shoulder arthroplasty
🇪🇺 Approved in European Union as ISB for:
- Shoulder surgery
- Total shoulder arthroplasty
- Reverse total shoulder arthroplasty
🇨🇦 Approved in Canada as ISB for:
- Shoulder surgery
- Total shoulder arthroplasty
- Reverse total shoulder arthroplasty
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Ultrasound guided interscalene brachial plexus block. [2023]Peripheral nerve blocks have long been established as a crucial part of the enhanced recovery pathways after surgery. Interscalene brachial plexus block (ISB) is mainly indicated for anaesthesia and analgesia during shoulder and proximal arm surgery. Ultrasound technology has remarkably improved the efficacy and success rates of the ISB while limiting its potential complications.
Interscalene brachial plexus block for open-shoulder surgery: a randomized, double-blind, placebo-controlled trial between single-shot anesthesia and patient-controlled catheter system. [2022]Interscalene brachial plexus block (ISB) is widely used as an adjuvant regional pain therapy in patients undergoing major shoulder surgery and has proved its effectiveness on postoperative pain reduction and opioid-sparing effect.
Randomized, comparative study of the effectiveness of three different techniques of interscalene brachial plexus block using 0.5% ropivacaine for shoulder arthroscopy. [2019]Interscalene brachial plexus block is an effective regional anesthesia technique for shoulder surgeries. The superiority of the popular ultrasound-guided blocks over peripheral nerve stimulator-confirmed blocks remains unclear. In this study the efficacy of these different block techniques was compared.
Profound Prolonged Bradycardia and Hypotension after Interscalene Brachial Plexus Block with Bupivacaine. [2018]Interscalene brachial plexus blocks have been a routinely performed method of anesthesia for shoulder surgery that decreases the need for general anesthesia, length of stay, and recovery time. We describe a case of bupivacaine toxicity after an interscalene block.
Low interscalene block provides reliable anesthesia for surgery at or about the elbow. [2018]To determine whether interscalene brachial plexus block (ISB) provides adequate anesthesia for surgery on or about the elbow.
Interscalene block anesthesia at an ambulatory surgery center performing predominantly regional anesthesia: a prospective study of one hundred thirty-three patients undergoing shoulder surgery. [2016]Interscalene block (ISB) of the brachial plexus is frequently used for patients undergoing ambulatory shoulder surgery. We previously reported that the incidence of postoperative complaints (neurapraxia) after an ISB was low (3% at 2 weeks), but objective neurologic assessment was not included in the study. The present study combines subjective findings with both preoperative and postoperative objective sensory and motor assessments after an ISB. We prospectively evaluated 133 patients undergoing elective ambulatory shoulder surgery. ISB anesthesia was accomplished by use of 1.5% mepivacaine alone or in combination with bupivacaine (0.5%-0.75%) via a paresthesia technique and a 23-gauge needle. All of the blocks were performed by experienced anesthesiologists. The number of passes with the needle, site of paresthesia, ease of performing the block, and success of the ISB were recorded for each patient. Neurologic assessment was performed preoperatively and up to 2 weeks postoperatively by 1 of 4 health care professionals but not by the anesthesiologists who performed the ISB and included diminished sensation, localized nerve pain, Semmes-Weinstein monofilament pressure threshold sensibility, Weber static 2-point discrimination, and grip strength changes. Patients with postoperative changes were followed up until resolution of symptoms occurred. Successful surgical anesthesia was achieved in 98% of the patients. There was 1 major perioperative complication (0.7%), a seizure that occurred within 5 minutes of the ISB. Two (1.4%) complained of transient postoperative neurapraxias. Neither patient had any changes in objective sensory and motor measurements. Hence, there was no correlation between subjective complaints and objective findings in this study. This study demonstrates that, in the hands of anesthesiologists doing predominantly regional anesthesia, there is a 1.4% incidence of neurologic complications after an ISB. ISB is a safe and effective technique for patients undergoing ambulatory shoulder surgery when an anesthesiologist experienced with regional anesthesia is involved.
Interscalene block anesthesia for shoulder surgery. [2022]One hundred patients had major shoulder surgery with interscalene brachial and cervical plexus block anesthesia. Successful anesthesia was obtained by using this method in 82 patients. Failure was the result of incomplete anesthesia in 16 patients or the presence of a complication. Complications from high blood levels of anesthetic included loss of consciousness and respiratory depression in three patients and seizure in one. The block lasted a mean of eight hours, decreasing the need for postoperative analgesic medications. No postoperative medical complication developed. Ninety-one percent of the patients with successful blocks were satisfied with the procedure.
Pleural effusion and atelectasis during continuous interscalene brachial plexus block -A case report-. [2021]An interscalene brachial plexus block is an effective means of providing anesthesia-analgesia for shoulder surgery. However, it has a multitude of potential side effects such as phrenic nerve block. We report a case of a patient who developed atelectasis of the lung, and pleural effusion manifested as chest discomfort during a continuous interscalene brachial plexus block for postoperative analgesia.
Prolonged dysphonia as a complication of interscalene block. [2022]The interscalene block (ISB) of the brachial plexus is a common technique for anaesthesia and the treatment of postoperative pain in shoulder surgery. Despite the well-known advantages of this technique, it is not without risks that need to be identified and taken into account. The most frequent complications associated with it are of a neurological nature and most are transient. It has been shown that the use of nerve stimulation does not guarantee a safe block. Ultrasound guidance now makes it possible to visualise potentially dangerous structures, thus allowing us to reduce the risk of associated complications. We present the case of a patient with transient dysphonia secondary to recurrent laryngeal nerve palsy. We also discuss briefly the most common complications associated with the technique.
Interscalene brachial plexus blocks in the management of shoulder dislocations. [2019]Interscalene brachial plexus block is a simple and effective alternative to intravenous benzodiazepines or general anaesthesia for manipulation of the dislocated shoulder. Thirty interscalene brachial plexus blocks were performed on 29 patients with dislocations of the shoulder to provide regional anaesthesia for reduction. Pain was abolished by 14 out of the 30 blocks performed, improved by 13 and unchanged by three. Muscle relaxation (MRC grade 3 or less) occurred in 21 patients. In 26 cases the block allowed reduction of the dislocation without additional analgesia or sedative. Reduction was not possible in four cases. There were no significant complications.
Does the Serratus Plane Block Added to the Interscalene Block Improve the Quality of Anesthesia in Arthroscopic Shoulder Surgery? A Prospective Randomized Study. [2020]Interscalene brachial plexus block (ISBPB) is the gold standard method in shoulder surgery. Serratus plane block (SPB) provides anesthesia in hemithorax, axillary region, and posterior of the shoulder. This randomized controlled study evaluated the effect of SPB added to ISBPB on surgical anesthesia quality in arthroscopic shoulder surgery.
Clinical report: interscalene block for shoulder operations. [2018]Administration of adequate volumes of local anaesthetic through a single injection into the interscalene space produces blockade of both the brachial and cervical plexuses. A report of 2 patients who underwent operative repair of recurrent dislocation of the shoulder under interscalene block is presented. The advantages and disadvantages of the block for surgery around the shoulder region, and the possible complications are discussed.