Shoulder Anterior Capsular Block and Interscalene Brachial Plexus Block for Shoulder Arthroscopy

NCT ID: NCT05727345

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-04-30

Brief Summary

The aim of our study is to reveal a comparison between interscalene brachial plexus block and shoulder anterior capsular block with respect to their efficacy on pain relief during perioperative anesthetic management. As intraoperative hemodynamic stability is an important factor for surgeons to achieve better outcomes because of its effect on the quality of arthroscopic visualization for shoulder arthroplasty, the investigators will also observe the effects of this matter.

50 patients scheduled for elective surgery will be randomized by closed envelope method into two groups (n=20) receiving either interscalene brachial plexus block or shoulder anterior capsular block preoperatively. Each group receives standardized general anesthesia and perioperative pain management protocol. Data to be recorded are numeric rating scales, intraoperative and postoperative analgesic use, intraoperative hemodynamic parameters, and arthroscopic visualization score. Moreover, block performance time, motor block, and side effects or complications will be noted.

Detailed Description

Introduction: Pain management after shoulder arthroplasty continues to be challenging. Although interscalene brachial plexus block has been accepted to be the gold standard intervention to relieve pain and improve postoperative outcomes by effecting functional rehabilitation and recovery times, usually results in motor block and complications such as hemi-diaphragmatic paralysis are possible to encounter. For this reason, the research for novel techniques to alleviate these outcomes resumes on the anatomical point of view and ultrasonography guidance. Shoulder anterior capsular block is a recently described interfascial and pericapsular block and is shown to be effective in relieving shoulder pain without motor block or complications.

The aim of our study is to reveal a comparison between interscalene brachial plexus block and shoulder anterior capsular block with respect to their efficacy on pain relief during perioperative anesthetic management along with intraoperative hemodynamic stability, and their effect on the quality of arthroscopic visualization for shoulder arthroplasty.

Material method: Patients scheduled for arthroscopic rotator cuff repair after June 30, 2022, are eligible for this study after ethical board approval. Inclusion criteria are (1) patients aged between 18-90 years with American Society of Anaesthesiologists (ASA) Physical Status classification I to III, (2) diagnosed with rotator cuff rupture, and (3) admitted receiving arthroscopic cuff repair surgery. Written informed consent will be obtained from all participants.

Exclusion criteria are refusal to participate in the study, history of neurologic deficits or neuropathy affecting the brachial plexus; infection at the site of the block application; coagulopathy; pre-existing respiratory dysfunction; allergy to local anesthetics; uncooperative patients who cannot reliably answer to verbal pain evaluation.

All patients will receive standard general anesthesia under standard monitorization; induction with 0,03 mg/kg midazolam, 2 mg/kg propofol, 2 mcg/kg fentanyl, 0,6 mg /kg rocuronium followed by 2% MAC sevoflurane in an air-oxygen mixture for maintenance of anesthesia. Randomization is designed with concealed opaque envelope in a 1:1 ratio into 2 block groups (n= 20): interscalene brachial plexus block (Group A) and shoulder anterior capsular block (Group B). All blocks will be performed before surgical incision by a single experienced regional anaesthesiologist (B.Ç.) under ultrasound guidance with the same local anesthetic doses: 0.375 % bupivacaine anesthetic solution of 10 mL and 2 % lidocaine anesthetic solution of 5 mL. The duration of the block procedure will be recorded by the anesthesia technician. Then the investigator will apply dexamethasone 4 mg (IV) after each block and approximately 15 minutes later the patient will be ready for a surgical incision. Intraoperative hemodynamic values (heart rate, systolic, and mean arterial pressure) will be recorded by the same technician. The same analgesia protocol will be applied as an infusion of remifentanil (0.01 to 0.1 μg · kg-1 · min-1) if only needed to maintain the heart rate and mean blood pressure within 20% of pre-induction values and 1 gr paracetamol. At the end of the surgery, the surgeon who is blind to the groups will decide the arthroscopic visualization score.

After surgery, all patients will be followed by the same orthopaedist who is blind to the patient groups. Also, the patients themselves cannot know their groups as well. Pain will be evaluated both by a numeric rating scale (0-10) and verbal rating scale starting at the post-anesthesia care unit (PACU) and at time intervals 2-6-12-24-48th hours postoperatively. Patients with persistent pain scores higher than 4 of 10 will receive rescue analgesia with 1mg/kg (maximum daily dose, 4x1) tramadol and 1 gr (maximum daily dose, 4x1) paracetamol. The duration of motor blockade if any, the severity of rebound pain and the total amount of analgesic drug used during the postoperative follow-up of the patient will be recorded. Before discharge, patient satisfaction (1. Not at all satisfied, 2. Dissatisfied 3. Moderate 4. Satisfied 5. Very satisfied) will be evaluated and the presence of postoperative side effects and complications will be questioned.

Conditions

Shoulder Arthroscopy; Interscalene Brachial Plexus Block; Shoulder Anterior Capsular Block; Rotator Cuff Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Interscalene

Right after general anesthesia induction and patient intubation, the patient will be placed in the semi-sitting position. Following sterile skin preparation, an interscalene block will be performed by the same anaesthesiologist under ultrasound guidance with an in-plane posterior approach approximately between C6-C7 nerve roots through a 22-gauge 50-mm insulated stimulating needle (StimuPlex Nanoline, Braun). Neurostimulation with an initial current of 0,5 mA, pulse width of 100ms, and a frequency of 2 Hz will be used as protection for intraneural injection, once the needle tip is in proximity to the brachial plexus. 15 mL local anesthetic solution (0.375 % bupivacaine anesthetic solution of 10 mL and 2 % lidocaine anesthetic solution of 5 mL) will be observed to disperse within the interscalene space.

Group Type: ACTIVE_COMPARATOR

Interscalene brachial plexus block

Intervention Type: PROCEDURE

Preoperative ultrasound-guided interscalene brachial plexus block application

SHAC

Right after general anesthesia induction and patient intubation, the patient will be placed in the semi-sitting position with the arm in extension and abduction. Following sterile skin preparation, a SHAC block will be performed by the same anaesthesiologist under ultrasound guidance by visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia and glenohumeral pericapsular space. A 22-gauge 50-mm insulated stimulating needle (StimuPlex Nanoline, Braun) will be used to give 1-3 mL of 5% Dextrose for the correct location and then 15 mL local anesthetic solution will be divided into 7,5 mL (0.375 % bupivacaine 5 mL and 2 % lidocaine 2,5 mL) for each target points as interfascial space and pericapsular space.

Group Type: EXPERIMENTAL

Shoulder anterior capsular block

Intervention Type: PROCEDURE

Preoperative ultrasound-guided shoulder anterior capsular(SHAC) block application

Interventions

Interscalene brachial plexus block

Preoperative ultrasound-guided interscalene brachial plexus block application

Intervention Type: PROCEDURE

Shoulder anterior capsular block

Preoperative ultrasound-guided shoulder anterior capsular(SHAC) block application

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who have been diagnosed with rotator cuff rupture and admitted to receiving arthroscopic cuff repair surgery
• American Society of Anaesthesiologists (ASA) Physical Status classification I to III
• Patients who will give informed consent to peripheral nerve blocks

Exclusion Criteria

• Refusal to participate in the study
• History of neurologic deficits or neuropathy affecting the brachial plexus
• Infection at the site of the block application
• Coagulopathy
• Pre-existing respiratory dysfunction
• Allergy to local anesthetics
• Uncooperated patients who cannot reliably answer verbal pain evaluation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haseki Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Berna Caliskan, MD

Role: PRINCIPAL_INVESTIGATOR

Haseki Training and Research Hospital Anesthesiology and Reanimation Department

Locations

Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Berna Caliskan, MD

Role: CONTACT

caliskan.b@gmail.com

+905067108770

Facility Contacts

Berna Caliskan, MD

Role: primary

caliskan.b@gmail.com

+905067108770

References

Yamak Altinpulluk E, Teles AS, Galluccio F, Simon DG, Olea MS, Salazar C, Fajardo Perez M. Pericapsular nerve group block for postoperative shoulder pain: A cadaveric radiological evaluation. J Clin Anesth. 2020 Dec;67:110058. doi: 10.1016/j.jclinane.2020.110058. Epub 2020 Sep 26. No abstract available.

Reference Type: BACKGROUND

PMID: 32987232 (View on PubMed)

Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. doi: 10.1097/ALN.0000000000002919.

Reference Type: BACKGROUND

PMID: 31490292 (View on PubMed)

Other Identifiers

142-2022

Identifier Type: -

Identifier Source: org_study_id