Comparison Between Interscalene and Combined Costoclavicular-suprascapular Blocks for Arthroscopic Shoulder Surgery

Regional Anesthesia Morbidity Clinical Trial

Official title:

Comparison Between Interscalene and Combined Costoclavicular-suprascapular Blocks for Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224766
• Other study ID #: 17200124
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to a costoclavicular block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks. This prospective observational study will evaluate the patient response to surgical stimuli and the opioid requirements intraoperatively in patients undergoing shoulder arthroscopies with either a supraclavicular and costoclavicular blocks or an interscalene block. Study Design: Prospective, randomized open label non-inferiority trial. Subject Population: Adults scheduled to undergo elective shoulder arthroscopy Sample Size: 50 patients Study Duration: Starts February 2020 - Ends February 2021 - Interim analysis at 30 patients Study Center: Assuit university hospital

Description:

The main hypothesis of this study is that the suprascapular block combined with a costoclavicular block is not inferior to the interscalene brachial plexus block in terms of postoperative analgesia. Inverstigators postulate that postoperative pain score will not differ significantly in patients who receive either block. secondary objectives will consist in looking at the differences in intraoperative anesthetic consumption, postoperative opioid consumption, arm motor block, diaphragmatic paresis, patient satisfaction and time for readiness to discharge from PACU. investigators hypothesize that these outcomes will be similar in both groups, with the exception of a potential reduction in arm motor block and diaphragmatic paresis in the combined suprascapular and costoclavicular block group. After having obtained institutional ethics board approval of the study, patients older than 18 years old, scheduled for a first elective shoulder arthroscopy under general anesthesia will be screened in the pre-anesthesia clinic. patients will be approached and the whole study procedures will be explained extensively. Interested patients will be invited to sign the consent form .Patients will have the right to opt out at any time. The investigators will meet the patients again on the morning of the surgery to address any concerns. After consent, a study number will be allocated to the patient in ascending order. Two groups will be evaluated: - Group A: single shot US-guided suprascapular nerve block with 5 mL bupivacaine 0.5%, then single shot US-guided costoclavicular block with 10 ml bupivacaine 0.5%. - Group B: single shot US-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5%. Tests will be done to evaluate the nerve block-induced loss of sensation to ice prior to entering the operating room (OR). Diaphragmatic excursion will be evaluated using an abdominal curvilinear ultrasound probe, and will be classified as being normal, paradoxical or immobile. Normal motion is caudad movement during inspiration. Paradoxical motion is cephalad movement during inspiration. Once in the operating room, all routine monitors are connected.. Both study monitors are switched on and will record their respective indices continuously for the duration of the anesthesia. General anesthesia will be induced with propofol (1-2 mg/kg IV), fentanil (1 µg/kg IV bolus) and cis-atracium (0.1-0.2 mg/kg IV; ). A bolus of dexamethasone 4mg IV will be administered after induction of general anesthesia. Patients will also have received oral acetaminophen 1g preoperatively. Intubation with an endotracheal tube is performed once the patient is adequately paralyzed . All drugs are given according to the adjusted body weight of the patient. This is calculated with Robinson's formula: where TBW is total body weight and IBW is ideal body weight (21-22). Immediately after intubation, anesthesia is maintained with isoflurane . At the end of anesthesia, Emergence and extubation are done in the OR. All times (start skin closure, start dressing, stop isoflurane) will be precisely reported in the CRF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

ASA status 1,2,3.

• Age 18 years or older
• Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively

Exclusion Criteria:

• Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
• Coagulation disorders.
• Patient refusal.
• Anatomical disorders and/or neuropathic disease.
• BMI above 40.
• History of substance abuse.
• Chronic use of psychotropic and/or opioid.
• History of psychiatric diseases needing treatment.
• Contraindications to nerve block for shoulder surgery.
• Allergy to fentanil or any drug in the study protocol.
• Failure of nerve block

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity
• Shoulder Surgery

Intervention

Procedure:
• Suprascapular Nerve Block with 5ml bupivicaine 0.5%
The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the proximal suprascapular nerve is visualized before it turns toward the suprascapular notch. It is blocked using 5mL of bupivicaine 0.5%.
• costoclavicular Block 10ml bupivicaine 0.5%
transverse ultrasound imaging of the medial infraclavicular fossa to identify the cords of the brachial plexus at the costoclavicular space (CCS) then inject 10ml bupivicaine 0.5%
• Interscalene Brachial Plexus Block 15ml bupivicaine 0.5%
The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the interscalene groove is visualized along with the roots of the brachial plexus. The block is performed with 15mL of bupivacaine 0.5%.

Locations

Country	Name	City	State
Egypt	Assuit University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scores on a scale from 0 to 10	PACU pain score from 1 to 10 which 1 indicate no pain and 10 maximum pain.	From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum
Primary	naluphine consumption postoperative	use of naluphine for postoperative analgesia in mg by asking PACU nurse questionnaire	2 hours postoperative
Secondary	Total dose fentanil in mcg	Total dose of fentanil in mcg from incision until wound dressing	Intraoperative
Secondary	Time to awakening in minutes	Time to awakening in minutes.	Intraoperative
Secondary	Time to extubation in minutes	Time to extubation in minutes.	Intraoperative
Secondary	Patient dyspnea on a scale from 0 to 10 in dyspnea scale	Patient dyspnea prior to PACU discharge on a scale from 0 to 10.	PACU e.g. up to 3 hours after surgery maximum
Secondary	24h pain scores on a scale from 0 to 10 at rest (NPS)	24h pain scores, H24	Postoperative at H24, 24 hours after surgery
Secondary	Duration of motor block in minutes strength	Duration of motor block in minutes, as measured by time to return of normal grip strength.	Postoperative for day 1 H24 24hours after surgery
Secondary	TIME OF 1ST RESCUE ANALGESIC	time of 1st dose of naluphine use postoperative	24 hour postoperative