Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

Sponsor

University of Chile (Other)

Overall Status

Completed

CT.gov ID

NCT03224884

Collaborator

(none)

Enrollment

Location

Arms

3.1

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease.

This randomized controlled trial will compare ultrasound-guided interscalene block (ISB) and supraclavicular block in patients undergoing arthroscopic shoulder surgery.

The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10.

Our research hypothesis is that interscalene and supraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Shoulder Pain Surgical Procedure, Unspecified Diaphragmatic Paralysis	Procedure: Interscalene block Procedure: Supraclavicular block	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

A Randomized Comparison Between Interscalene and Supraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery

Actual Study Start Date :

Jul 24, 2017

Actual Primary Completion Date :

Oct 25, 2017

Actual Study Completion Date :

Oct 25, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interscalene block Patients randomized to receive an interscalene block .	Procedure: Interscalene block Ultrasound guided brachial plexus block injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in the interscalene groove, under the prevertebral fascia.
Experimental: Supraclavicular block Patients randomized to receive a supraclavicular block.	Procedure: Supraclavicular block Ultrasound guided brachial plexus injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL (3 mL in the "corner pocket" followed by 17 mL posterolateral to the brachial plexus).

Arm

Intervention/Treatment

Active Comparator: Interscalene block

Patients randomized to receive an interscalene block .

Procedure: Interscalene block

Ultrasound guided brachial plexus block injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in the interscalene groove, under the prevertebral fascia.

Experimental: Supraclavicular block

Patients randomized to receive a supraclavicular block.

Procedure: Supraclavicular block

Ultrasound guided brachial plexus injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL (3 mL in the "corner pocket" followed by 17 mL posterolateral to the brachial plexus).

Outcome Measures

Primary Outcome Measures

Static pain at 30 minutes after arrival in the PACU [30 minutes]
Evaluated with a NRS from 0 to 10.

Secondary Outcome Measures

Static pain at 60 minutes after arrival in the PACU [60 minutes]
Evaluated with a NRS from 0 to 10.
Postoperative static pain at 2 hours [2 hours]
Evaluated with a NRS from 0 to 10.
Postoperative static pain at 3 hours [3 hours]
Evaluated with a NRS from 0 to 10.
Postoperative static pain at 6 hours [6 hours]
Evaluated with a NRS from 0 to 10.
Postoperative static pain at 12 hours [12 hours]
Evaluated with a NRS from 0 to 10.
Postoperative static pain at 24 hours [24 hours]
Evaluated with a NRS from 0 to 10.
Incidence of HDP at 30 minutes after interscalene or supraclavicular block [30 minutes post injection]
Ultrasound diagnosed HDP
Incidence of HDP at 30 minutes after arrival to PACU. [30 minutes after arrival to PACU]
Ultrasound diagnosed HDP
Block performance time [1 hour before surgery]
Time from skin desinfection until the end of local anesthetic injection.
Sensory and Motor block [30 minutes post injection]
Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score.
Incidence of complete block [30 minutes post injection]
Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection.
Procedural pain during blocks [1 hour before surgery]
Evaluated with a NRS from 0 to 10.
Onset time [1 hour before surgery]
Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points.
Intraoperative opioid requirements [Intraoperative period]
Total amount of fentanyl required during general anesthesia.
Surgical duration [intraoperative period]
Time between skin incision and closure.
Postoperative opioid consumption [24 hours after surgery]
Total amount of morphine required during the first 24 hours after surgery.
Patient satisfaction [24 hours after surgery]
Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 = very satisfied).
Block- and opioid-related side effects [1 week]
Incidence of side effects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing arthroscopic shoulder surgery
American Society of Anesthesiologists classification 1-3
Body mass index between 20 and 35

Exclusion Criteria:

Adults who are unable to give their own consent
Pre-existing neuropathy
Coagulopathy
Obstructive or restrictive pulmonary disease
Renal failure
Hepatic failure
Allergy to local anesthetics
Pregnancy
Prior surgery in the corresponding side of the neck or supraclavicular fossa
Chronic pain syndromes requiring opioid intake at home

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinico Universidad de Chile	Santiago	Metropolitan	Chile	8380456

Sponsors and Collaborators

University of Chile

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Julian Aliste, Clinical Instructor, University of Chile

ClinicalTrials.gov Identifier:

NCT03224884

Other Study ID Numbers:

888/17

First Posted:

Jul 21, 2017

Last Update Posted:

Nov 14, 2017

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shoulder Pain

Respiratory Paralysis

Paralysis

Pain, Postoperative

Study Results

No Results Posted as of Nov 14, 2017