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Completed

NCT Number: NCT05646667

Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia

The aim of this study is to compare the effectiveness of interscalene brachial plexus block alone versus interscalene brachial plexus block +Erector spinae plane block in anesthesia for shoulder arthroscopy.

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Key information

Conditions

Interscalene Block Erector Spinae Plane Block Randomized Controlled Trial Shoulder Arthroscopy Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Islam Morsy

Tanta, Egypt

About this study

Regional anesthetic techniques can control pain effectively, both at rest and on movement, allowing earlier mobilization without the adverse effects of opioids . Among the various types of regional anesthetic techniques, the interscalene brachial plexus block is a gold standard used nerve block technique for postoperative analgesia in patients undergoing shoulder surgery, as it has consistently been shown to significantly control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-65 years
  • Both genders,
  • BMI < 40 kg/m2
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective shoulder arthroscopy.

Exclusion criteria

  • Known allergy to local anesthetics,
  • allergy to all opioid medications, diagnostic shoulder arthroscopic procedures,
  • patients with chronic opioids,
  • patients who converted to general anesthesia use and coagulopathy

Treatment and study plan

interscalene with Erector spinae plane block group

Other

patients will receive interscalene brachial plexus block using 10 ml of bupivacaine 0.5% and US guided Erector spinae plane block at T2 using 10 ml of bupivacaine 0.5%.

Interscalene group

Other

patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5%.

Primary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: Intraoperative up to 4 hours

    If the patient complains of pain during surgery, fentanyl will be administered 1 µg/kg IV increments.

Secondary outcomes

  1. Amount of 24hrs postoperative rescue analgesic consumption

    Time frame: 24 hours postoperatively

    Intravenous meperidine (0.5 mg/kg) will be administered if numerical pain rating scale (NRS) score of more than 3.

  2. Degree of pain by Numerical pain rating scale

    Time frame: 24 hours postoperatively

    Postoperative pain (using NRS at admission) will be measured at PACU, 1h, 2hr. 4hr, 6hr, 8hr, 12hr, 18hr, and 24hrs postoperative. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

  3. Time to first request of rescue analgesia.

    Time frame: 24 hours postoperatively

    Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS >3. Time to the 1st rescue analgesic request will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2022
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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