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Completed

NCT Number: NCT05268874

The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery

Clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. In the literature, data about CPB is so limited, however it seems a good option for pain management after clavicle fracture.

The aim of this study is to evaluate the efficacy of the ultrasound-guided CPB for postoperative analgesia management and patient satisfaction in patients underwent clavicle surgery.

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Key information

Conditions

Clavicle Fracture Clavicle Injury

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mugla Sıtkı Kocman University Hospital

Muğla, Turkey (Türkiye)

About this study

Clavipectoral fascia plane block (CPB) was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. The clavipectoral fascia covers the clavicular site of the pectoralis major muscle. It provides the potential interfascial space between the clavicle and the pectoralis major muscle. CPB provide effective analgesia after clavicle surgery. It is also easy to perform. With this advantage and its analgesic effectiveness for clavicle surgery, CPB may be an alternative to interscalene brachial plexus block. However, randomized clinical efficacy trials are needed to investigate the effectiveness of CPB for clavicle fractures. In the literature, data about CPB is so limited, however it seems a good alternative to brachial plexus block for pain management after clavicle fracture

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for clavicle surgery under general anesthesia

Exclusion criteria

  • bleeding diathesis,
  • anticoagulation,
  • thorax wall abnormalities
  • study drug allergy,
  • infection at the block area,
  • pregnancy or lactation,
  • patients who do not accept the procedure

Treatment and study plan

Clavipectoral block

Other

Clavipectoral block will be performed with patients in the supine position. The probe will be placed on the anterior border of the medial third (or on the proximal or distal end, according to the localization of the fracture) of the clavicle. A 22-gauge, 50 mm block needle will be inserted in a caudal to cephalic direction, the periosteum of the clavicle and the surrounding fascia will be visualized, 30 ml of 0.25% bupivacaine will be injected between these two layers. The local anesthetic spread to medial and lateral third of the clavicle will be seen.

Primary outcomes

  1. Postoperative pain scores (NRS)

    Time frame: Postoperative 24 hours period

    The primary outcome is the NRS at postoperative 8th hour

Secondary outcomes

  1. The use of rescue analgesia (number of participants and rate of tramodol using)

    Time frame: Postoperative 24 hours period

    Tramodol using

  2. Patient satisfaction

    Time frame: Postoperative at 24th hour

    Patient satisfaction will be evaluated with seven item Likert scala

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

The Effect of Clavipectoral Fascia Plane Block on Pain Management and Patient Satisfaction Following Clavicle Surgery: Randomized, Prospective Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 7, 2022
Registry last updated
Sep 19, 2022

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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