Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04328558

Clavipectoral Fascia Plane Block for Clavicle Surgery

The Effectiveness of Clavipectoral Fascia Plane Block for Analgesia After Clavicle Surgery: Randomized, Prospective Study

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Medipol University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. CPB may be an alternative to interscalene brachial plexus block. The aim of this study is to evaluate the efficacy of the US-guided CPB for postoperative analgesia management compare to no intervention control group after clavicle surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Detailed description

Clavicle fracture is common in men and children after a direct fall on shoulder during sport activity such as cycling or an injury during a traffic accident. The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). 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 The aim of this study is to evaluate the efficacy of the US-guided CPB for postoperative analgesia management compare to no intervention control group after clavicle surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Conditions

Interventions

TypeNameDescription
OTHERClavipectoral fascia plane block groupPatients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

Timeline

Start date
2020-04-22
Primary completion
2021-12-20
Completion
2021-12-30
First posted
2020-03-31
Last updated
2022-04-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04328558. Inclusion in this directory is not an endorsement.