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Trials / Completed

CompletedNCT04297007

Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

Comparison of Ultrasound-Guided Type-II Pectoral Nerve Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

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

Summary

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs. It has been reported that RIB may provide effective analgesia management for several breast surgeries. The primary aim of the study 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

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced. Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. It is easy to perform; under ultrasound (US) guidance, the interfascial region between the pectoral muscles (pectoralis major (PMm) and minor (Pmm), serratus anterior Sam) is injected with local anaesthetics. It has been reported that PECS type-2 block provides effective analgesia management for mastectomy and axillary dissection surgeries. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several breast surgeries. The aim of this study is to evaluate the efficacy of the US-guided PECS-II and RIB for postoperative analgesia management compare to no intervention control group after mastectomy and axillary dissection 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
OTHERPECS blockA dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients 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.
OTHERRhomboid intercostal blockA dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients 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
2020-03-23
Primary completion
2021-01-20
Completion
2021-02-20
First posted
2020-03-05
Last updated
2021-04-02

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04297007. Inclusion in this directory is not an endorsement.