NCT05332028

Ultrasound-guided Paravertebral Block Versus Mid-point Transverse Process Pleura Block in Mastectomy Surgery

Completed Phase 4 Last updated 18 April 2022

What this trial tests

Phase 4 trial testing bupivacaine in Mastectomy; Lymphedema in 64 participants. Completed in 20 April 2021.

Timeline

26 March 2020

Primary endpoint
20 April 2021

20 April 2021

Quick facts

Lead sponsor	Ataturk University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	64
Start date	26 March 2020
Primary completion	20 April 2021
Estimated completion	20 April 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• bupivacaine (BUPIVACAINE) — full drug profile →
• 22 gauge 100 mm needle
• Propofol (Propofol) — full drug profile →
• fentanyl (fentanyl) — full drug profile →

Conditions studied

• Mastectomy; Lymphedema — all drugs for Mastectomy; Lymphedema →
• Anesthesia, Local — all drugs for Anesthesia, Local →
• Surgery — all drugs for Surgery →

Sponsor

Ataturk University

Who can join

Adults 18 to 65, female only, with Mastectomy; Lymphedema or Anesthesia, Local. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was performed to analyze the postoperative analgesic effects of the paravertebral block (PVB) and Mid-Point Transverse Process Pleura (MTP) block after a unilateral mastectomy surgery.

This study included 64 women aged 18-65 years, American Society of Anesthesiologists score I-III, who were scheduled for unilateral simple mastectomy operation due to breast cancer. Patients were randomly assigned to Group 1 (Patients undergoing PVB) or Group 2 (Patients undergoing MTP block) for a ratio of 1:1, including 32 patients each, using a computer-generated table of random numbers and concealed sealed opaque envelopes.

Patients were placed in the prone position. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level in Group 1, and the midpoint level between the transverse process and pleura in Group 2, it was observed that there was no blood or air by aspiration. Then, the needle location was confirmed with 0.5-1 mL of saline, and a 20 mL of 0.25% bupivacaine was applied. Thirty minutes after block application, the sensorial block level was evaluated by pinprick test at the midclavicular line, and the blocked dermatome area was recorded as front and back. Complications developed during the process (such as hypotension, vascular injury, local anaesthetic toxicity) were recorded.Routine general anesthesia protocol was performed to all patients.At the end of the surgery, neuromuscular block antagonization was performed with 4 mg/kg sugammadex. All of the patients were extubated and taken to the postanesthetic care unit (PACU). In the PACU, a patient-controlled analgesia device (PCA) containing fentanyl was administered.

Time to the first request for analgesia, postoperative fentanyl consumption, and VAS score values at rest and in motion at postoperative 1, 4, 8, 12, 16, 20 and 24 hours, the duration of block implementation and the duration of surgery were recorded.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Comparison of Postoperative Analgesic Efficacy of Ultrasound-Guided Paravertebral Block and Mid-Point Transverse Process Pleura Block in Mastectomy Surgeries: A Randomized Study.
   Kahramanlar AA, Aksoy M, Ince I, Dostbıl A, et al · · 2022 · cited 14× · PMID 35848451 · DOI 10.1080/08941939.2022.2098544