Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy

Not Applicable

Completed

• Conditions: Mammary Cancer
• Interventions: Device: catheter; Drug: iv analgesia

• Registration Number: NCT03204708
• Lead Sponsor: Istanbul University

Brief Summary

patients undergoing modified radical mastectomy were divided into two groups. patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.

Detailed Description

patients undergoing modified radical mastectomy were divided into two groups by computer. patients in catheter group were placed a catheter under clavipectoral fascia in the neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis at the 1/3 lateral part of clavicula. solution included 10 ml of %0.5 bupivacain, %1 lidocain, 10 ml %0.9 sodium chloride totally 30 ml were given via the catheter for postoperative analgesia at the end of surgery. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. Patients in both groups were given dexketoprofen 50 mg iv if the VAS score was over 4. VAS scores, rescue analgesic requirement and timing, complications were recorded and compared between groups 1, 6, 12, 24 hours and 90 days after surgery.

Study Timeline

• Study Start: 2016-04-15
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-28
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-07-02
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• American Society of Americans Class I-II

Exclusion Criteria

• male
• allergy to local anesthetics or
• anticoagulant drug use
• central or peripheric nerve disease
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
catheter group	catheter	patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia
iv analgesia	catheter	patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.
iv analgesia	iv analgesia	patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.
catheter group	iv analgesia	patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia

Primary Outcome Measures

Name	Time	Method
VAS scores	24 hours after operation	patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

Secondary Outcome Measures

Name	Time	Method
VAS scores	3 months after operation	patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.