Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy

Evaluation of the Postoperative Analgesic Efficacy of Catheter Placed Interpectoral Region Via Open Technique in Patients Undergoing Modified Radical Mastectomy

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.

Study Overview

• Status: Completed
• Conditions: Mammary Cancer
• Intervention / Treatment: Device: catheter; Drug: iv analgesia

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iv analgesia; patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.	Device: catheter; catheter was placed under clavipectoral fascia by open technique by surgeon at the 1/3 lateral part of clavicula neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis; Drug: iv analgesia; patients were given 100 ml of tramadol 30 minutes before extubation
Active Comparator: catheter group; patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia	Device: catheter; catheter was placed under clavipectoral fascia by open technique by surgeon at the 1/3 lateral part of clavicula neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis; Drug: iv analgesia; patients were given 100 ml of tramadol 30 minutes before extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS scores	patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.	1 hour after operation
VAS scores	patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.	6 hours after operation
VAS scores	patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.	12 hours after operation
VAS scores	patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.	24 hours after operation

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
rescue analgesic requirement	patients whose VAS scores were over 4 were given 50 mg of dexketoprofen in Group I, 10 ml %0.25 bupivacain in Group II	1, 6, 12 and 24 hours after operation

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: cigdem akyol beyoglu, MD, Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2016
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: postoperative analgsia; peripheral block catheter; modified radical mastectomy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 88931902-604.01.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No