Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy

Mammary Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204708
• Other study ID #: 88931902-604.01.01
• Status: Completed
• Phase: N/A
• First received: May 22, 2017
• Last updated: February 12, 2018
• Start date: April 15, 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: February 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 28, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Mammary Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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