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Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy

Primary Purpose

Mammary Cancer

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

catheter

iv analgesia

About this trial

This is an interventional supportive care trial for Mammary Cancer focused on measuring postoperative analgsia, peripheral block catheter, modified radical mastectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

iv analgesia

catheter group

Arm Description

patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.

patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03204708

First Posted

May 22, 2017

Last Updated

February 12, 2018

Sponsor

Istanbul University

1. Study Identification

Unique Protocol Identification Number

NCT03204708

Brief Title

Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

April 15, 2016 (Actual)

Primary Completion Date

February 15, 2017 (Actual)

Study Completion Date

February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mammary Cancer

Keywords

postoperative analgsia, peripheral block catheter, modified radical mastectomy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

iv analgesia

Arm Type

Active Comparator

Arm Description

patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy.

Arm Title

catheter group

Arm Type

Active Comparator

Arm Description

patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia

Intervention Type

Device

Intervention Name(s)

catheter

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

iv analgesia

Intervention Description

patients were given 100 ml of tramadol 30 minutes before extubation

Primary Outcome Measure Information:

Title

VAS scores

Description

patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

Time Frame

1 hour after operation

Title

VAS scores

Description

patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

Time Frame

6 hours after operation

Title

VAS scores

Description

patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

Time Frame

12 hours after operation

Title

VAS scores

Description

patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

Time Frame

24 hours after operation

Secondary Outcome Measure Information:

Title

VAS scores

Description

patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.

Time Frame

3 months after operation

Other Pre-specified Outcome Measures:

Title

rescue analgesic requirement

Description

patients whose VAS scores were over 4 were given 50 mg of dexketoprofen in Group I, 10 ml %0.25 bupivacain in Group II

Time Frame

1, 6, 12 and 24 hours after operation

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

breast cancer

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

cigdem akyol beyoglu, MD

Organizational Affiliation

Istanbul University

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy

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