Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mammary Cancer

Intervention / Treatment
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* Device: catheter
* Drug: iv analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iv analgesia<br>patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy. | Device: catheter<br>* 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<br>Drug: iv analgesia<br>* patients were given 100 ml of tramadol 30 minutes before extubation<br>|
| Active Comparator: catheter group<br>patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia | Device: catheter<br>* 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<br>Drug: iv analgesia<br>* patients were given 100 ml of tramadol 30 minutes before extubation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative analgsia, peripheral block catheter, modified radical mastectomy