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OpenTrials
Completed

NCT Number: NCT03204708

Open Technique Interpectoral Catheter for Postoperative Analgesia in 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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

catheter

Device

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

iv analgesia

Drug

patients were given 100 ml of tramadol 30 minutes before extubation

Primary outcomes

  1. VAS scores

    Time frame: 1 hour 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.

  2. VAS scores

    Time frame: 6 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.

  3. VAS scores

    Time frame: 12 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.

  4. VAS scores

    Time frame: 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 outcomes

  1. VAS scores

    Time frame: 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.

Other outcomes

  1. rescue analgesic requirement

    Time frame: 1, 6, 12 and 24 hours after operation

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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2017
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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