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Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT03204708
Collaborator
(none)
86
Enrollment
2
Arms
10.5
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: catheter
  • Drug: iv analgesia
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Postoperative Analgesic Efficacy of Catheter Placed Interpectoral Region Via Open Technique in Patients Undergoing Modified Radical Mastectomy
Actual Study Start Date :
Apr 15, 2016
Actual Primary Completion Date :
Feb 15, 2017
Actual Study Completion Date :
Feb 28, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. VAS scores [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 [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 [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 [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 Outcome Measures

  1. VAS scores [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 Outcome Measures

  1. rescue analgesic requirement [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Istanbul University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guniz M.Koksal, professor, Istanbul University
ClinicalTrials.gov Identifier:
NCT03204708
Other Study ID Numbers:
  • 88931902-604.01.01
First Posted:
Jul 2, 2017
Last Update Posted:
Feb 13, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guniz M.Koksal, professor, Istanbul University
postoperative analgsia
peripheral block catheter
modified radical mastectomy
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Feb 13, 2018