Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03204708

Enrollment

Registered

2017-07-02

Start date

2016-04-15

Completion date

2017-02-28

Last updated

2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mammary Cancer

Keywords

postoperative analgsia, peripheral block catheter, modified radical mastectomy

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.

Interventions

DEVICEcatheter

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

DRUGiv analgesia

patients were given 100 ml of tramadol 30 minutes before extubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026