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Clinical Trial Summary

The purpose of this study was to investigate the effect of 'muscle sparing technique' while harvesting costal/rib cartilage on postoperative donor-site morbidity -namely postoperative pain. Although authors report 'muscle sparing technique' cause less pain its not investigated in an evidence-based-medicine perspective. Therefore the investigators are planning a controlled, prospective clinical trial to compare the conventional method and 'muscle sparing technique'.

Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial


Clinical Trial Description

Revision rhinoplasty patients requiring costal cartilage were enrolled in the study. All costal cartilage harvestings were full-thickness and they were carried out by a single-surgeon (Berke Ozucer). Patients were randomly assigned either to 'Conservative Muscle-cuttingHarvesting Technique' or 'Muscle-sparing Harvesting Technique'.

Surgical technique costal cartilage harvesting in both groups were identical expect this:

M-Cutting group : Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were cut with Monopolar electrocautery at (25 watts).

M-Sparing group: : Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were passed with blunt dissection. Muscle fibers were dissected parallel to their positioning.

Postoperative pain was evaluated with a Visual Analogue Scale. Participants were questioned regarding their donor-site pain and asked to score their pain 0 (minimum and 10 (maximum). Passive state and pain while active was evaluated separately. This evaluation was carried out at 6th postoperative hour, first, second, third postoperative-days, first postoperative week, on 15th ,30th and 45th day postoperatively. Also postoperative need for analgesics were also noted for the first three days.

Muscle-cutting and muscle-sparing groups were analysed for mean ± Standard deviation values. These values were compared statistically to assess whether muscle-sparing technique has a significant effect on reduced postoperative pain. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02818634
Study type Interventional
Source Gaziosmanpasa Taksim Research and Education Hospital
Contact Berke Ozucer, MD
Phone 905309635939
Email berkeozucer@gmail.com
Status Recruiting
Phase N/A
Start date February 2016
Completion date August 2016

See also
  Status Clinical Trial Phase
Completed NCT02626585 - The Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping N/A