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

NCT ID: NCT02818634

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Nasal Deformity Revision Rhinoplasty Autogenous Rib Graft Costal Cartilage Harvesting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Muscle-sparing

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.

Group Type ACTIVE_COMPARATOR

Harvesting rib cartilage

Intervention Type PROCEDURE

Muscle-cutting

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).

Group Type ACTIVE_COMPARATOR

Harvesting rib cartilage

Intervention Type PROCEDURE

Interventions

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Harvesting rib cartilage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Revision rhinoplasty
* when costal cartilage is harvested full-thickness

Exclusion Criteria

* Fibromyalgia
* No consent
* When patient does not comply with follow-up
Minimum Eligible Age

17 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Berke Ozucer

MD, Otolaryngologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berke Ozucer, MD

Role: STUDY_DIRECTOR

Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment

Mehmet E Dinc, MD

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment

Locations

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Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology

Istanbul, Gaziosmanpasa, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Berke Ozucer, MD

Role: CONTACT

Phone: 905309635939

Email: [email protected]

Mehmet E Dinc, MD

Role: CONTACT

Phone: 905065426492

Email: [email protected]

Facility Contacts

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Berke Ozucer, MD

Role: primary

Emre M Dinc, MD

Role: backup

References

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Fedok FG. Costal Cartilage Grafts in Rhinoplasty. Clin Plast Surg. 2016 Jan;43(1):201-12. doi: 10.1016/j.cps.2015.08.002. Epub 2015 Oct 24.

Reference Type BACKGROUND
PMID: 26616708 (View on PubMed)

Cochran CS. Harvesting Rib Cartilage in Primary and Secondary Rhinoplasty. Clin Plast Surg. 2016 Jan;43(1):195-200. doi: 10.1016/j.cps.2015.09.018. Epub 2015 Oct 23.

Reference Type BACKGROUND
PMID: 26616707 (View on PubMed)

Other Identifiers

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COSTA

Identifier Type: -

Identifier Source: org_study_id