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Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain

Primary Purpose

Pain, Postoperative, Iatrogenic Injury, Post-thoracotomy Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Partial rib resection
Sponsored by
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Post thoracotomy pain, Iatrogenic rib fracture, Thoracotomy, Partial rib resection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants who underwent thoracotomy in our clinic in 2019-2020
  • Participants signing an informed consent form

Exclusion Criteria:

  • Thoracic wall tumor
  • Invasion of the thoracic wall by extrathoracic malignancy
  • Pleural pathology
  • History of previous rib fracture
  • History of previous thoracotomy
  • History of thoracic radiotherapy
  • Emergency surgery
  • Simultaneous incisions other than thoracotomy

Sites / Locations

  • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Includes patients undergoing routine thoracotomy

The group that will undergo 1 cm partial rib resection during thoracotomy.

Outcomes

Primary Outcome Measures

Postoperative visual analog scale scores
Min:1, Max:10 points, Higher scores mean worse outcome

Secondary Outcome Measures

Iatrogenic rib fractures
Yes or no
Administered analgesic doses
Milligram
Duration of drainage
Days
Length of hospital stay
Days
Number of participants with postoperative bronchopulmonary complications
Yes or no

Full Information

First Posted
July 16, 2021
Last Updated
July 27, 2021
Sponsor
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04990700
Brief Title
Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain
Official Title
Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain: A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
October 27, 2020 (Actual)
Study Completion Date
November 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the effect of partial rib resection in reducing acute post-thoracotomy pain
Detailed Description
It is known that severe post thoracotomy pain can be reduced by half with some strategies to prevent pain development. It was thought that partial rib resection would reduce intercostal tension and prevent an uncontrolled fracture. Thus, it is argued that post thoracotomy pain can be reduced. Partial rib resection is applied in clinical practice in selected patient groups. However, we could not find a clinical study on this subject in the English literature. The aim of this study is to determine whether partial rib resection has an effect on the control of thoracotomy pain. Before the thoracotomy incision, simple randomization will be performed by flipping a coin. Routine thoracotomy incision will be performed in the control group. In the intervention group, approximately 1 cm segment of the 6th rib will be excised with a rib scissors before the thorax retractor was placed. Pericostal suture technique will be used in both groups at thoracotomy closure. Demographic information of the cases, preoperative respiratory function parameters, body mass index, Visual Analogue Scale scores, complications and analgesic doses will be recorded in the Case Report Form regularly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Iatrogenic Injury, Post-thoracotomy Pain Syndrome
Keywords
Post thoracotomy pain, Iatrogenic rib fracture, Thoracotomy, Partial rib resection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Clinical data of intervention group and control groups will be compared
Masking
Participant
Masking Description
Patients do not know which study group they are in. The researchers know which group the patients are in.
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Includes patients undergoing routine thoracotomy
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The group that will undergo 1 cm partial rib resection during thoracotomy.
Intervention Type
Procedure
Intervention Name(s)
Partial rib resection
Intervention Description
1 cm partial rib resection during thoracotomy opening
Primary Outcome Measure Information:
Title
Postoperative visual analog scale scores
Description
Min:1, Max:10 points, Higher scores mean worse outcome
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Iatrogenic rib fractures
Description
Yes or no
Time Frame
During operation
Title
Administered analgesic doses
Description
Milligram
Time Frame
Up to 4 weeks
Title
Duration of drainage
Description
Days
Time Frame
Up to 4 weeks
Title
Length of hospital stay
Description
Days
Time Frame
Up to 4 weeks
Title
Number of participants with postoperative bronchopulmonary complications
Description
Yes or no
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants who underwent thoracotomy in our clinic in 2019-2020 Participants signing an informed consent form Exclusion Criteria: Thoracic wall tumor Invasion of the thoracic wall by extrathoracic malignancy Pleural pathology History of previous rib fracture History of previous thoracotomy History of thoracic radiotherapy Emergency surgery Simultaneous incisions other than thoracotomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail Dal, PhD
Organizational Affiliation
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18456219
Citation
Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
Results Reference
background
PubMed Identifier
1093513
Citation
Meyers JR, Lembeck L, O'Kane H, Baue AE. Changes in functional residual capacity of the lung after operation. Arch Surg. 1975 May;110(5):576-83. doi: 10.1001/archsurg.1975.01360110122020.
Results Reference
background
PubMed Identifier
8722735
Citation
Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.
Results Reference
background
PubMed Identifier
12683601
Citation
Soto RG, Fu ES. Acute pain management for patients undergoing thoracotomy. Ann Thorac Surg. 2003 Apr;75(4):1349-57. doi: 10.1016/s0003-4975(02)04647-7.
Results Reference
background
PubMed Identifier
19954996
Citation
Wu N, Yan S, Wang X, Lv C, Wang J, Zheng Q, Feng Y, Yang Y. A prospective, single-blind randomised study on the effect of intercostal nerve protection on early post-thoracotomy pain relief. Eur J Cardiothorac Surg. 2010 Apr;37(4):840-5. doi: 10.1016/j.ejcts.2009.11.004. Epub 2009 Dec 1.
Results Reference
background
PubMed Identifier
30993532
Citation
El-Hag-Aly MA, Hagag MG, Allam HK. If post-thoracotomy pain is the target, Integrated Thoracotomy is the choice. Gen Thorac Cardiovasc Surg. 2019 Nov;67(11):955-961. doi: 10.1007/s11748-019-01126-2. Epub 2019 Apr 16.
Results Reference
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Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain

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