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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04990700
Other study ID # SiyamiErsek
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 9, 2019
Est. completion date November 27, 2020

Study information

Verified date July 2021
Source Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of partial rib resection in reducing acute post-thoracotomy pain


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date November 27, 2020
Est. primary completion date October 27, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Procedure:
Partial rib resection
1 cm partial rib resection during thoracotomy opening

Locations

Country Name City State
Turkey Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007. Review. — View 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. — View 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. — View Citation

Soto RG, Fu ES. Acute pain management for patients undergoing thoracotomy. Ann Thorac Surg. 2003 Apr;75(4):1349-57. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative visual analog scale scores Min:1, Max:10 points, Higher scores mean worse outcome 7 days
Secondary Iatrogenic rib fractures Yes or no During operation
Secondary Administered analgesic doses Milligram Up to 4 weeks
Secondary Duration of drainage Days Up to 4 weeks
Secondary Length of hospital stay Days Up to 4 weeks
Secondary Number of participants with postoperative bronchopulmonary complications Yes or no Up to 4 weeks
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