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

Pain, Postoperative Clinical Trial

Official title:

Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain: A Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990700
• Other study ID #: SiyamiErsek
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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