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

NCT ID: NCT04990700

Last Updated: 2021-08-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-09

Study Completion Date

2020-11-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain, Postoperative Iatrogenic Injury Post-thoracotomy Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Clinical data of intervention group and control groups will be compared
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Patients do not know which study group they are in. The researchers know which group the patients are in.

Study Groups

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Control Group

Includes patients undergoing routine thoracotomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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

Group Type EXPERIMENTAL

Partial rib resection

Intervention Type PROCEDURE

1 cm partial rib resection during thoracotomy opening

Interventions

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Partial rib resection

1 cm partial rib resection during thoracotomy opening

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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İsmail Dal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İsmail Dal, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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

Reference Type BACKGROUND
PMID: 18456219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1093513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8722735 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12683601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19954996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30993532 (View on PubMed)

Other Identifiers

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SiyamiErsek

Identifier Type: -

Identifier Source: org_study_id

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