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

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Post-thoracotomy Pain Syndrome; Iatrogenic Injury
• Intervention / Treatment: Procedure: Partial rib resection

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34668
    • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Includes patients undergoing routine thoracotomy
Experimental: Intervention Group; The group that will undergo 1 cm partial rib resection during thoracotomy.	Procedure: Partial rib resection; 1 cm partial rib resection during thoracotomy opening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative visual analog scale scores	Min:1, Max:10 points, Higher scores mean worse outcome	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iatrogenic rib fractures	Yes or no	During operation
Administered analgesic doses	Milligram	Up to 4 weeks
Duration of drainage	Days	Up to 4 weeks
Length of hospital stay	Days	Up to 4 weeks
Number of participants with postoperative bronchopulmonary complications	Yes or no	Up to 4 weeks

Collaborators and Investigators

• Sponsor: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
• Investigators: Principal Investigator: İsmail Dal, PhD, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): October 27, 2020
• Study Completion (Actual): November 27, 2020

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Thoracotomy; Post thoracotomy pain; Iatrogenic rib fracture; Partial rib resection
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SiyamiErsek

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No