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

NCT04990700 | Completed

• 1 other identifier: SiyamiErsek
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Post thoracotomy pain; Iatrogenic rib fracture; Thoracotomy; Partial rib resection

Outcome Measures

Primary Outcomes (1)

• Postoperative visual analog scale scores

  Min:1, Max:10 points, Higher scores mean worse outcome

  7 days

Secondary Outcomes (5)

• Iatrogenic rib fractures

  During operation

• Administered analgesic doses

  Up to 4 weeks

• Duration of drainage

  Up to 4 weeks

• Length of hospital stay

  Up to 4 weeks

• Number of participants with postoperative bronchopulmonary complications

  Up to 4 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Includes patients undergoing routine thoracotomy

Intervention Group

EXPERIMENTAL

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

Procedure: Partial rib resection

Interventions

Partial rib resection PROCEDURE

1 cm partial rib resection during thoracotomy opening

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (6)

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

  PMID: 18456219 BACKGROUND

• 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.

  PMID: 1093513 BACKGROUND

• 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.

  PMID: 8722735 BACKGROUND

• 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.

  PMID: 12683601 BACKGROUND

• 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.

  PMID: 19954996 BACKGROUND

• 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.

  PMID: 30993532 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• İsmail Dal, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients do not know which study group they are in. The researchers know which group the patients are in.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Clinical data of intervention group and control groups will be compared

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 4, 2021
• Study Start: May 9, 2019
• Primary Completion: October 27, 2020
• Study Completion: November 27, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)