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

• Sponsor: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04990700
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Iatrogenic Injury; Post-thoracotomy Pain Syndrome	Procedure: Partial rib resection	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Clinical data of intervention group and control groups will be comparedClinical data of intervention group and control groups will be compared
• Masking: Single (Participant)
• Masking Description: Patients do not know which study group they are in. The researchers know which group the patients are in.
• Primary Purpose: Prevention
• Official Title: Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain: A Randomized Prospective Study
• Actual Study Start Date: May 9, 2019
• Actual Primary Completion Date: Oct 27, 2020
• Actual Study Completion Date: Nov 27, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Postoperative visual analog scale scores [7 days]

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

Secondary Outcome Measures

1. Iatrogenic rib fractures [During operation]

   Yes or no

2. Administered analgesic doses [Up to 4 weeks]

   Milligram

3. Duration of drainage [Up to 4 weeks]

   Days

4. Length of hospital stay [Up to 4 weeks]

   Days

5. Number of participants with postoperative bronchopulmonary complications [Up to 4 weeks]

   Yes or no

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital	Istanbul		Turkey	34668

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007. Review.
• 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.
• 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.
• Soto RG, Fu ES. Acute pain management for patients undergoing thoracotomy. Ann Thorac Surg. 2003 Apr;75(4):1349-57. Review.
• 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.

• Responsible Party: İsmail Dal, Principal Investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04990700
• Other Study ID Numbers: SiyamiErsek
• First Posted: Aug 4, 2021
• Last Update Posted: Aug 4, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by İsmail Dal, Principal Investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: Post thoracotomy pain; Iatrogenic rib fracture; Thoracotomy; Partial rib resection
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Aug 4, 2021