Clinical trial NCT04990700: Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain
Official title: Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Iatrogenic Injury
Post-thoracotomy Pain Syndrome
Keywords: Post thoracotomy pain
Iatrogenic rib fracture
Thoracotomy
Partial rib resection
Lead sponsor: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Clinical data of intervention group and control groups will be compared
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative visual analog scale scores
timeFrame: 7 days
Secondary outcomes:
measure: Iatrogenic rib fractures
timeFrame: During operation
measure: Administered analgesic doses
timeFrame: Up to 4 weeks
measure: Duration of drainage
timeFrame: Up to 4 weeks
measure: Length of hospital stay
timeFrame: Up to 4 weeks
measure: Number of participants with postoperative bronchopulmonary complications
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Study officials:
affiliation: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
name: İsmail Dal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
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. doi: 10.1001/archsurg.1975.01360110122020.
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. doi: 10.1097/00002508-199603000-00009.
citation: 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.
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.
citation: 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.