Does a Multimodal no‐Compression Suture Technique of the Intercostal Space Reduce Chronic Post‐Thoracotomy Pain?

Chronic Postoperative Pain Clinical Trial

Official title:

Does a Multimodal no‐Compression Suture Technique of the Intercostal Space Reduce Chronic Post‐Thoracotomy Pain? A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630849
• Other study ID #: 1222/13
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: December 14, 2015
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: December 2015
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial Summary

Chronic post-thoracotomy pain is a significant adverse outcome of thoracic surgery. transcollation technology evaluated with a prospective randomized trial the effect of a multimodal no-compression suture technique of the intercostal space on postoperative pain occurrence in patients undergoing mini-thoracotomy.

Patients undergoing a muscle-sparing lateral mini-thoracotomy for different thoracic diseases were randomly divided into two groups:one group received intercostal muscle flap harvesting and pericostal no-compression "edge" suture (IMF group), and the second group received a standard suture technique associated with an intrapleural intercostal nerve block (IINB group).

The aim of the study was to demonstrate that the multimodal no-compression suture technique is a rapid and feasible procedure reducing early and chronic post‐thoracotomy pain intensity.

Description:

Patients' data were prospectively recorded in a single database and surgery was performed in a single thoracic center in order to achieve homogenous treatment.

After acceptance from the Ethics Committee of our Institution, a prospective randomized study of 487 patients was performed from October 2011 to October 2013 in the Thoracic Surgery Division - Sant'Andrea Hospital, Faculty of Medicine and Psychology, University of Rome "Sapienza". All patients who were scheduled to undergo a muscle-sparing lateral mini-thoracotomy for different thoracic diseases were eligible for this trial. Exclusion criteria were: history of previous thoracotomy, chronic pain syndrome (any type of pain), opioid/steroid use 6 months before surgery, chest trauma with rib fractures, radiologic evidence of parietal pleural or chest wall tumor invasion, and previous neoadjuvant or radiation therapy.

Preoperative consent was obtained from all patients, informed that they would have one of the two methods of chest closure.

Pulmonary function tests (spirometry and 6-minute walking test [6‐MWT]) were performed in all patients preoperatively and at 1 and 6 months postoperatively. All patients received our standard muscle‐sparing lateral minithoracotomy through the fifth intercostal space without division of the latissimus dorsi muscle and the serratus anterior muscle. The postoperative analgesic protocol was the same for all patients in both groups, and consisted of a continuous intravenous infusion of tramadol (10 mg/h) and ketorolac tromethamine (3 mg/h), starting at the time of surgical skin incision and continuing until 48‐72 h after surgery. Intravenous analgesia was then continued with ketorolac tromethamine (10 mg tid) and paracetamol (1 g tid) until discharge from the hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients who were scheduled to undergo a muscle-sparing lateral mini-thoracotomy for different thoracic diseases were eligible for this trial.

Exclusion Criteria:

• History of previous thoracotomy

• Chronic pain syndrome (any type of pain)

• Opioid/steroid use 6 months before surgery

• Chest trauma with rib fractures

• Radiologic evidence of parietal pleural or chest wall tumor invasion

• Previous neoadjuvant or radiation therapy.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

Intervention

Procedure:
• intercostal muscle flap and pericostal no-compression suture
intercostal muscle flap and pericostal no-compression suture of the intercostal space
• Standard suture technique of the intercostal space
Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

References & Publications (3)

Caraceni A, Mendoza TR, Mencaglia E, Baratella C, Edwards K, Forjaz MJ, Martini C, Serlin RC, de Conno F, Cleeland CS. A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain. 1996 Apr;65(1):87-92. — View Citation

Cerfolio RJ, Bryant AS, Maniscalco LM. A nondivided intercostal muscle flap further reduces pain of thoracotomy: a prospective randomized trial. Ann Thorac Surg. 2008 Jun;85(6):1901-6; discussion 1906-7. doi: 10.1016/j.athoracsur.2008.01.041. — View Citation

D'Andrilli A, Ibrahim M, Ciccone AM, Venuta F, De Giacomo T, Massullo D, Pinto G, Rendina EA. Intrapleural intercostal nerve block associated with mini-thoracotomy improves pain control after major lung resection. Eur J Cardiothorac Surg. 2006 May;29(5):790-4. Epub 2006 Feb 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term Brief Pain Inventory Scale Variation	the aim of the study is to evaluate the variation of the brief pain inventory scale (BPI) in patients treated with a non-divided intercostal muscle flap associated with pericostal "edge" sutures (thus protecting the intercostal nerves from trauma) on long-term versus patients who will receive our standard pain control strategy (intrapleural intercostal nerve block).	6 months after surgery	No
Secondary	Mid term Brief Pain Inventory Scale Variation	the aim of the study is to evaluate the variation of the brief pain inventory scale (BPI) in patients treated with a non-divided intercostal muscle flap associated with pericostal "edge" sutures (thus protecting the intercostal nerves from trauma) after 1 month versus patients who will receive our standard pain control strategy (intrapleural intercostal nerve block).	1 month after surgery	No
Secondary	Pulmonary functional tests	spirometry and 6-minute walking test [6-MWT] were evaluated in both groups to assess the differences in lung function	6 months after surgery	Yes