NCT02630849

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

December 7, 2015

Last Update Submit

December 14, 2015

Conditions

Chronic Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Mid term Brief Pain Inventory Scale Variation

    1 month after surgery

  • Pulmonary functional tests

    6 months after surgery

Study Arms (2)

IMF group

EXPERIMENTAL

intercostal muscle flap and pericostal no-compression suture of the intercostal space

Procedure: intercostal muscle flap and pericostal no-compression suture

IINB group

ACTIVE COMPARATOR

Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block

Procedure: Standard suture technique of the intercostal space

Interventions

intercostal muscle flap and pericostal no-compression suturePROCEDURE

intercostal muscle flap and pericostal no-compression suture of the intercostal space

IMF group
Standard suture technique of the intercostal spacePROCEDURE

Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block

IINB group

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1016/0304-3959(95)00156-5.

    PMID: 8826494BACKGROUND

  • 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.

    PMID: 18498792BACKGROUND

  • 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. doi: 10.1016/j.ejcts.2006.01.002. Epub 2006 Feb 14.

    PMID: 16481188BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Erino A. Rendina, Professor

    University of Roma La Sapienza

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 15, 2015

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 15, 2015

Record last verified: 2015-12