Evaluation of Pain and Postoperative Nausea Vomiting Incidence in Outpatient Surgery at IUCT-Oncopole Hospital

NCT03669328 | Completed

• 1 other identifier: 16HLGENF01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The effectiveness of the analgesic and anti-nausea prevention techniques of the investigators justifies being evaluated regularly in order to adapt the management strategy to the specificities of each surgical act. A first evaluation took place in June 2016 and allowed to identify a category of patients (partial breast surgery with or without axillary gesture) not benefiting from an ideal algological management because justifying in 30% of the cases of a level 3 analgesic remedy in the postoperative recovery room. This use of morphine results in a significant incidence of postoperative nausea and prolonged recovery time before return home harmful to the patient. With their experience in locoregional anesthesia technique in complete breast surgery (total mastectomy) and aware of the effectiveness of this type of anesthesia on the management of immediate and chronic pain, the investigators have extended their indications of ALR to partial breast surgery in ambulatory.

Conditions

Anesthesia; Cancer; Surgery

Keywords

Surgery; cancer; anesthesia; pain; outcome patient; Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Evaluation of pain after surgery by Simple Verbal Evaluation

  Pain level in post-operative room measured by Simple Verbal Evaluation. The simple verbal scale or Keele scale has 5 qualifiers to describe the intensity of the pain, each descriptor is associated with a numerical value. 0 = no pain, 1 = poor, 2 = moderate, 3 = intense, 4 = atrocious. The goal of management is to achieve pain values below 3 (low to moderate).

  1 day (the day of the surgery)

Secondary Outcomes (7)

• Incidence of postopérative nausea and vomiting after prevention strategy guided by Apfel score risk

  1 day before surgery

• Medical procedure characteristics

  1 day (the day of the surgery)

• Evaluation of pain after surgery by Opioid requirements

  3 days (from surgery to 3 days after)

• Evaluation of home-based return capability by CHUNG score

  1 day (just after the surgery)

• Evaluation of pain at home after surgery at mobility by EVA during the first 3 days

  3 days (from surgery to 3 days after)

Study Arms (2)

Group 1

patients of 2016, June with locoregional anesthesia

Procedure: locoregional anesthesia

Group 2

patients of 2018, June with locoregional anesthesia

Procedure: locoregional anesthesia

Interventions

locoregional anesthesia PROCEDURE

Both groups received locoregional anesthesias

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

During the period from 01 to 30 June 2016, all patients admitted for ambulatory surgery under general anesthesia were included in this prospective "before-after" study. To have two perfectly comparable populations, we chose to reassess all patients in outpatient surgery combined, on the second period (18 to 5 July 2018), even if our changes of care only concerns breast.

You may qualify if:

• patients admitted for ambulatory surgery under general anesthesia
• patients admitted during the period from 01 to 30 June 2016 or during the period from 18 to 5 July 2018

You may not qualify if:

• Patient neither French nor English,
• Patient refusing to participate in this study
• Minor patients were excluded to ensure the homogeneity of the surveyed population (satisfaction of minors not meeting the same characteristics as that of adults)

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Claudius Regaud

Toulouse, Occitanie, 31100, France

Location

Related Publications (5)

• Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

  PMID: 19903919 RESULT

• Fuzier R, Puel F, Izard P, Sommet A, Pierre S. Prospective cohort study assessing chronic pain in patients following minor surgery for breast cancer. J Anesth. 2017 Apr;31(2):246-254. doi: 10.1007/s00540-016-2288-9. Epub 2016 Nov 24.

  PMID: 27885426 RESULT

• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

  PMID: 22939099 RESULT

• Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.

  PMID: 15733628 RESULT

• Kumar SP. Utilization of brief pain inventory as an assessment tool for pain in patients with cancer: a focused review. Indian J Palliat Care. 2011 May;17(2):108-15. doi: 10.4103/0973-1075.84531.

  PMID: 21976850 RESULT

MeSH Terms

Conditions

Neoplasms; Pain; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Amel Daboussi, PhD

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 13, 2018
• Study Start: June 1, 2016
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)