Clinical trial NCT03669328: Evaluation of Pain and Postoperative Nausea Vomiting Incidence in Outpatient Surgery at IUCT-Oncopole Hospital
Official title: Evaluation of Pain and Postoperative Nausea Vomiting Incidence in Outpatient Surgery at IUCT-Oncopole Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Cancer
Surgery
Keywords: Surgery
cancer
anesthesia
pain
outcome patient
Postoperative Nausea and Vomiting
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Detailed description: During the anesthesia consultation, the risk of postoperative nausea and vomiting (PONV) is evaluated by the Apfel score (Apfel CC, Anesthesiology 1999) and a preventive strategy correlated to this score is then determined. An order including anti-emetics and analgesics is given to the patient for the return home after the outpatient surgery.

On the day of the outpatient surgery, patients receive in the operating room the prevention of PONV according to their level of risk (according to the recommendations of the Société Française d'Anesthésie et de Réanimation - SFAR 2008 and Guidelines 2014) and analgesics including a level II and NSAIDs (in the absence of contraindication).

All patients underwent general anaesthesia with sufentanil and propofol. Mechanical ventilation was performed with laryngeal mask. A echoguided regional anesthesia was performed by injection of 20 ml of ropivacaine 3.75 mg/ml above and under the serratus muscle as described by Blanco and al (ref 3)" In the postoperative recovery room, PONV is treated if necessary by an anti-emetic class different from those used in the block. In postoperative pain with EVA\> 3, morphine titration is performed as recommended.

Patients are then monitored in an outpatient surgery unit until they have a home-based return capability assessed by the CHUNG score, including the level of pain (moderate and well relieved), the absence of persistent nausea, and the ability to ambulation.

All outpatient surgery patients are called the day after their return home to ensure the absence of complications according to the regulatory procedure related to outpatient anesthesia.

As part of this evaluation, information on the level of pain at rest and mobility, as well as the frequency of PONV are also recorded and this follow-up is repeated in D2 and D3 after the intervention.

This information is then correlated with the type of anesthesia performed, the surgical procedure as well as the analgesic strategy (ALR) and the antinausea strategy performed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Evaluation of pain after surgery by Simple Verbal Evaluation
timeFrame: 1 day (the day of the surgery)
Secondary outcomes:
measure: Incidence of postopérative nausea and vomiting after prevention strategy guided by Apfel score risk
timeFrame: 1 day before surgery
measure: Medical procedure characteristics
timeFrame: 1 day (the day of the surgery)
measure: Evaluation of pain after surgery by Opioid requirements
timeFrame: 3 days (from surgery to 3 days after)
measure: Evaluation of home-based return capability by CHUNG score
timeFrame: 1 day (just after the surgery)
measure: Evaluation of pain at home after surgery at mobility by EVA during the first 3 days
timeFrame: 3 days (from surgery to 3 days after)
measure: Evaluation of pain at home after surgery at rest by EVA during the first 3 days
timeFrame: 3 days (from surgery to 3 days after)
measure: Evaluation of sleep quality
timeFrame: 3 days (from surgery to 3 days after)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius Regaud
state: Occitanie
Study officials:
affiliation: Institut Claudius Regaud
name: Amel Daboussi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.