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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03669328
Enrollment
200
Registered
2018-09-13
Start date
2016-06-01
Completion date
2018-06-30
Last updated
2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Cancer, Surgery

Keywords

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

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.

Interventions

Both groups received locoregional anesthesias

Sponsors

Institut Claudius Regaud
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of pain after surgery by Simple Verbal Evaluation1 day (the day of the surgery)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).

Secondary

MeasureTime frameDescription
Medical procedure characteristics1 day (the day of the surgery)The type of anesthesia performed, the surgical procedure as well as the analgesic strategy (ALR) and the antinausea strategy performed.
Evaluation of pain after surgery by Opioid requirements3 days (from surgery to 3 days after)Pain level in post-operative room measured and opioid requirement if important pain persists. The scale used is the visual analogue scale . If EVA\> 3 titration with morphine 1 mg per 1 mg is performed in the recovery room until an EVA \<3 is obtained. The dose of morphine in mg necessary to achieve this objective is collected.
Evaluation of home-based return capability by CHUNG score1 day (just after the surgery)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.Points are assigned to six variables : level of consciousness, physical activity, hemodynamic stability, oxygen saturation, pain, emetic symptoms. A score of 9 or 10 is needed to allow the patient to leave the hospital.
Incidence of postopérative nausea and vomiting after prevention strategy guided by Apfel score risk1 day before surgeryThe risk of postoperative nausea and vomiting (PONV) is evaluated by the Apfel score 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. The Apfel score includes four variables (Female sex, History of motion sickness or postoperative nausea and vomiting, Nonsmoker, Postoperative opioid treatment is planned) and assigns one point for each.
Evaluation of pain at home after surgery at rest by EVA during the first 3 days3 days (from surgery to 3 days after)Pain level (Analogic Visual Evaluation EVA) on the first 3 days after surgery, at rest. The EVA is a numeric scale of pain. The patient must estimate his pain level from 0 (no pain) to 10 (the most unsustainable pain ever experienced). The question asked by phone is between 0 no pain and 10 excruciating pain, where would you place your pain on this scale? This scale is validated by the entire scientific community as the most sensitive and above all the most reproducible and can be obtained by phone. an acceptable pain is \<3 therefore mild to moderate.
Evaluation of sleep quality3 days (from surgery to 3 days after)Sleep quality (wake up by pain or not during the night) during the 3 days after surgery. Patient is asked to answer yes or not to the question : Have you been awakened by pain during the night during first 3 days
Evaluation of pain at home after surgery at mobility by EVA during the first 3 days3 days (from surgery to 3 days after)Pain level (Analogic Visual Evaluation EVA) on the first 3 days after surgery at mobility. The EVA is a numeric scale of pain. The patient must estimate his pain level from 0 (no pain) to 10 (the most unsustainable pain ever experienced). The question asked by phone is between 0 no pain and 10 excruciating pain, where would you place your pain on this scale? This scale is validated by the entire scientific community as the most sensitive and above all the most reproducible and can be obtained by phone. an acceptable pain is \<3 therefore mild to moderate.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026