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

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ClinicalTrials.gov Identifier: NCT03669328
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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.


Condition or disease Intervention/treatment
Anesthesia Cancer Surgery Procedure: locoregional anesthesia

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: Evaluation of Pain and Postoperative Nausea Vomiting Incidence in Outpatient Surgery at IUCT-Oncopole Hospital
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
patients of 2016, June with locoregional anesthesia
Procedure: locoregional anesthesia
Both groups received locoregional anesthesias

Group 2
patients of 2018, June with locoregional anesthesia
Procedure: locoregional anesthesia
Both groups received locoregional anesthesias




Primary Outcome Measures :
  1. Evaluation of pain after surgery by Simple Verbal Evaluation [ Time Frame: 1 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 Outcome Measures :
  1. Incidence of postopérative nausea and vomiting after prevention strategy guided by Apfel score risk [ Time Frame: 1 day before surgery ]
    The 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.

  2. Medical procedure characteristics [ Time Frame: 1 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.

  3. Evaluation of pain after surgery by Opioid requirements [ Time Frame: 3 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.

  4. Evaluation of home-based return capability by CHUNG score [ Time Frame: 1 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.

  5. Evaluation of pain at home after surgery at mobility by EVA during the first 3 days [ Time Frame: 3 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.


  6. Evaluation of pain at home after surgery at rest by EVA during the first 3 days [ Time Frame: 3 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.


  7. Evaluation of sleep quality [ Time Frame: 3 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669328


Locations
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France
Institut Claudius Regaud
Toulouse, Occitanie, France, 31100
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
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Principal Investigator: Amel Daboussi, PhD Institut Claudius Regaud
Additional Information:

Publications of Results:
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03669328    
Other Study ID Numbers: 16HLGENF01
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Surgery
cancer
anesthesia
pain
outcome patient
Postoperative Nausea and Vomiting
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs