To investigate whether midazolam has any effect on postoperative pain in outpatient surgery, the investigators will assess the impact of different midazolam doses on pain scores 24h, 7 days and 3 months after open inguinal hernia repair. The investigators hypothesize that patients being administered higher midazolam doses will refer more pain.
Systemic midazolam prescribed perioperatively might have impact on pain, with studies suggesting antinociceptive and hyperalgesic effects. Anxiety might be a confounder in this association. In order to investigate the effect of midazolam on postoperative pain, a prospective cohort study will be conducted in four Portuguese ambulatory surgery units. A convenience sample with consecutive design will include patients admitted for open inguinal hernia repair. After anxiety and pain evaluation, a tailored dose of midazolam will be administered as premedication according to the anesthetist's best judgement within each unit's protocol (routine care; this dose may be null). Subsequent anesthesia and analgesia will be standardized. Postoperative pain will be blindly assessed by telephone interviews at 24h, 7 days, and 3 months. Statistical analysis will be performed separately for each gender, centre and type of anesthesia, adjusting for preoperative anxiety and other confounding variables with multivariate analysis. The investigators intend to clarify the relation between anxiety, preoperative midazolam and postoperative pain.
Study Type
OBSERVATIONAL
Enrollment
300
The dose of preoperative midazolam is the predictor variable and will be registered as a continuous variable in a single cohort.
Centro Hospitalar Baixo Vouga, EPE
Aveiro, Portugal
Centro Hospitalar Universitário do Algarve
Faro, Portugal
Centro Hospitalar Entre Douro e Vouga, EPE
Santa Maria da Feira, Portugal
Centro Hospitalar Vila Nova de Gaia / Espinho, EPE
Vila Nova de Gaia, Portugal
Postoperative pain
Pain numeric rating scale (NRS) 0-10
Time frame: 24h after surgery
Postoperative pain
Pain NRS
Time frame: 7 days after surgery
Postoperative pain
Pain NRS
Time frame: 3 months after surgery
Patient satisfaction
NRS
Time frame: 7 days after surgery
Patient satisfaction
NRS
Time frame: 3 months after surgery
Analgesic consumption
Total analgesic drugs taken in a time period
Time frame: 24h after surgery
Analgesic consumption
Total analgesic drugs taken in a time period
Time frame: 7 days after surgery
Adverse events
Number of patients with adverse events like bleeding, nausea, uncontrolled pain
Time frame: 7 days after surgery
Global surgery recovery index
Global surgery recovery index
Time frame: 3 months after surgery
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