Pain, Postoperative Clinical Trial
Official title:
Does the Preoperative Midazolam Dose Affect Postoperative Pain? - a Multicentric Randomized Controlled Trial in Ambulatory Surgery
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 ambulatory surgery.
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
clinical trial will be conducted in Portuguese ambulatory surgery units. A convenience sample
with consecutive design will include patients admitted for open inguinal hernia repair,
varicose vein stripping, knee arthroscopy or hallux valgus surgery under spinal anesthesia.
Patients will be randomized into 3 premedication groups, and this randomization will be
stratified for each centre and each type of surgery. Postoperative pain will be blindly
assessed by telephone interviews at 24h, 7 days, and 3 months.
The investigators will use multiple regression models to explore the interaction of midazolam
dose with preoperative anxiety, gender and chronic benzodiazepine use, as they hypothesize
there might be a differential effect of midazolam on postoperative pain amongst these
subgroups.
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