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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
intravenous
intravenous
8mg of heavy bupivacaine 0.5% injected in the subarachnoid space, during lateral decubitus
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
Assessed by the Brief Pain Inventory severity score (24h recall time): mean of 4 items assessing pain at the moment of the interview, on average, at its least and at its worst during the last 24h
Time frame: Day 1 after surgery
Postoperative pain
Assessed by the Brief Pain Inventory severity score (24h recall time): mean of 4 items assessing pain at the moment of the interview, on average, at its least and at its worst during the last 24h. Features of neuropathic pain as assessed by DN4 patient-reported symptoms
Time frame: Day 7 after surgery
Postoperative pain
Assessed by the Brief Pain Inventory severity score (24h recall time): mean of 4 items assessing pain at the moment of the interview, on average, at its least and at its worst during the last 24h. Features of neuropathic pain as assessed by DN4 patient-reported symptoms
Time frame: Month 3 after surgery
Pain interference in daily life
Assessed by the Brief Pain Inventory interference score (24h recall time): interference of pain in general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.
Time frame: Day 1 after surgery
Pain interference in daily life
Assessed by the Brief Pain Inventory interference score (24h recall time): interference of pain in general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.
Time frame: Day 7 after surgery
Pain interference in daily life
Assessed by the Brief Pain Inventory interference score (24h recall time): interference of pain in general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.
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Open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery
IV acetaminophen 1g + IV ketorolac 30mg
Tramadol 2mg/Kg IV in 100mL of normal saline, if pain NRS\>3.
Wound infiltration with 10mL of ropivacaine 0.75%, in open inguinal hernia repair
Oral acetaminophen 1g 6/6h + ibuprofen 400mg 8/8h (+ rescue analgesia with tramadol 50mg 6/6h)
Time frame: Month 3 after surgery
Analgesic consumption
Total analgesic drugs taken in a time period (first day after surgery)
Time frame: Day 1 after surgery
Analgesic consumption
Total analgesic drugs taken in a time period (first week after surgery)
Time frame: Day 7 after surgery
Patient satisfaction
NRS 0-10
Time frame: Day 7 after surgery
Patient satisfaction
NRS 0-10
Time frame: Month 3 after surgery
Adverse events
Number of patients with adverse events like bleeding, nausea, uncontrolled pain
Time frame: Day 7 after surgery
Global surgery recovery index
Global surgery recovery index (0-100%)
Time frame: Month 3 after surgery