Pain, Postoperative
Conditions
Keywords
Midazolam, Inguinal hernia
Brief summary
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.
Detailed description
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.
Interventions
DRUGMidazolam injection
The dose of preoperative midazolam is the predictor variable and will be registered as a continuous variable in a single cohort.
Sponsors
Universidade do Porto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- adults proposed for open inguinal hernia repair in Portuguese ambulatory surgery units
Exclusion criteria
* psychiatric disorders * alcoholism * illiteracy or poor understanding of the Portuguese language * history of chronic pain under opioids * recurrent surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 24h after surgery | Pain numeric rating scale (NRS) 0-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 7 days after surgery | Pain NRS |
| Patient satisfaction | 7 days after surgery | NRS |
| Analgesic consumption | 24h after surgery | Total analgesic drugs taken in a time period |
| Adverse events | 7 days after surgery | Number of patients with adverse events like bleeding, nausea, uncontrolled pain |
| Global surgery recovery index | 3 months after surgery | Global surgery recovery index |
Countries
Portugal
Outcome results
None listed