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Completed

NCT Number: NCT03499730

Does Midazolam Affect Postoperative Pain?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar Baixo Vouga, EPE, Aveiro, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midazolam injection

Drug

The dose of preoperative midazolam is the predictor variable and will be registered as a continuous variable in a single cohort.

Primary outcomes

  1. Postoperative pain

    Time frame: 24h after surgery

    Pain numeric rating scale (NRS) 0-10

Secondary outcomes

  1. Postoperative pain

    Time frame: 7 days after surgery

    Pain NRS

  2. Postoperative pain

    Time frame: 3 months after surgery

    Pain NRS

  3. Patient satisfaction

    Time frame: 7 days after surgery

    NRS

  4. Patient satisfaction

    Time frame: 3 months after surgery

    NRS

  5. Analgesic consumption

    Time frame: 24h after surgery

    Total analgesic drugs taken in a time period

  6. Analgesic consumption

    Time frame: 7 days after surgery

    Total analgesic drugs taken in a time period

  7. Adverse events

    Time frame: 7 days after surgery

    Number of patients with adverse events like bleeding, nausea, uncontrolled pain

  8. Global surgery recovery index

    Time frame: 3 months after surgery

    Global surgery recovery index

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

Does Preoperative Midazolam Dose Affect Postoperative Pain? - a Multicentric Observational Study in Open Inguinal Hernia Repair

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 17, 2018
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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