Does Midazolam Affect Postoperative Pain?

Completed

• Conditions: Pain, Postoperative

• Registration Number: NCT03499730
• Lead Sponsor: Universidade do Porto

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.

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-15
• Study First Posted: 2018-04-17
• Study Start: 2018-09-12
• Primary Completion: 2020-06-05
• Study Completion: 2021-03-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-15
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain	24h after surgery	Pain numeric rating scale (NRS) 0-10

Secondary Outcome Measures

Name	Time	Method
Global surgery recovery index	3 months after surgery	Global surgery recovery index
Patient satisfaction	3 months after surgery	NRS
Postoperative pain	3 months after surgery	Pain NRS
Analgesic consumption	7 days 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

Trial Locations

Locations (4)

Centro Hospitalar Baixo Vouga, EPE; 🇵🇹 Aveiro, Portugal

Centro Hospitalar Vila Nova de Gaia / Espinho, EPE; 🇵🇹 Vila Nova De Gaia, Portugal

Centro Hospitalar Universitário do Algarve; 🇵🇹 Faro, Portugal

Centro Hospitalar Entre Douro e Vouga, EPE; 🇵🇹 Santa Maria Da Feira, Portugal