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Does the Preoperative Midazolam Dose Affect Postoperative Pain?

NCT03534895 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2018-05-23

No results posted yet for this study

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 ambulatory surgery.

The investigators hypothesize that patients being administered higher midazolam doses will refer more pain.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Midazolam Injectable Solution

intravenous

OTHER

Normal saline

intravenous

PROCEDURE

Spinal anesthesia

8mg of heavy bupivacaine 0.5% injected in the subarachnoid space, during lateral decubitus

PROCEDURE

Surgery

Open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery

DRUG

Postoperative analgesia

IV acetaminophen 1g + IV ketorolac 30mg

DRUG

Rescue analgesia

Tramadol 2mg/Kg IV in 100mL of normal saline, if pain NRS\>3.

DRUG

Wound infiltration

Wound infiltration with 10mL of ropivacaine 0.75%, in open inguinal hernia repair

DRUG

Analgesia at home

Oral acetaminophen 1g 6/6h + ibuprofen 400mg 8/8h (+ rescue analgesia with tramadol 50mg 6/6h)

Sponsors & Collaborators

  • Centro Hospitalar de Entre o Douro e Vouga

    collaborator OTHER

  • Centro Hospitalar de Vila Nova de Gaia/Espinho

    collaborator OTHER

  • Universidade do Porto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2020-05-31
Completion
2020-08-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534895 on ClinicalTrials.gov