Trial | NCT03534895  Report issue

Title

Does the Preoperative Midazolam Dose Affect Postoperative Pain?
Does the Preoperative Midazolam Dose Affect Postoperative Pain? - a Multicentric Randomized Controlled Trial in Ambulatory Surgery

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    168
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 Started
May 31
2019
Anticipated
Primary Completion
May 31
2020
Anticipated
Study Completion
Aug 31
2020
Anticipated
Last Update
May 23
2018

Drug Midazolam Injectable Solution

intravenous

  • Other names: Dormicum

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 [acetaminophen (tylenol), ketorolac (acuvail)]

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 [acetaminophen (tylenol), tramadol (Ultram), ibuprofen (motrin)]

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

PC1 Placebo Comparator

5mL normal saline intravenous, single-administration, as pre-medication

PC2 Experimental

midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication

PC3 Experimental

midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication

Criteria 

Inclusion Criteria:

adult patients submitted to open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery in Portuguese ambulatory surgery units

Exclusion Criteria:

psychiatric disorders
alcoholism
illiteracy or poor understanding of Portuguese language
history of chronic pain under opioids
recurrent surgery
contraindication for midazolam or deep sedation
contraindication for spinal anesthesia
No Results Posted