NCT03534895

Does the Preoperative Midazolam Dose Affect Postoperative Pain?

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-05-01
• Completion: 2020-08-01
• First posted: 2018-05-23
• Last updated: 2018-05-23

Locations

2 sites across 1 country: Portugal