Does Midazolam Affect Postoperative Pain?

Overview

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.

Full Title of Study: “Does Preoperative Midazolam Dose Affect Postoperative Pain? – a Multicentric Observational Study in Open Inguinal Hernia Repair”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 5, 2020

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative pain
    • Time Frame: 24h after surgery
    • Pain numeric rating scale (NRS) 0-10

Secondary Measures

  • Postoperative pain
    • Time Frame: 7 days after surgery
    • Pain NRS
  • Postoperative pain
    • Time Frame: 3 months after surgery
    • Pain NRS
  • Patient satisfaction
    • Time Frame: 7 days after surgery
    • NRS
  • Patient satisfaction
    • Time Frame: 3 months after surgery
    • NRS
  • Analgesic consumption
    • Time Frame: 24h after surgery
    • Total analgesic drugs taken in a time period
  • Analgesic consumption
    • Time Frame: 7 days after surgery
    • Total analgesic drugs taken in a time period
  • Adverse events
    • Time Frame: 7 days after surgery
    • Number of patients with adverse events like bleeding, nausea, uncontrolled pain
  • Global surgery recovery index
    • Time Frame: 3 months after surgery
    • Global surgery recovery index

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidade do Porto
  • Provider of Information About this Clinical Study
    • Principal Investigator: Caroline Dahlem, Principal Investigator – Universidade do Porto
  • Overall Official(s)
    • Caroline Dahlem, MD, Principal Investigator, UPorto /CINTESIS

References

Mantegazza P, Parenti M, Tammiso R, Vita P, Zambotti F, Zonta N. Modification of the antinociceptive effect of morphine by centrally administered diazepam and midazolam. Br J Pharmacol. 1982 Apr;75(4):569-72. doi: 10.1111/j.1476-5381.1982.tb09175.x.

Okulicz-Kozaryn I, Kaminska E, Luczak J, Szczawinska K, Kotlinska-Lemieszek A, Baczyk E, Mikolajczak P. The effects of midazolam and morphine on analgesic and sedative activity of ketamine in rats. J Basic Clin Physiol Pharmacol. 2000;11(2):109-25. doi: 10.1515/jbcpp.2000.11.2.109.

Tatsuo MA, Salgado JV, Yokoro CM, Duarte ID, Francischi JN. Midazolam-induced hyperalgesia in rats: modulation via GABA(A) receptors at supraspinal level. Eur J Pharmacol. 1999 Apr 1;370(1):9-15. doi: 10.1016/s0014-2999(99)00096-5.

Frolich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d.

Kain ZN, Sevarino F, Pincus S, Alexander GM, Wang SM, Ayoub C, Kosarussavadi B. Attenuation of the preoperative stress response with midazolam: effects on postoperative outcomes. Anesthesiology. 2000 Jul;93(1):141-7. doi: 10.1097/00000542-200007000-00024.

Coulthard P, Rood JP. An investigation of the effect of midazolam on the pain experience. Br J Oral Maxillofac Surg. 1992 Aug;30(4):248-51. doi: 10.1016/0266-4356(92)90268-n.

Day MA, Rich MA, Thorn BE, Berbaum ML, Mangieri EA. A placebo-controlled trial of midazolam as an adjunct to morphine patient-controlled analgesia after spinal surgery. J Clin Anesth. 2014 Jun;26(4):300-8. doi: 10.1016/j.jclinane.2013.12.011. Epub 2014 Jun 2.

Hasani A, Maloku H, Sallahu F, Gashi V, Ozgen SU. Preemptive analgesia with midazolam and diclofenac for hernia repair pain. Hernia. 2011 Jun;15(3):267-72. doi: 10.1007/s10029-010-0772-y. Epub 2010 Dec 28.

Ong CK, Seymour RA, Tan JM. Sedation with midazolam leads to reduced pain after dental surgery. Anesth Analg. 2004 May;98(5):1289-93, table of contents. doi: 10.1213/01.ane.0000111107.18755.cc.

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