Dexmedetomidine is a drug that is used mainly for sedation in the intensive care unit. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. DEXPAIN-study has been approved by Kuopio university hospitals ethics committee.

Dexmedetomidine infusion in pain management during low back surgery Dexmedetomidine is an alpha-2-adrenergic agonist that is used mainly for sedation in the intensive care unit. Alpha-2-adrenoceptors agonists have several beneficial actions in a surgical patient. They decrease symphatetic tone, reduce anesthetic and opioid requirements and cause sedation and analgesia. Pain after low back surgery is intense and can become chronic. We need a new drug to manage pain during postoperative period and to prevent chronic pain. DEXPAIN-study has been approved by Kuopio university hospitals ethics committee. Study is single centered, randomized and placebo-controlled study. A total of 60 patients scheduled for low back surgery will be enrolled in this study. Patients eligibility will be assessed by pre-determined inclusion-exclusion-criteria. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. Patients in the dexmedetomidine group receive dexmedetomidine loading dose 1ug/kg for 10 minutes and continuous infusion 1.4 ug/kg/h during surgery and post-anesthesia care unit. Total infusion time will be four hours. Anesthesia is standardized and post-operative pain is treated with patient controlled analgesia made of oxycodone. Questionnaires will be used to assess pain control. Study is scheduled to start as soon as we obtain permission from Finnish Medicines Agency and receive sufficient funding.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002694-37-FI

Enrollment

Registered

2016-01-04

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low back pain, Discus prolapse, Spinal stenosis

Interventions

Trade Name: Dexmedetomidine Product Name: Dexdor Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775-47-6 Pharmaceutical form

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients age 18 - 35 kg/m2, Patient scheduled for lumbar disc surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age 70 years, BMI 35 kg/m2, Allergic to dexmedetomidine, Renal- or liver impairment, Sleep apnea syndrome, chronic pain

Design outcomes

Primary

Measure	Time frame
Main Objective: Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. ;Secondary Objective: Not applicable;Primary end point(s): Post-operative oxycodone consumption;Timepoint(s) of evaluation of this end point: First and Second postoperative day	—

Secondary

Measure	Time frame
Secondary end point(s): Pain one month after surgery;Timepoint(s) of evaluation of this end point: one month after surgery	—

Countries

Finland

Contacts

Public ContactClinic of anesthesiology

Kuopio university hospital

antti.mykkanen@kuh.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026