The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients

Summary

Patients with a daily use of opioids may develop higher postoperative pain levels, often need high doses of morphine and therefore their pain may be difficult to treat. A low dose of an old anesthetic drug, ketamine, administered during surgery can possibly reduce pain and morphine consumption in these patients. Our purpose is to investigate the effect of low dose ketamine on morphine consumption and pain after spine surgery in patients with a daily use of opioids. Our hypothesis is that low dose ketamine can reduce morphine consumption, pain and side-effects after spine surgery.

Conditions

• Postoperative Pain
• Chronic Pain
• Analgesics

Interventions

DRUG

(S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml

Ketamine (25 mg/ml) bolus 0.5 mg/kg administered immediately after induction of anesthesia, followed by infusion ketamine 0,25 mg/kg/hour that is terminated when the last suture to the skin has been performed.

DRUG

Isotonic sodium chloride 0.9 percent

Isotonic sodium chloride 0.9 percent 0.02 ml/kg administered immediately after induction of anesthesia, followed by infusion isotonic sodium chloride 0.01 ml/kg/hour that is terminated when the last suture to the skin has been performed.

DRUG

Paracetamol 1 g

Paracetamol 1 g orally 1 hour preoperatively and every 6 hours after extubation time during the first 24 hours.

DRUG

Morphine Sulphate 1 mg/ml

Morphine Sulphate 1 mg/ml administered as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 5 minutes) 0-24 hours postoperatively

DRUG

Morphine Sulphate 1 mg/ml

Morphine Sulphate 1 mg/ml, bolus 2.5 mg administered by the PACU nurse on request of the patient for the first hour postoperatively.

DRUG

Ondansetron 2 mg/ml

Ondansetron 2 mg/ml 4 mg iv in case of moderate to severe nausea, supplemented by Ondansetron 1 mg iv if needed

DRUG

Usual daily opioids

The patients usual daily opioid consumption are administered during the study period

DRUG

Morphine Sulphate 1 mg/ml

Morphine Sulphate 1 mg/ml, bolus 0.4 mg/kg administered 45 minutes before expected awakening.

DRUG

Sufentanil 5 microgram/ml

Sufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening.

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Rikke V Nielsen, MD · Glostrup University Hospital, Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2015-10-31

Completion

2016-11-01

Countries

• Denmark

Study Locations