Perioperative Electroacupuncture on Postoperative Analgesia in Prostatectomy

Summary

The aim of the present study is the comparison of the efficacy of the perioperative application of a multimodal analgesia model to the patients, combing common used analgesics via intravenous (IV) route, such as tramadol and ketamine, with or without the Electroacupuncture (E/A) technique application and the frequency of side effects accession.

Conditions

• Pain, Postoperative

Interventions

DRUG

Tramadol

Tramadol 1.5mg/kg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of tramadol 0.15mg/kg/h started with continuous infusion in an adjustable flow disposable pump (paragon®)

DRUG

Ketamine

ketamine 10mg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of ketamine, in subanesthetic doses, 0,15mg/kg/h started with continuous infusion in an adjustable flow disposable pump (paragon®). Ketamine's dose was altered so as not to exceed the 300mg/24h.

DRUG

Tramadol

If NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients.The aim was that the Tramadol 24h dose would not exceed 600mg

DRUG

Morphine

If NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients and if the NRS scale was not decreased at least about 2 points after 30 minutes, morphine 2mg IV was then administered and it could be repeated

PROCEDURE

sedation

If the patient had sedation score \>2 then the analgesic infusion would be stopped, the patient would be assessed again in 1 hour and the infusion would start with the same or decreased flow.

PROCEDURE

rescue analgesia

Meanwhile - 45min,2h,6h,12h and 24h- if the patients had acute pain, the physician would call the anesthesiologist and a new assessment would take place with the relative interventions.

DRUG

Parecoxib

An hour before the end of the surgery all patients were administered with parecoxib 40mg (IV)

DRUG

paracetamol

30min before the end of the surgery paracetamol 20mg/kg (IV).

Sponsors & Collaborators

• Aristotle University Of Thessaloniki

  collaborator OTHER

• G.Gennimatas General Hospital

  lead OTHER

Principal Investigators

• VAGIA NTRITSOU · G.Gennimatas General Hospital

• DIMITRIOS VASILAKOS · Aristotle University Of Thessaloniki

• GEORGIOS DIMITRIADIS · G.Gennimatas General Hospital

• CHRISTOS KOSTOGLOU, MD · G.Gennimatas General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2011-09-30

Completion

2012-02-29

Countries

• Greece

Study Locations