Perioperative Electroacupuncture on Postoperative Analgesia in Prostatectomy

NCT01526525 | Completed Phase 4

• 1 other identifier: 6151/ 22-7-2009
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tramadol; ketamine; parecoxib; paracetamol; numerical rating scale (NRS); McGill (SF-MPQ); electronic pressure algometer; Spielberger State Trait Anxiety Inventory STAI Y-6 item

Outcome Measures

Primary Outcomes (5)

• PAIN SCALES

  Numerical Rating Scale (NRS) 0-10,from 0=no pain to 10=worst pain imaginable. Present Pain Intensity (PPI) 0-5,from 0= no pain to 5= excruciating. McGill pain scale (SF-MPQ) 0-3,from 0=no pain to 3=severe pain

  45min, 2h, 6h, 12h and 24h following the surgery

• PATIENTS PAIN THRESHOLD WITH ELECTRONIC PRESSURE ALGOMETER

  The electronic pressure algometer device was applied 2cm bilateral the middle of the midline extraperitoneal lower abdominal incision and were recorded the pain threshold. It converted in Kg

  45min, 2h, 6h, 12h and 24h following the surgery

• NUMBER OF PARTICIPANTS WITH ADVERSE EVENTS

  Nausea:yes/no vomiting:yes/no pruritus:yes/no bowel movement:yes/no Sedation scale 0-3, from 0= awake or sleepy that answers to the questions to 3=asleep who doesn't awake not even with a prod

  45min, 2h, 6h, 12h and 24h following the surgery

• PATIENTS RESCUE ANALGESIA

  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. The aim was that the Tramadol 24h dose would not exceed 600mg. So with rescue analgesia, tramadol or morphine in mg, we count the total amount of opioids administered

  45min, 2h, 6h,12h and 24h following the surgery

• CORTIZOL

  Cortizol levels: ug/dl

  : 1st at 8am at the day of the surgery (Cort1), 2nd 45min after the end of the surgery (Cort2) and 3rd at 8am the first postoperative day (Cort3)

Secondary Outcomes (3)

• PATIENTS WELLBEING,

  Preoperatively and 24h following the surgery

• SATISFACTION

  24h following the surgery

• SLEEP DISORDERS

  24h following the surgery

Study Arms (2)

TK

PLACEBO COMPARATOR

In TK group when the closure of the abdominal walls started, a certified acupuncturist expert put needles, Ener-Qi 0.26Χ25mms, in LI4 point in both hands, the needles were not inserted in the skin but they were put atop the skin and were secured by adhesive tape. For 30min in the E/A stimulator ITO ES-160 the indicator light was on but no electrical current was applied. Thereafter the E/A device deactivated and after the awakening of the patients, it was connected in ST36 and LI4 points for 30min with the same technique. The electrodes were connected to each other in every point, as the right with the left point of LI4 and the right with the left point of ST36. The patients were told that they may or may not feel electrical current because of its very high frequency.

Drug: Tramadol; Drug: Ketamine; Drug: Morphine; Procedure: sedation; Procedure: rescue analgesia; Drug: Parecoxib; Drug: paracetamol

TKE

ACTIVE COMPARATOR

In TKE group when the closure of the abdominal walls started, a certified acupuncturist expert put needles, Ener-Qi 0.26Χ25mms, in LI4 point at 2cm depth in both hands and E/A was applied for 30min with the E/A stimulator ITO ES-160 in constant pulse program with 300μs duration and 100Hz frequency. After the needles were connected to the E/A stimulator, they were secured by adhesive tape. The response which certified the right needle placement was the adjacent muscular twitch. Thereafter the E/A device was deactivated and after the awakening of the patients, E/A was administered in ST36 and LI4 points for 30min with 4Hz frequency. The electrodes were connected to each other in every point, as the right with the left point of LI4 and the right with the left point of ST36.

Drug: Tramadol; Drug: Ketamine; Drug: Morphine; Procedure: sedation; Procedure: rescue analgesia; Drug: Parecoxib; Drug: paracetamol

Interventions

Tramadol DRUG

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®)

TK; TKE

Ketamine DRUG

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.

TK; TKE

Morphine DRUG

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

TK; TKE

sedation PROCEDURE

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.

TK; TKE

rescue analgesia PROCEDURE

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.

TK; TKE

Parecoxib DRUG

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

TK; TKE

paracetamol DRUG

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

TK; TKE

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patient is over 18 years old, especially 50-75 years old
• Patient scheduled for a non-emergency operation
• Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

You may not qualify if:

• Patient receiving monoamine oxidase inhibitors and selective serotonin reuptake inhibitors
• Patient with significant cardiovascular, pulmonary, renal or hepatic disease
• Patient with epilepsy non controlled with treatment or history of seizures
• Patient with morbid obesity (BMI\>35)
• Patient with history of chronic opioid exposure
• Patient with history of chronic pain
• Patient with history of postoperative nausea and vomiting
• Patient with cognitive dysfunction
• Patient with history of previous usage of the acupuncture technique
• Patient Greek speaking
• Patient is participating in another clinical trial which may affect this study's outcomes
• Patient with metastatic cancer

Sponsors & Collaborators

• G.Gennimatas General Hospital: lead
• Aristotle University Of Thessaloniki: collaborator

Study Sites (1)

G.Gennimatas GENERAL HOSPITAL OF THESSALONIKI

Thessaloniki, 54635, Greece

Location

Related Publications (1)

• Ntritsou V, Mavrommatis C, Kostoglou C, Dimitriadis G, Tziris N, Zagka P, Vasilakos D. Effect of perioperative electroacupuncture as an adjunctive therapy on postoperative analgesia with tramadol and ketamine in prostatectomy: a randomised sham-controlled single-blind trial. Acupunct Med. 2014 Jun;32(3):215-22. doi: 10.1136/acupmed-2013-010498. Epub 2014 Jan 30.

  PMID: 24480836 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol; Ketamine; Morphine; parecoxib; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• VAGIA NTRITSOU

  G.Gennimatas General Hospital

  PRINCIPAL INVESTIGATOR

• DIMITRIOS VASILAKOS

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

• GEORGIOS DIMITRIADIS

  G.Gennimatas General Hospital

  STUDY DIRECTOR

• CHRISTOS KOSTOGLOU, MD

  G.Gennimatas General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ANESTHESIOLOGIST

Study Record Dates

• First Submitted: January 28, 2012
• First Posted: February 6, 2012
• Study Start: July 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 21, 2014

Record last verified: 2014-02

Locations

GR (1)