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Perioperative Electroacupuncture on Postoperative Analgesia in Prostatectomy

This study has been completed.
Sponsor:
Collaborator:
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
NTRITSOU VAGIA, MD, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier:
NCT01526525
First received: January 28, 2012
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Drug: Tramadol
Drug: Ketamine
Drug: Morphine
Procedure: sedation
Procedure: rescue analgesia
Drug: Parecoxib
Drug: paracetamol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Perioperative Electroacupuncture With Tramadol and Ketamine on Postoperative Analgesia in Prostatectomy: a Randomized Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by G.Gennimatas General Hospital:

Primary Outcome Measures:
  • PAIN SCALES [ Time Frame: 45min, 2h, 6h, 12h and 24h following the surgery ] [ Designated as safety issue: Yes ]
    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

  • PATIENTS PAIN THRESHOLD WITH ELECTRONIC PRESSURE ALGOMETER [ Time Frame: 45min, 2h, 6h, 12h and 24h following the surgery ] [ Designated as safety issue: Yes ]
    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

  • NUMBER OF PARTICIPANTS WITH ADVERSE EVENTS [ Time Frame: 45min, 2h, 6h, 12h and 24h following the surgery ] [ Designated as safety issue: Yes ]
    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

  • PATIENTS RESCUE ANALGESIA [ Time Frame: 45min, 2h, 6h,12h and 24h following the surgery ] [ Designated as safety issue: Yes ]
    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

  • CORTIZOL [ Time Frame: : 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) ] [ Designated as safety issue: Yes ]
    Cortizol levels: ug/dl


Secondary Outcome Measures:
  • PATIENTS WELLBEING, [ Time Frame: Preoperatively and 24h following the surgery ] [ Designated as safety issue: Yes ]
    Spielberger State Trait Anxiety Inventory (STAI Y-6 item) 1-4, where 1=not at all and 4 =very much so.

  • SATISFACTION [ Time Frame: 24h following the surgery ] [ Designated as safety issue: Yes ]
    Verbal Rating Scale (VRS) with 6 levels of satisfaction 1-6,from 1=very dissatisfied to 6= very satisfied

  • SLEEP DISORDERS [ Time Frame: 24h following the surgery ] [ Designated as safety issue: Yes ]
    Answer to questions such as "if they slept well?" yes/no "they had nightmares or bad dreams?" yes/no


Enrollment: 70
Study Start Date: July 2009
Study Completion Date: February 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: TK
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
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).
Active Comparator: TKE
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
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).

Detailed Description:

Seventy patients were scheduled for radical prostatectomy, were recruited to this prospective single-blind, were randomized and placebo-controlled by trial. They were randomly divided into two groups of 35 patients each by a computer-generated randomization sequence, the TKE (Tramadol + Ketamine + Electroacupuncture), and TK (Tramadol + Ketamine + placebo Electroacupuncture.The randomization performed by the certified acupuncturist.

Patients were anesthetized with the same protocol by five anesthesiologists, who were not involved in the postoperative assessment of the patients, but were aware in which group acupuncture was used and in which not. Both groups, TKE and TK, were administered tramadol 1.5mg/kg and ketamine 10mg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of tramadol 0.15mg/kg/h and 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. An hour before the end of the surgery all patients were administered with parecoxib 40mg (IV) and 30min before paracetamol 20mg/kg (IV).

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 electroacupuncture machine 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. In the TK group the needles were not inserted in the skin but they were put atop the skin and were secured by adhesive tape, the indicator light was on but no electrical current was applied. The patients were told that they may or may not feel electrical current because of its very high frequency.

The study was single blind as patients although they were informed for the Electroacupuncture (E/A) technique during the first session they were anesthetized and the second one was after the awakening of anesthesia and they didn't understand it. On the other hand anaesthesiologists and the certified acupuncturist during the EAc application knew in which group patients belong although they did not deal with them postoperatively. However, patient assessments were performed at standard time points as 45 min in recovery and at 2 h, 6 h, 12 h and 24 h after surgery in the ward by another anaesthesiologist who was not present during the surgery or the recovery room for the first 30 min.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526525

Locations
Greece
G.Gennimatas GENERAL HOSPITAL OF THESSALONIKI
Thessaloniki, Greece, 54635
Sponsors and Collaborators
G.Gennimatas General Hospital
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: VAGIA NTRITSOU G.Gennimatas General Hospital
Study Director: DIMITRIOS VASILAKOS Aristotle University Of Thessaloniki
Study Director: GEORGIOS DIMITRIADIS G.Gennimatas General Hospital
Principal Investigator: CHRISTOS KOSTOGLOU, MD G.Gennimatas General Hospital
  More Information

No publications provided by G.Gennimatas General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NTRITSOU VAGIA, MD, ANESTHESIOLOGIST, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier: NCT01526525     History of Changes
Other Study ID Numbers: 6151/ 22-7-2009
Study First Received: January 28, 2012
Last Updated: February 20, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by G.Gennimatas General Hospital:
tramadol
ketamine
parecoxib
paracetamol
numerical rating scale (NRS)
McGill (SF-MPQ)
electronic pressure algometer
Spielberger State Trait Anxiety Inventory STAI Y-6 item

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Acetaminophen
Ketamine
Parecoxib
Tramadol
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents

ClinicalTrials.gov processed this record on November 25, 2014