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Perioperative Electroacupuncture on Postoperative Analgesia in Prostatectomy

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ClinicalTrials.gov Identifier: NCT01526525
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : February 21, 2014
Sponsor:
Collaborator:
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
NTRITSOU VAGIA, MD, G.Gennimatas General Hospital

Tracking Information
First Submitted Date  ICMJE January 28, 2012
First Posted Date  ICMJE February 6, 2012
Last Update Posted Date February 21, 2014
Study Start Date  ICMJE July 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
  • PAIN SCALES [ Time Frame: 45min, 2h, 6h, 12h and 24h following the surgery ]
    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 ]
    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 ]
    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 ]
    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) ]
    Cortizol levels: ug/dl
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
  • PATIENTS WELLBEING, [ Time Frame: Preoperatively and 24h following the surgery ]
    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 ]
    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 ]
    Answer to questions such as "if they slept well?" yes/no "they had nightmares or bad dreams?" yes/no
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perioperative Electroacupuncture on Postoperative Analgesia in Prostatectomy
Official Title  ICMJE Effect of Perioperative Electroacupuncture With Tramadol and Ketamine on Postoperative Analgesia in Prostatectomy: a Randomized Placebo-controlled Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Tramadol
    • Drug: Ketamine
    • Drug: Tramadol
    • Drug: Morphine
    • Procedure: sedation
    • Procedure: rescue analgesia
    • Drug: Parecoxib
    • Drug: paracetamol
  • 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.
    Interventions:
    • Drug: Tramadol
    • Drug: Ketamine
    • Drug: Tramadol
    • Drug: Morphine
    • Procedure: sedation
    • Procedure: rescue analgesia
    • Drug: Parecoxib
    • Drug: paracetamol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2012)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01526525
Other Study ID Numbers  ICMJE 6151/ 22-7-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NTRITSOU VAGIA, MD, G.Gennimatas General Hospital
Study Sponsor  ICMJE G.Gennimatas General Hospital
Collaborators  ICMJE Aristotle University Of Thessaloniki
Investigators  ICMJE
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
PRS Account G.Gennimatas General Hospital
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP