Perioperative Electroacupuncture on Postoperative Analgesia in Prostatectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Tramadol; Ketamine; Tramadol; Morphine; sedation; rescue analgesia; Parecoxib; paracetamol
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Procedure; Drug; Drug
Intervention description(s): 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®); 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.; 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; 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; 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.; 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.; An hour before the end of the surgery all patients were administered with parecoxib 40mg (IV); 30min before the end of the surgery paracetamol 20mg/kg (IV).
Intervention MeSH terms: Acetaminophen; Parecoxib; Ketamine; Morphine; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: tramadol; ketamine; parecoxib; paracetamol; numerical rating scale (NRS); McGill (SF-MPQ); electronic pressure algometer; Spielberger State Trait Anxiety Inventory STAI Y-6 item