Pain, Postoperative Clinical Trial
Official title:
Effect of Perioperative Electroacupuncture With Tramadol and Ketamine on Postoperative Analgesia in Prostatectomy: a Randomized Placebo-controlled Trial
Verified date | February 2014 |
Source | G.Gennimatas General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | February 2012 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | G.Gennimatas GENERAL HOSPITAL OF THESSALONIKI | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
G.Gennimatas General Hospital | Aristotle University Of Thessaloniki |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | 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 | Yes |
Primary | 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 | Yes |
Primary | 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 | Yes |
Primary | 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) | Yes |
Secondary | PATIENTS WELLBEING, | Spielberger State Trait Anxiety Inventory (STAI Y-6 item) 1-4, where 1=not at all and 4 =very much so. | Preoperatively and 24h following the surgery | Yes |
Secondary | SATISFACTION | Verbal Rating Scale (VRS) with 6 levels of satisfaction 1-6,from 1=very dissatisfied to 6= very satisfied | 24h following the surgery | Yes |
Secondary | SLEEP DISORDERS | Answer to questions such as "if they slept well?" yes/no "they had nightmares or bad dreams?" yes/no | 24h following the surgery | Yes |
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