Hysterectomy Clinical Trial
Official title:
Effect of Perioperative Intravenous Infusion of Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption, Bowel Function and Recovery After Abdominal Gynaecological Surgery: a Randomised Double Blind Study
Verified date | December 2017 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Postoperative pain continues to be inadequately managed and is the most common reason for the delay in discharge and unplanned hospital admission after surgery. Opioids remain the mainstay for postoperative analgesia. However, there is a continuous search for adjuvant therapies to reduce the doses of opioids and their related adverse effects, and extend the use of non-opioid analgesia for acute pain after abdominal surgery, thereby improving patient recovery. Currently there are no clinical trials that investigate the effect of intravenous lidocaine vs dexmedetomidine on postoperative pain, analgesic consumption and bowel function of patients undergoing abdominal gynaecological surgery. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of lidocaine vs dexmedetomidine vs placebo (Normal Saline 0,9%) on analgesic parameters and functional recovery of patients undergoing abdominal gynaecological surgery.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 70 Years |
Eligibility |
Inclusion Criteria: - women - ASA I-II - 30-70 years - abdominal gynaecological surgery Exclusion Criteria: - patient's refusal - contraindication to the use of local anesthetics - body mass index >30 kg/m2 - history of cardiovascular diseases/ arrhythmias/ conduction abnormalities - pregnant women - significant renal or hepatic impairment - insulin-dependent diabetes mellitus - central nervous system disease or psychiatric diseases - chronic use of opioids, steroids, clonidine (or other a2 agonist) - use of drugs acting on the central nervous system or analgesics during the previous 2 weeks - drug/alcohol abuse - inability to comprehend the following pain assessment scale |
Country | Name | City | State |
---|---|---|---|
Greece | Aretaieio University Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | analgesic consumption 24 hours postop | morphine consumption from PCA | 24 hours postoperatively | |
Secondary | postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 0 hours postoperatively | |
Secondary | postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 2 hours postoperatively | |
Secondary | postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 4 hours postoperatively | |
Secondary | postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 8 hours postoperatively | |
Secondary | postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 24 hours postoperatively | |
Secondary | postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 48 hours postoperatively |
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