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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03363425
Other study ID # EE-2/04/31-01-2017
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received November 23, 2017
Last updated December 6, 2017
Start date November 14, 2017
Est. completion date November 2018

Study information

Verified date December 2017
Source University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine Iv
Lidocaine Iv
Dexmedetomidine
dexmedetomidine iv
Normal saline
placebo

Locations

Country Name City State
Greece Aretaieio University Hospital Athens

Sponsors (1)

Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

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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