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Clinical Trials/NCT03363425
NCT03363425
Unknown
Phase 2

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

University of Athens1 site in 1 country60 target enrollmentNovember 14, 2017

Overview

Phase
Phase 2
Intervention
Lidocaine Iv
Conditions
Hysterectomy
Sponsor
University of Athens
Enrollment
60
Locations
1
Primary Endpoint
analgesic consumption 24 hours postop
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 14, 2017
End Date
November 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Athens
Responsible Party
Principal Investigator
Principal Investigator

Staikou Chryssoula

Assistant Professor of Anaesthesiology

University of Athens

Eligibility Criteria

Inclusion Criteria

  • 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

Arms & Interventions

Lidocaine

Intervention: Lidocaine Iv

Dexmedetomidine

Intervention: Dexmedetomidine

Normal Saline 0,9%

Intervention: Normal saline

Outcomes

Primary Outcomes

analgesic consumption 24 hours postop

Time Frame: 24 hours postoperatively

morphine consumption from PCA

Secondary Outcomes

  • postoperative pain(48 hours postoperatively)

Study Sites (1)

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