Effect of Perioperative iv Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption and Recovery After Abdominal Gynaecological Surgery

December 6, 2017 updated by: Staikou Chryssoula, University of Athens

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • Aretaieio University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
Drug: Lidocaine Iv
Lidocaine Iv
Active Comparator: Dexmedetomidine
Drug: Dexmedetomidine
dexmedetomidine iv
Placebo Comparator: Normal Saline 0,9%
Drug: Normal saline
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesic consumption 24 hours postop
Time Frame: 24 hours postoperatively
morphine consumption from PCA
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: 0 hours postoperatively
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
0 hours postoperatively
postoperative pain
Time Frame: 2 hours postoperatively
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
2 hours postoperatively
postoperative pain
Time Frame: 4 hours postoperatively
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
4 hours postoperatively
postoperative pain
Time Frame: 8 hours postoperatively
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
8 hours postoperatively
postoperative pain
Time Frame: 24 hours postoperatively
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
24 hours postoperatively
postoperative pain
Time Frame: 48 hours postoperatively
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

December 8, 2017

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EE-2/04/31-01-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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