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

Primary Purpose

Hysterectomy, Myomectomy

Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Lidocaine Iv
Dexmedetomidine
Normal saline
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hysterectomy focused on measuring Dexmedetomidine, Lidocaine, Postoperative Pain, Analgesic Consumption, Recovery, Abdominal Gynaecological Surgery

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Aretaieio University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Dexmedetomidine

Normal Saline 0,9%

Arm Description

Outcomes

Primary Outcome Measures

analgesic consumption 24 hours postop
morphine consumption from PCA

Secondary Outcome Measures

postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)

Full Information

First Posted
November 23, 2017
Last Updated
December 6, 2017
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03363425
Brief Title
Effect of Perioperative iv Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption and Recovery After Abdominal Gynaecological Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterectomy, Myomectomy
Keywords
Dexmedetomidine, Lidocaine, Postoperative Pain, Analgesic Consumption, Recovery, Abdominal Gynaecological Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Title
Normal Saline 0,9%
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine Iv
Intervention Description
Lidocaine Iv
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
dexmedetomidine iv
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
placebo
Primary Outcome Measure Information:
Title
analgesic consumption 24 hours postop
Description
morphine consumption from PCA
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
postoperative pain
Description
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time Frame
0 hours postoperatively
Title
postoperative pain
Description
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time Frame
2 hours postoperatively
Title
postoperative pain
Description
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time Frame
4 hours postoperatively
Title
postoperative pain
Description
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time Frame
8 hours postoperatively
Title
postoperative pain
Description
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time Frame
24 hours postoperatively
Title
postoperative pain
Description
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time Frame
48 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Aretaieio University Hospital
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Rekatsina
Phone
00306975104139
Email
mrekatsina@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35167059
Citation
Rekatsina M, Theodosopoulou P, Staikou C. Perioperative Dexmedetomidine or Lidocaine Infusion for the Prevention of Chronic Postoperative and Neuropathic Pain After Gynecological Surgery: A Randomized, Placebo-Controlled, Double-Blind Study. Pain Ther. 2022 Jun;11(2):529-543. doi: 10.1007/s40122-022-00361-5. Epub 2022 Feb 15.
Results Reference
derived
PubMed Identifier
34704710
Citation
Rekatsina M, Theodosopoulou P, Staikou C. Effects of Intravenous Dexmedetomidine Versus Lidocaine on Postoperative Pain, Analgesic Consumption and Functional Recovery After Abdominal Gynecological Surgery: A Randomized Placebo-controlled Double Blind Study. Pain Physician. 2021 Nov;24(7):E997-E1006.
Results Reference
derived

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

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