NCT03363425

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

12 months

First QC Date

November 23, 2017

Last Update Submit

December 6, 2017

Conditions

HysterectomyMyomectomy

Keywords

DexmedetomidineLidocainePostoperative PainAnalgesic ConsumptionRecoveryAbdominal Gynaecological Surgery

Outcome Measures

Primary Outcomes (1)

  • analgesic consumption 24 hours postop

    morphine consumption from PCA

    24 hours postoperatively

Secondary Outcomes (6)

  • postoperative pain

    0 hours postoperatively

  • postoperative pain

    2 hours postoperatively

  • postoperative pain

    4 hours postoperatively

  • postoperative pain

    8 hours postoperatively

  • postoperative pain

    24 hours postoperatively

  • +1 more secondary outcomes

Study Arms (3)

Lidocaine

ACTIVE COMPARATOR
Drug: Lidocaine Iv

Dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Normal Saline 0,9%

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

Lidocaine IvDRUG

Lidocaine Iv

Lidocaine
DexmedetomidineDRUG

dexmedetomidine iv

Dexmedetomidine
Normal salineDRUG

placebo

Normal Saline 0,9%

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women
  • ASA I-II
  • years
  • abdominal gynaecological surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieio University Hospital

Athens, Greece

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35167059DERIVED

  • 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.

    PMID: 34704710DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anaesthesiology

Study Record Dates

First Submitted

November 23, 2017

First Posted

December 6, 2017

Study Start

November 14, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

December 8, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)