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

NCT ID: NCT03363425

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-14

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hysterectomy Myomectomy

Keywords

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Dexmedetomidine Lidocaine Postoperative Pain Analgesic Consumption Recovery Abdominal Gynaecological Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine

Group Type ACTIVE_COMPARATOR

Lidocaine Iv

Intervention Type DRUG

Lidocaine Iv

Dexmedetomidine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine iv

Normal Saline 0,9%

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

placebo

Interventions

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Lidocaine Iv

Lidocaine Iv

Intervention Type DRUG

Dexmedetomidine

dexmedetomidine iv

Intervention Type DRUG

Normal saline

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Staikou Chryssoula

Assistant Professor of Anaesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aretaieio University Hospital

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Facility Contacts

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Martina Rekatsina

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35167059 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34704710 (View on PubMed)

Other Identifiers

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EE-2/04/31-01-2017

Identifier Type: -

Identifier Source: org_study_id