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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03363425

Enrollment

Registered

2017-12-06

Start date

2017-11-14

Completion date

2018-11-30

Last updated

2017-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy, Myomectomy

Keywords

Dexmedetomidine, Lidocaine, Postoperative Pain, Analgesic Consumption, Recovery, Abdominal Gynaecological Surgery

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.

Interventions

DRUGLidocaine Iv

Lidocaine Iv

DRUGDexmedetomidine

dexmedetomidine iv

DRUGNormal saline

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
analgesic consumption 24 hours postop	24 hours postoperatively	morphine consumption from PCA

Secondary

Measure	Time frame	Description
postoperative pain	0 hours postoperatively	Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026