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

Phase 2

• Conditions: Hysterectomy; Myomectomy
• Interventions: Drug: Normal saline; Drug: Lidocaine Iv; Drug: Dexmedetomidine

• Registration Number: NCT03363425
• Lead Sponsor: University of Athens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2017-11-23
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-06
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-08
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• women
• ASA I-II
• 30-70 years
• abdominal gynaecological surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline 0,9%	Normal saline	-
Lidocaine	Lidocaine Iv	-
Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
analgesic consumption 24 hours postop	24 hours postoperatively	morphine consumption from PCA

Secondary Outcome Measures

Name	Time	Method
postoperative pain	48 hours postoperatively	Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)

Trial Locations

Locations (1)

Aretaieio University Hospital; 🇬🇷 Athens, Greece