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

National and Kapodistrian University of Athens

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Myomectomy; Hysterectomy

Treatments: Drug: Lidocaine Iv; Drug: Normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03363425

EE-2/04/31-01-2017

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Lidocaine

Active Comparator group

Treatment:

Drug: Lidocaine Iv

Dexmedetomidine

Active Comparator group

Treatment:

Drug: Dexmedetomidine

Normal Saline 0,9%

Placebo Comparator group

Treatment:

Drug: Normal saline