Clinical trial NCT03363425: Effect of Perioperative iv Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption and Recovery After Abdominal Gynaecological Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hysterectomy
Myomectomy
Keywords: Dexmedetomidine
Lidocaine
Postoperative Pain
Analgesic Consumption
Recovery
Abdominal Gynaecological Surgery
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: analgesic consumption 24 hours postop
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: postoperative pain
timeFrame: 0 hours postoperatively
measure: postoperative pain
timeFrame: 2 hours postoperatively
measure: postoperative pain
timeFrame: 4 hours postoperatively
measure: postoperative pain
timeFrame: 8 hours postoperatively
measure: postoperative pain
timeFrame: 24 hours postoperatively
measure: postoperative pain
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio University Hospital
Study officials:
References:
citation: 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.
citation: 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.