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

Study Overview
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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.

Official Title
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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

Conditions
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Hysterectomy, Myomectomy

Intervention / Treatment
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* Drug: Lidocaine Iv
* Drug: Dexmedetomidine
* Drug: Normal saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br> | Drug: Lidocaine Iv<br>* Lidocaine Iv<br>|
| Active Comparator: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* dexmedetomidine iv<br>|
| Placebo Comparator: Normal Saline 0,9%<br> | Drug: Normal saline<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption 24 hours postop | morphine consumption from PCA | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 0 hours postoperatively | 
| postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 2 hours postoperatively | 
| postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 4 hours postoperatively | 
| postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 8 hours postoperatively | 
| postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 24 hours postoperatively | 
| postoperative pain | Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever) | 48 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Lidocaine, Postoperative Pain, Analgesic Consumption, Recovery, Abdominal Gynaecological Surgery