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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator |
| |
| Dexmedetomidine | Active Comparator |
| |
| Normal Saline 0,9% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Iv | Drug | Lidocaine Iv |
| |
| Dexmedetomidine |
| Measure | Description | Time Frame |
|---|---|---|
| analgesic consumption 24 hours postop | morphine consumption from PCA | 24 hours postoperatively |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aretaieio University Hospital | Recruiting | Athens | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35167059 | Derived | 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. | |
| 34704710 |
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| Drug |
dexmedetomidine iv |
|
| Normal saline | Drug | placebo |
|
| 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 |
| 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. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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