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Enhanced recovery after ear, nose and throat surgery is based on multimodal and multidisciplinary perioperative interventions to decrease postoperative pain. Functional endoscopic sinus surgery is a surgical management for chronic rhinosinusitis. Although a common procedure, there is a lack of knowledge about perioperative pain and specific pain management after such a procedure. Most of recommendations given in guidelines for postoperative pain management in nasal surgery and sinus surgery are subsumed under head and neck surgery. Head and neck surgery is a wide field covering widely variable surgical procedures. So, postoperative pain management guidelines may not meet the requirements for pain management during and after endoscopic sinus surgery.
Various medications have been used to improve the surgical field and postoperative pain including intravenous clonidine, dexmedetomidine, lidocaine, and magnesium.
Lidocaine has been used considering its analgesic, immuno-modulating, and anti-inflammatory properties. The opioid sparing effect of lidocaine is supported by a high level of evidence. The effectiveness of lidocaine infusion in obtaining reduction of postoperative pain, gastrointestinal recovery time, postoperative nausea and vomiting, and shortening the hospital length of stay, was demonstrated principally in major gastro-intestinal surgery.
Magnesium sulfate is a good option in multimodal analgesia, as it stabilizes the cell membrane and intracytoplasmic organelles by mediating the activation of Na+-K+ ATPase and Ca++ ATPase enzymes, which have an important role in transmembrane ion exchange during the depolarization and repolarization phases. Moreover, magnesium inhibits the release of norepinephrine by blocking the N-type Ca++ channels at nerve endings.
Many studies were designed to prove the role of the analgesic effect of lidocaine and magnesium infusion. However, this is the first randomized controlled study to assess the effect of lidocaine infusion versus magnesium sulphate infusion on decreasing total fentanyl requirements in patients undergoing functional endoscopic sinus surgery.
This randomized controlled trial was designed to compare the efficacy of lidocaine hydrochloride infusion versus magnesium sulphate infusion in controlling perioperative pain in patients undergoing functional endoscopic sinus surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Active Comparator | Patients received 2 mg/kg/h lidocaine hydrocloride starting at induction of anesthesia and continuing until the end of surgery |
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| Group M | Active Comparator | Patients received magnesium sulphate 20 mg/kg/h starting at induction of anesthesia and continuing until the end of surgery |
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| Group C | Sham Comparator | Patients received saline infusion starting at induction of anesthesia and continuing until the end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine group | Drug | 25ml of lidocaine hydrochloride 2% will be added to 25 ml of standard saline 0.9% solution in a 50ml syringe to be infused via a syringe pump. The resultant concentration will be 10mg/ml. According to the calculated study drug dose, each patient will receive 0.2ml/kg/h |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative fentanyl consumption | total fentanyl consumption during surgery | for 5 hours starting from induction of general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative mean arterial blood pressure | mean arterial blood pressure during surgery | for 5 hours starting from induction of general anesthesia |
| Intraoperative heart rate | heart rate during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kareem MA Nawwar, M.D. | Contact | +201003878369 | drknawwar@cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Jehan Elkholy, M.D. | Cairo University | Study Chair |
| Kareem MA Nawwar, M.D. | Cairo University | Study Director |
| Dina M Mohamed, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Cairo University | Cairo | Egypt |
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|
| Magnesium group | Drug | a 50ml syringe will be filled with magnesium sulfate solution (100mg/ml) to be infused via a syringe pump. According to the calculated study drug dose, each patient will receive 0.2ml/kg/h |
|
| Control group | Drug | a 50ml syringe will be filled with a standard saline 0.9% solution to be infused via a syringe pump. Each patient will receive 0.2ml/kg/h |
|
| for 5 hours starting from induction of general anesthesia |
| Clarity of the surgical field | Clarity of the surgical field according to Fromme and Boezaart scale (grade 0 means no bleeding and grade 5 means High bleeding, so constant blood evacuation is needed) | for 5 hours starting from induction of general anesthesia |
| Surgeon satisfaction | Surgeon satisfaction assessed at the end of the operation on a 5-point Likert satisfaction scale (grade 1 means Extremely dissatisfied and grade 5 means Extremely satisfied) | for 5 hours starting from induction of general anesthesia |
| Cairo University |
| Study Director |
| Dalia G Abdel Nasser, M.B.B.Ch. | Cairo University | Principal Investigator |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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