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Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic cholecystectomy.
After approval of local ethical committee, consent will be obtained from 90 patients scheduled for laparoscopic cholecystectomy in GEC center, Mansoura University, Egypt. Patients will be of either ASA I and II, with Age ranging from 18-40 years, and BMI less than 35. Patients will be randomized into 3 groups (using closed envelope technique in blocks of 18); Controlled group (C group), Bupivacaine group (B group), Bupivacaine Magnesium group (M group).
Anesthesia induction will be the same in the three groups (Propofol 1-1.5mglkg, Fentanyl 1 mic/kg, Atracrium 0.5 mg/kg) then Sevoflorane inhalational anesthesia for maintainace in 0.4 oxygen/air mixtures.
In both M group and B group, preemptive US guided Subcostal TAP block (Toshiba Xario, Japan) was performed on both sides using 20 ml volume (0.25 Bupivacaine in B group or 0.25 Bupivacaine plus 0.5 gm MgSo4 in M group). Surgical sterilization will be started 5 minutes after the block and surgery started5 minutes later. Hemodynamic data (HR, MAP) will be collected immediately after induction, at start of surgery, and each 10 minutes later.
At the end of surgery, and after closure of surgical ports, anesthesia was terminated and extubation done when patients fulfilled the required criteria. Postoperative hemodynamic data (HR, MAP), VAS, and PONV will berecorded at 0, 1, 2, 6, 12, 24 hours after surgery, Ramsay sedation was recorded at 0, 1, 2, 6 hours postoperatively. Boluses of Morphine (0.02 mg/kg) will be given whenever VAS ≥4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium sulfate group | Experimental | US guided TAP with magnesium sulfate |
|
| B group | Experimental | TAP bupevecaine |
|
| C group | Placebo Comparator | control TAP saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | preemptive US guided TAP block will be done using Bupivacaine 0.25% plus 0.5 gm MgSo4 in M group). |
|
| Measure | Description | Time Frame |
|---|---|---|
| analgesia after laparoscopic cholecystectomy | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alrefaey Kandeel, MD | Contact | 00201008158591 | refa3ey2@yahioo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura university | Al Mansurah | Dkahleya | Egypt |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 19, 2016 | |
| Unrelease | Yes | |
| Release | Oct 25, 2016 | |
| Reset | Dec 13, 2016 | |
| Release | Feb 13, 2017 | |
| Reset | Mar 30, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 19, 2016 | Yes | |||
| Oct 25, 2016 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| bupevecaine | Drug | US guided TAP using Bupevecaine 0.25 % |
|
|
| saline | Drug | US guided TAP using placebo (saline) |
|
|
| Dec 13, 2016 |
| Feb 13, 2017 | Mar 30, 2017 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |