TAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy

Study Overview
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Brief Summary
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Major abdominal surgeries are associated with severe abdominal pain, which can affect respiratory and cardiac functions, if insufficiently managed. This increases the incidence of post-operative morbidity. The objective of this study was to detect the efficacy and safety of magnesium sulphate as an adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in patients undergoing total abdominal hysterectomy.

Official Title
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Efficacy and Safety of Magnesium Sulfate Added to Local Anesthetic in TAP Block for Postoperative Analgesia Following Total Abdominal Hysterectomy.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: weight: 50- 85 kg. ASA score: I-III scheduled for total abdominal hysterectomy Exclusion Criteria: history of relevant drug allergy. coagulation disorders. opioid dependence. sepsis. psychiatric illnesses that would interfere with perception and assessment of pain.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium group<br>patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulphate 10% (200 mg), on each side of the abdominal wall. | Drug: Magnesium Sulfate<br>* ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulfate 10% (200 mg), on each side of the abdominal wall.<br>|
| Placebo Comparator: control group<br>patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall. | Drug: Bupivacaine<br>* ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total postoperative morphine consumption | total amount of rescue morphine consumption in the first 24 hours postoperatively | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | postoperative pain measured by VAS score recorded in the first 24 hours postoperatively | postoperative 24 hours | 
| first request of rescue analgesia | time to the first requirement of rescue analgesia during the first 24 hours postoperatively | postoperative 24 hours | 
| side effects | occurrence of side effects during the first 24 hours postoperatively | postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnesium sulfate, postoperative pain, TAP block, total abdominal hysterectomy