TAP Block in Laparoscopic Cholecystectomy.

Study Overview
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Brief Summary
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Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics.

Detailed Description
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A significant pain experienced by patients after laparoscopic cholecystectomy surgery is required so as to block nociceptive transmission from both the abdominal wall incision, and visceral sites. Using of opioids can result in significant adverse effects, thus delaying early mobilization of patients. Ultrasound-guided transversus abdominis plane (TAP) block has been used as a satisfactory approach that provides postoperative analgesia. TAP block is safe; it diminishes or replaces the use of opioids; and it has a lower incidence of adverse effects. Bupivacaine is a medication used to decrease feeling in a specific area. It is used by injecting it into the area, around a nerve that supplies the area, or into the spinal canal's epidural space. Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks. Magnesium is the fourth most plentiful cation in our body. It may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising. Magnesium sulphate (MgSO4), N-methyl-D-aspartate receptor antagonist has the potential to be an ideal adjuvant in TAP block.

Official Title
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Effect of Magnesium Sulfate When Added to TAP Block With Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Bupivacaine +magnesium sulphate
* Drug: Bupivacaine only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age: 18-65 years old) undergoing laparoscopic cholecystectomy. Exclusion Criteria: Patient refusal Patients with a history of cardiac, or respiratory diseases ( >ASA III). Patients with allergy to amide local anesthetics or medication included in the study. Infection at the needle insertion site. Pregnancy BMI >35 Drug abusers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine +magnesium sulphate<br>Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4. | Drug: Bupivacaine +magnesium sulphate<br>* Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4<br>|
| Placebo Comparator: Bupivacaine only<br>Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine). | Drug: Bupivacaine only<br>* Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postoperative pain | Visual analogue pain score ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain. | The first 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first dose of post-operative analgesia | hours | First occurrence during hospitalization (up to 24 hours postoperatively) | 
| Postoperative nausea and vomiting | A three-point rating scale (1: no postoperative nausea and vomiting, 2: nausea without vomiting, 3: nausea with vomiting). | The first 24 hours after surgery | 
| postoperative sedation | Ramsay sedation score as follows: (1) anxious and irritable or dysphoric or both; (2) co-operational, oriented and quiet; (3) responsive to command; (4) asleep, quickly responsive to light tap or loud auditory stimulus; (5) asleep, slowly responsive to light tap or loud auditory stimulus; and (6) asleep, no response to light tap or loud auditory stimulus. | The first 24 hours after surgery | 
| Patient satisfaction | Patient satisfaction score ranged from 0-100 points; with 0 indicating the worst level of satisfaction and 100 indicating the best level of satisfaction. | At 24 hours after surgery |