TAP Block in Laparoscopic Cholecystectomy.

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Bupivacaine +magnesium sulphate	Bupivacaine +magnesium sulphate	Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4.
Bupivacaine only	Bupivacaine only	Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).

Primary Outcome Measures

Name	Time	Method
The postoperative pain	The first 24 hours after surgery	Visual analogue pain score ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain.

Secondary Outcome Measures

Name	Time	Method
Time to first dose of post-operative analgesia	First occurrence during hospitalization (up to 24 hours postoperatively)	hours
Postoperative nausea and vomiting	The first 24 hours after surgery	A three-point rating scale (1: no postoperative nausea and vomiting, 2: nausea without vomiting, 3: nausea with vomiting).
postoperative sedation	The first 24 hours after surgery	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.
Patient satisfaction	At 24 hours after surgery	Patient satisfaction score ranged from 0-100 points; with 0 indicating the worst level of satisfaction and 100 indicating the best level of satisfaction.

Locations (1): Faculty of Medicine Assuit University
🇪🇬
Assiut, Asyut, Egypt

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