TAP Block in Laparoscopic Cholecystectomy.

Assiut University

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Bupivacaine only; Drug: Bupivacaine +magnesium sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT03612947

52018

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Bupivacaine +magnesium sulphate

Active Comparator group

Description:

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4.

Treatment:

Drug: Bupivacaine +magnesium sulphate

Bupivacaine only

Placebo Comparator group

Description:

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).

Treatment:

Drug: Bupivacaine only