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Completed

NCT Number: NCT03612947

TAP Block in Laparoscopic Cholecystectomy.

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine Assuit University

Asyut, Asyut Governorate, 71516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine +magnesium sulphate

Drug

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

Bupivacaine Only

Drug

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

Primary outcomes

  1. The postoperative pain

    Time frame: 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 outcomes

  1. Time to first dose of post-operative analgesia

    Time frame: First occurrence during hospitalization (up to 24 hours postoperatively)

    hours

  2. Postoperative nausea and vomiting

    Time frame: 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).

  3. postoperative sedation

    Time frame: 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.

  4. Patient satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2018
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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