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TAP Block in Laparoscopic Cholecystectomy.

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ClinicalTrials.gov Identifier: NCT03612947
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Seham Mohamed Moeen Ibrahim, Assiut University

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivacaine +magnesium sulphate Drug: Bupivacaine only Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Magnesium Sulfate When Added to TAP Block With Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy.
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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

Placebo Comparator: Bupivacaine only
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).
Drug: Bupivacaine only
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612947


Contacts
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Contact: Seham M Moeen, MD 2413201 ext 088 seham.moeen@yahoo.com

Locations
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Egypt
Faculty of Medicine Assuit University Recruiting
Assiut, Asyut, Egypt, 71516
Contact: Seham M Moeen, MD    2413201 ext 088    seham.moeen@yahoo.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Seham Mohamed Moeen Ibrahim, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03612947     History of Changes
Other Study ID Numbers: 52018
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Magnesium Sulfate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents