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TAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy

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ClinicalTrials.gov Identifier: NCT02930707
Recruitment Status : Unknown
Verified October 2016 by Ahmad Mohammad Abd El-Rahman, Assiut University.
Recruitment status was:  Active, not recruiting
First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmad Mohammad Abd El-Rahman, Assiut University

Study Description
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Brief Summary:

Major abdominal surgeries are associated with severe abdominal pain, which can affect respiratory and cardiac functions, if insufficiently managed. This increases the incidence of post-operative morbidity.

The objective of this study was to detect the efficacy and safety of magnesium sulphate as an adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in patients undergoing total abdominal hysterectomy.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Magnesium Sulfate Drug: Bupivacaine Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Magnesium Sulfate Added to Local Anesthetic in TAP Block for Postoperative Analgesia Following Total Abdominal Hysterectomy.
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Magnesium group
patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulphate 10% (200 mg), on each side of the abdominal wall.
 Drug: Magnesium Sulfate
ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulfate 10% (200 mg), on each side of the abdominal wall.
Placebo Comparator: control group
patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.
 Drug: Bupivacaine
ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.


Outcome Measures
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Primary Outcome Measures :
  1. total postoperative morphine consumption [ Time Frame: postoperative 24 hours ]
    total amount of rescue morphine consumption in the first 24 hours postoperatively


Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: postoperative 24 hours ]
    postoperative pain measured by VAS score recorded in the first 24 hours postoperatively

  2. first request of rescue analgesia [ Time Frame: postoperative 24 hours ]
    time to the first requirement of rescue analgesia during the first 24 hours postoperatively

  3. side effects [ Time Frame: postoperative 24 hours ]
    occurrence of side effects during the first 24 hours postoperatively


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • weight: 50- 85 kg.
  • ASA score: I-III
  • scheduled for total abdominal hysterectomy

Exclusion Criteria:

  • history of relevant drug allergy.
  • coagulation disorders.
  • opioid dependence.
  • sepsis.
  • psychiatric illnesses that would interfere with perception and assessment of pain.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ahmad Mohammad Abd El-Rahman, lecturer of anesthesia,ICU, and pain management, Assiut University
ClinicalTrials.gov Identifier: NCT02930707    
Other Study ID Numbers: 177
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Keywords provided by Ahmad Mohammad Abd El-Rahman, Assiut University:
magnesium sulfate
postoperative pain
TAP block
total abdominal hysterectomy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Magnesium Sulfate
Bupivacaine
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