TAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy
Efficacy and Safety of Magnesium Sulfate Added to Local Anesthetic in TAP Block for Postoperative Analgesia Following Total Abdominal Hysterectomy.
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 postoperative-pain
Started Jan 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 10, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedOctober 12, 2016
October 1, 2016
5 months
October 10, 2016
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total postoperative morphine consumption
total amount of rescue morphine consumption in the first 24 hours postoperatively
postoperative 24 hours
Secondary Outcomes (3)
postoperative pain
postoperative 24 hours
first request of rescue analgesia
postoperative 24 hours
side effects
postoperative 24 hours
Study Arms (2)
Magnesium group
ACTIVE COMPARATORpatients 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.
control group
PLACEBO COMPARATORpatients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.
Interventions
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.
ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.
Eligibility Criteria
You may qualify if:
- weight: 50- 85 kg.
- ASA score: I-III
- scheduled for total abdominal hysterectomy
You may not qualify if:
- history of relevant drug allergy.
- coagulation disorders.
- opioid dependence.
- sepsis.
- psychiatric illnesses that would interfere with perception and assessment of pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Abd-Elsalam KA, Fares KM, Mohamed MA, Mohamed MF, El-Rahman AMA, Tohamy MM. Efficacy of Magnesium Sulfate Added to Local Anesthetic in a Transversus Abdominis Plane Block for Analgesia Following Total Abdominal Hysterectomy: A Randomized Trial. Pain Physician. 2017 Nov;20(7):641-647.
PMID: 29149143DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of anesthesia,ICU, and pain management
Study Record Dates
First Submitted
October 10, 2016
First Posted
October 12, 2016
Study Start
January 1, 2016
Primary Completion
June 1, 2016
Study Completion
November 1, 2016
Last Updated
October 12, 2016
Record last verified: 2016-10