Back to resultsTAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Magnesium Sulfate
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring magnesium sulfate, postoperative pain, TAP block, total abdominal hysterectomy
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Magnesium group
control group
Arm Description
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.
patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.
Outcomes
Primary Outcome Measures
total postoperative morphine consumption
total amount of rescue morphine consumption in the first 24 hours postoperatively
Secondary Outcome Measures
postoperative pain
postoperative pain measured by VAS score recorded in the first 24 hours postoperatively
first request of rescue analgesia
time to the first requirement of rescue analgesia during the first 24 hours postoperatively
side effects
occurrence of side effects during the first 24 hours postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02930707
Brief Title
TAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy
Official Title
Efficacy and Safety of Magnesium Sulfate Added to Local Anesthetic in TAP Block for Postoperative Analgesia Following Total Abdominal Hysterectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
magnesium sulfate, postoperative pain, TAP block, total abdominal hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.
Primary Outcome Measure Information:
Title
total postoperative morphine consumption
Description
total amount of rescue morphine consumption in the first 24 hours postoperatively
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
postoperative pain
Description
postoperative pain measured by VAS score recorded in the first 24 hours postoperatively
Time Frame
postoperative 24 hours
Title
first request of rescue analgesia
Description
time to the first requirement of rescue analgesia during the first 24 hours postoperatively
Time Frame
postoperative 24 hours
Title
side effects
Description
occurrence of side effects during the first 24 hours postoperatively
Time Frame
postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
29149143
Citation
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.
Results Reference
derived
Learn more about this trial
TAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy
We'll reach out to this number within 24 hrs