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

NCT ID: NCT02930707

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

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.

control group

patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.

Interventions

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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.

Intervention Type DRUG

Bupivacaine

ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Mohammad Abd El-Rahman

lecturer of anesthesia,ICU, and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 29149143 (View on PubMed)

Other Identifiers

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177

Identifier Type: -

Identifier Source: org_study_id

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