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Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block

NCT ID: NCT05397236

Last Updated: 2022-05-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-02-01

Brief Summary

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The goal of postoperative pain management is the provision of comfort, early mobilization and improved respiratory function without causing inadequate sedation and respiratory compromise, which can be achieved through using regional anethesia.

This study aimed to assess the analgesic effect of adding dexamethasone or magnesium sulphate with bupivacaine in ultrasound-guided QLB to prolong its duration in patients undergoing open abdominal surgeries in the early postoperative period regarding pain relief After approval of the ethical committees in Ain Shams University Hospitals, patients undergoing open abdominal surgeries were included in the study, and were divided into three groups (n=22; each); group M, D and group C. In Group A, patients (n=22) received 20 ml bupivacaine 0.25% plus 5 ml of 10% MgSO. In group B, patients (n=22) received 20 ml bupivacaine 0.25% plus 8 mg dexamethasone (2 ml) plus 3 ml 0.9% NaCl. In group C (control), patients (n=22) received 20 ml bupivacaine plus 5 ml 0.9% NaCl.

Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bupivacaine Magnesium sulphate group

Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.

Group Type ACTIVE_COMPARATOR

Bupivacaine- Magnesium

Intervention Type DRUG

Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.

Bupivacaine Dexamethasone group

Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS.

Group Type ACTIVE_COMPARATOR

Bupivacaine dexamethasone

Intervention Type DRUG

Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS.

bupivacaine saline group

Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.

Group Type ACTIVE_COMPARATOR

Bupivacaine saline

Intervention Type DRUG

Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.

Interventions

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Bupivacaine- Magnesium

Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.

Intervention Type DRUG

Bupivacaine dexamethasone

Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS.

Intervention Type DRUG

Bupivacaine saline

Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) physical status I or II
* aged 18 to 65 years
* body weight ≥ 60 kg and ≤ 90 kg
* scheduled for open abdominal surgeries

Exclusion Criteria

* Patients' refusal to participate in the study
* history of allergy to the medications used in the study
* hepatic disease
* renal disease
* known neurologic disorders
* psychiatric disorder
* chronic treatment with calcium channel blockers
* hyper-magnesemia
* coagulopathy
* anatomical abnormalities
* hemodynamic instability
* local infection
* suspected intra- abdominal sepsis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ghada M.Samir

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain-Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MS 256/2021

Identifier Type: -

Identifier Source: org_study_id