Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries

March 4, 2024 updated by: Martha Aweda Soliman, Assiut University

Effect of Adding Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia in Lower Abdominal Cancer Surgeries.

The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is vital to apply adequate postoperative analgesia following lower abdominal surgeries of cancer because Postoperative pain not only affects the patients' rest but also produces a series of pathological reactions. Postoperative analgesia, including regional anesthesia, is very important which not only provides effective postoperative analgesia but also reduces the need for postoperative opioids.In recent years, various ultrasound-guided regional anethetic techniques have been extensively used. One of them is Quadratus lumborum block which can provide postoperative analgesia of the segmental innervation from T6 to L1. In which the Local anesthetics can spread through the thoracolumbar fascia to the paravertebral space, thereby blocking part of the sympathetic nerves . Clinical studies have shown that compared with the current widely used transverse abdominal block, QLB provides longer analgesia and wider block levels when the same dose of local anesthetic is used unlike traditional trunk block, QLB cannot use the sense of falling during puncture and can only be performed under ultrasound guidance, which has the advantages of being real-time and dynamic. Ultrasound-guided nerve block provides more accurate positioning and benefits for patients with less injury. Magnesium sulfate plays an important role in the physiological function of the human body. A large number of studies have reported the safety and effectiveness of adding magnesium sulfate as an adjuvant in various regional anethetic techniques . Therefore, we designed a prospective randomized controlled trial to compare the analgesic efficacy of combining magnesium sulfate with bupivacaine in QLB.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age from 18 to 80 years old
  2. Both gender
  3. Weight from 55 to 85 kg
  4. ASA groups 2 and 3
  5. Lower abdominal cancer surgeries

Exclusion Criteria:

  • 1. Patient refusal 2. True local anesthetic allergy 3. Coagulopathy 4. Local infection at the procedure site 5. Psychic patients 6. Patient on chronic opioid use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control Group
receive pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine on each side of the abdominal wall before induction of GA.
Drug: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries
Bilateral ultrasound-guided transmuscular (anterior) quadratus lumborum block will be performed Each patient will be placed in the lateral position. the transducer will be placed in a transverse orientation on the flank just cranial to the iliac crest, then slide posteriorly to obtain an image of the quadratus lumborum muscle.echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle; the correct position of the needle tip will be confirmed by injecting 3 mL of saline to separate the fascial layers at the lateral aspect of the quadratus lumborum muscle. Thereafter, the needle will be advanced more posteriorly between the quadratus muscle and psoas major muscle
Experimental: InterventionalGroup
received pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine plus 2 ml of magnesium sulfate 10 % on each side of the abdominal wall before induction of GA.
Drug: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries
Bilateral ultrasound-guided transmuscular (anterior) quadratus lumborum block will be performed Each patient will be placed in the lateral position. the transducer will be placed in a transverse orientation on the flank just cranial to the iliac crest, then slide posteriorly to obtain an image of the quadratus lumborum muscle.echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle; the correct position of the needle tip will be confirmed by injecting 3 mL of saline to separate the fascial layers at the lateral aspect of the quadratus lumborum muscle. Thereafter, the needle will be advanced more posteriorly between the quadratus muscle and psoas major muscle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative analgesia
Time Frame: First 24 hrs postoperative
Total morphine consumption during first 24hr postoperative
First 24 hrs postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Quadratus lumborum block

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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