Adding Morphine to ESP Block in Management of Acute PMP

June 5, 2024 updated by: Hadir atef, Assiut University

The Effect of Adding Morphine as an Adjuvant to Local Anesthetic in Erector Spinae Plane Block on Management of Acute Post Mastectomy Pain : A Randomized Controlled Trial

The aim of the study is to determine the efficacy of adding morphine in two doses (3mg, 5mg) to erector spinae plane block in relieving acute post mastectomy pain

Study Overview

Status

Status

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

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Breast cancer is the most common cancer in women requiring surgery . Breast surgeries is one of the most common type of surgery performed worldwide . Of these patients 30% to 50% will report moderate to severe acute pain. Pain if underestimated and untreated will affect patient's recovery , hemostasis, and lead to delayed discharge from PACU and increase length of hospital stay.Variety of local and regional anesthetic procedures which include local anesthetic infiltration , field block , intercostal nerve block , brachial plexus block and thoracic epidural anesthesia for breast surgery have considard as well established option to provide analgesia ,reduce post operative pain score , reduce opioid requirement , decrease post operative nausea and vomiting ,decrease pulmonary complication and duration of stay in PACU and specific to breast surgery there is also some evidence that regional anesthesia may help attenuate the surgical stress response and indirectly contribute to tumor inhibition by reducing opioid usage which has been implicated in immunosuppression and cancer progression. Pectoralis nerve block , serratus anterior nerve block and paravertebral nerve block are used for breast surgery analgesia . pectoralis nerve block and paravertebral block entrenched in clinical practice , and both of these techniques are shown to be effective as analgesic after breast surgery . However these techniques have many drawbacks . For example after performing the pectoralis nerve block the spread of the local anesthetic may interfere with surgical field . Paravertebral block can cause pneumothorax and epidural or intra thecal injection of the local anesthetic. Erector spinae plane block (ESPB) is a relatively new technique that was first described by Forero et Al in 2016 , they found that administration of local anesthetic below the erector spinae muscle produce extensive sensory block over the ipsilateral thorax . Forero et Al proposed that the injected local anesthetic spread anteriorly through the costo transverse foramen to its site of action at the origin of dorsal and ventral rami .Various adjuvants such as morphine , clonidine ,fentanyl, dexamethasone ,epinephrine ,and dexemedetomidine have been used with local anesthetic for improving and prolonging the postoperative analgesia with encouraging result . Morphine is a potent opioid analgesic widely used for treatment of severe pain. sedation scales assess the level of consciousness through behavioral observation and/ or stimulation of the patient. Ramsay sedation scale classifies level of awareness into six categories, this scale has multiple advantages :it is reproducible ,easy executed and has good applicability. This has made the scale the most widely used to assess level of sedation .Several rating scales have been developed to measure quality of recovery after surgery and anaesthesia, but the most extensively used after surgery is the QoR-40 scale,a40-item questionnaire that provide a global score and subscore across five dimension :patient support, comfort, emotion, physical independence, and pain.

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.
60

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1/female patients aged from 18 to 60 years.
  • 2/ASA I -II
  • 3/Surgery is modified radical mastectomy

Exclusion Criteria:

  • 1/ASA more than II
  • 2/Patients with known allergy to study drugs
  • 3/Skin infection at site of needle puncture
  • 4/Coagulopathy
  • 5/Uncooperative patients

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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
this group will receive erector spinae plane block only(bupivicaine)
Procedure: erector spinae plane block
The ultrasound (US)-guided ESP block will be provided while the patient be in a seated position according to surgical site (right or left). Using high-frequency linear US transducer , the probe is placed in the longitudinal orientation lateral to thoracic third and six spinous processes ,then the trapezius muscle ,rhomboids major muscle and erector spinae muscle are identified and we will inject 20ml of 0.25% bupivacaine into interfacial plane below erector spinae muscle in one level (between T3and T6) ,alone in 1st group,with 3 mg morphine in 2nd group and 5 mg morphine in 3rd group
Experimental: Interventional 3mg
this group will receive erector spinae plane block (bupivicaine and 3mg morphine)
Procedure: erector spinae plane block
The ultrasound (US)-guided ESP block will be provided while the patient be in a seated position according to surgical site (right or left). Using high-frequency linear US transducer , the probe is placed in the longitudinal orientation lateral to thoracic third and six spinous processes ,then the trapezius muscle ,rhomboids major muscle and erector spinae muscle are identified and we will inject 20ml of 0.25% bupivacaine into interfacial plane below erector spinae muscle in one level (between T3and T6) ,alone in 1st group,with 3 mg morphine in 2nd group and 5 mg morphine in 3rd group
Experimental: Interventional 5mg
this group will receive erector spinae plane block (bupivicaine and 5mg morphine)
Procedure: erector spinae plane block
The ultrasound (US)-guided ESP block will be provided while the patient be in a seated position according to surgical site (right or left). Using high-frequency linear US transducer , the probe is placed in the longitudinal orientation lateral to thoracic third and six spinous processes ,then the trapezius muscle ,rhomboids major muscle and erector spinae muscle are identified and we will inject 20ml of 0.25% bupivacaine into interfacial plane below erector spinae muscle in one level (between T3and T6) ,alone in 1st group,with 3 mg morphine in 2nd group and 5 mg morphine in 3rd group

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
total morphine consumption
Time Frame: during 24 hours post operative
. If the VAS score more than 3 rescue postoperative analgesia in the form of PCA morphine with initial bolus of 0.1mg/kg will be administered once the patient exhibit pain , followed by a 1 mg bolus with a locked period of 15 minutes when no background infusion will be permitted, total amount of morphine will be consumed be the patient will be recorded.
during 24 hours post operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time of first analgesic request
Time Frame: 2,4,6,8,12,24 hours post operative
time when the patient ask for analgesia post operative will be recorded
2,4,6,8,12,24 hours post operative
VAS at rest and movement
Time Frame: 2,4,6,8,12,24 hours post operative
the visual analoge scale(VAS) which was scored from 0 to 10 where 0 = no pain and 10= the worst pain imaginable,
2,4,6,8,12,24 hours post operative
Mean blood pressure (MBP)
Time Frame: Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative
Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative
Number of participants with morphine side effects
Time Frame: 2,4,6,8,12,24 hours post operative
2,4,6,8,12,24 hours post operative
Ramsay sedation scale
Time Frame: 2,4,6,8,12,24 hours post operative
Scale range from 1 (awake and alert) to 8 (unresponsive to external stimuli including pain)
2,4,6,8,12,24 hours post operative
Quality of recovery scale (QoR40)
Time Frame: at 24 hours post operative
From 1 to 5, where 1=very poor and 5= excellent
at 24 hours post operative
Heart rate (HR)
Time Frame: Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative
Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: shereen Mamdouh, south Egypt cancer institute ,Assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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.
September 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).
November 30, 2023

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.
December 16, 2023

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.
December 19, 2023

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.
June 6, 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.
June 5, 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.
June 1, 2024

More Information

Terms related to this study

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.
  • ESP block with morphine in PMP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings