Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries

May 19, 2017 updated by: Shimaa Abbas Hassan, Assiut University

Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine

the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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.

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 (Anticipated)

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.
80

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.
  • Phase 2

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.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Assiut University Hospitals
        • Contact:

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder.
  • ASA physical status I - Ш.

Exclusion Criteria:

  • Infection at the site of injection.
  • Coagulopathy or other bleeding diathesis.
  • Known allergy to drugs in the study
  • Preexisting neurologic deficits in the area to be blocked.
  • Inability to communicate with the investigator and the hospital staff.
  • History of chronic opioid use.
  • Morbid obesity BMI>40.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Experimental: Morphine
5 mg morphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
Drug: Morphine
5 mg morphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Other Names:
  • morphine sulphate
Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Other Names:
  • lidocaine HCL and Adrenaline
Experimental: Nalbuphine
5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Other Names:
  • lidocaine HCL and Adrenaline
Drug: Nalbuphine
5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Other Names:
  • nubain
Experimental: Morphine and Nalbuphine

5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.

combination of 5 mg morphine and 5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Drug: Morphine
5 mg morphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Other Names:
  • morphine sulphate
Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Other Names:
  • lidocaine HCL and Adrenaline
Drug: Nalbuphine
5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
Other Names:
  • nubain
Placebo Comparator: Bupivacaine 0.5%
10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block.
Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
Other Names:
  • lidocaine HCL and Adrenaline
Drug: Bupivacaine 0.5%
10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block
Other Names:
  • Marcaine HCL

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
the total number of analgesic requests
Time Frame: 72 hours postoperative followup
the combination of opioid agonist and mixed agonist-antagonist peripherally prevents the development of early tolerance of the opioid agonist; thus the agonist would maintain the same efficacy and this will be obvious clinically by a reduction in the requests for supplementary analgesia.
72 hours postoperative followup

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
duration of analgesia
Time Frame: 72 hours followup
duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.
72 hours followup
patient satisfaction
Time Frame: 72 hours followup
- The patient satisfaction score. Patients were also asked to rate their satisfaction with the analgesia on a scale of 0-10 (0 for total dissatisfaction to 10 for total satisfaction).
72 hours followup
The first time to ask for analgesics
Time Frame: 72 hours followup
72 hours followup
sedation score
Time Frame: 72 hours followup
recorded every 4 hours; ranging from alert, drowsy, sleeping but responsive to verbal commands up to unarousable (we consider sedation score 3 or more as clinically significant sedation that mandate close patient observation every hour).
72 hours followup
number of vomiting attacks
Time Frame: 72 hours followup
recorded every 4 hours. A vomiting attack was defined by events of vomiting that occurred in a rapid sequence (<1 minute between events). If vomiting was separated by more than 1 minute; they will be considered to be separate attacks. Retching (the same as vomiting but without expulsion of gastric contents) was considered as vomiting. If the patient experienced vomiting; ondansetron 4 mg IV was given.
72 hours followup
itching
Time Frame: 72 hours followup
Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).
72 hours followup

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 Chair: Mahmoud A Aly, Prof, Assiut University Hospitals
  • Study Chair: Kawser H Mohammed, Prof, Assiut University Hospitals
  • Study Director: Ayman A Mamdouh, Ass Prof, Assiut University Hospitals

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

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.
January 1, 2016

Primary Completion (Actual)

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.
May 1, 2017

Study Completion (Anticipated)

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.
June 1, 2017

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).
January 19, 2017

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.
January 26, 2017

First Posted (Estimate)

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.
January 27, 2017

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.
May 22, 2017

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.
May 19, 2017

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.
May 1, 2017

More Information

Terms related to this study

Keywords

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.
  • SH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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