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

NCT ID: NCT03034382

Last Updated: 2017-05-22

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

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rotator Cuff Tear

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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Morphine

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

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

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

Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Intervention Type DRUG

10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block

Nalbuphine

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

Group Type EXPERIMENTAL

Nalbuphine

Intervention Type DRUG

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

Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Intervention Type DRUG

10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block

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

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

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

Nalbuphine

Intervention Type DRUG

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

Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Intervention Type DRUG

10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block

Bupivacaine 0.5%

10 ml of lidocaine 1% and epinephrine 1:400,000 and 5 ml of Bupivacaine 0.5% in interscalene block.

Group Type PLACEBO_COMPARATOR

Bupivacaine 0.5%

Intervention Type DRUG

10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block

Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Intervention Type DRUG

10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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morphine sulphate nubain Marcaine HCL lidocaine HCL and Adrenaline

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Shimaa Abbas Hassan

Primary investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud A Aly, Prof

Role: STUDY_CHAIR

Assiut University Hospitals

Kawser H Mohammed, Prof

Role: STUDY_CHAIR

Assiut University Hospitals

Ayman A Mamdouh, Ass Prof

Role: STUDY_DIRECTOR

Assiut University Hospitals

Locations

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Assiut University Hospitals

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shimaa A Husien, Msc

Role: CONTACT

01002953253 ext. 002

Facility Contacts

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Ayman A Mamdouh, AssProf

Role: primary

01066066001 ext. 002

Other Identifiers

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SH1

Identifier Type: -

Identifier Source: org_study_id

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