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

Assiut University

Status and phase: Unknown; Phase 2

Conditions: Rotator Cuff Tear

Treatments: Drug: Bupivacaine 0.5%; Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000; Drug: Nalbuphine; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03034382

SH1

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

Morphine

Experimental group

Description:

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

Treatment:

Drug: Morphine

Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Nalbuphine

Experimental group

Description:

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

Treatment:

Drug: Nalbuphine

Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Morphine and Nalbuphine

Experimental group

Description:

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

Treatment:

Drug: Nalbuphine

Drug: Morphine

Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Bupivacaine 0.5%

Placebo Comparator group

Description:

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

Treatment:

Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000

Drug: Bupivacaine 0.5%