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

• ClinicalTrials.gov Identifier: NCT03034382
• Recruitment Status: Unknown
• First Posted: January 27, 2017
• Last Update Posted: May 22, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): Shimaa Abbas Hassan, Assiut University

Tracking Information

• First Submitted Date: January 19, 2017
• First Posted Date: January 27, 2017
• Last Update Posted Date: May 22, 2017
• Study Start Date: January 2016
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2017)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 26, 2017)

• duration of analgesia [ Time Frame: 72 hours followup ]
  duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.
• 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).
• The first time to ask for analgesics [ Time Frame: 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).
• 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.
• itching [ Time Frame: 72 hours followup ]
  Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries
• Official Title: Adjuvants to Ultrasonic Guided Interscalene Block In Arthroscopic Rotator Cuff Repair; Morphine and/or Nalbuphine
• Brief Summary: 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Rotator Cuff Tear

Intervention

• 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 Name: morphine sulphate
• 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 Name: nubain
• 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 Name: Marcaine HCL
• 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 Name: lidocaine HCL and Adrenaline

Study Arms

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

  • Drug: Morphine
  • Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
• Experimental: Nalbuphine
  5 mg nalbuphine in 5ml volume injected as adjuvants to 10 ml of lidocaine and epinephrine 1:400,000.
  Interventions:

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

  Interventions:

  • Drug: Morphine
  • Drug: Nalbuphine
  • Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000
• 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.
  Interventions:

  • Drug: Bupivacaine 0.5%
  • Drug: Lidocaine Hydrochloride 1% and epinephrine 1:400,000

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 26, 2017): 80
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: June 2017
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03034382
• Other Study ID Numbers: SH1
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Shimaa Abbas Hassan, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Assiut University
• Verification Date: May 2017