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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03034382
• Other study ID #: SH1
• Status: Recruiting
• Phase: Phase 2
• First received: January 19, 2017
• Last updated: May 19, 2017
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: Shimaa A Husien, Msc
• Phone: 01002953253
• Email: shimo.9feb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder.

• ASA physical status I - ?.

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.

Related Conditions & MeSH terms

• 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
• 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
• Bupivacaine 0.5%
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
10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the total number of analgesic requests	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	duration of analgesia	duration of analgesia when morphine or nalbuphine or both used in interscalene block using VAS.	72 hours followup
Secondary	patient satisfaction	- 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
Secondary	The first time to ask for analgesics		72 hours followup
Secondary	sedation score	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
Secondary	number of vomiting attacks	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
Secondary	itching	Itching is assessed using an ordinal scale (0 = no itch, 1 = mild, 2 = moderate, 3 = severe).	72 hours followup