Comparative Study of Ultrasound Guided Combined Interscalene and Supraclavicular Brachial Plexus Block Versus General Anesthesia for Brachioaxillary Surgery in Renal Failure Patient

NCT04050891 | Completed

• 1 other identifier: MS/17.08.26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of combined supraclavicular and interscalene brachial plexus block in brachio-axillary surgeries in chronic renal failure as a sole anesthetic technique in comparison to general anesthesia.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (4)

• Pain assessment by numerical rating scale

  was explained to all candidates (zero = no pain and 10 = the worst pain)

  24 hours after surgery

• satisfaction of the surgeon to the combined block supraclavicular and interscalene during operation

  by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied

  3 hours

• satisfaction of the patients to the combined block

  by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied

  3 hours

• graft potency

  by doppler

  up to one month after surgery

Secondary Outcomes (3)

• The onset and duration of sensory and motor block

  30 minutes after block

• time to first intravenous analgesic requirement

  24 hours after surgery

• Number of times of needed analgesia

  24 hours after surgery

Study Arms (2)

group GA (general anesthesia)

NO INTERVENTION

After pre-oxygenation general anesthesia was induced using 2mg/kg propofol, 1μg/kg of fentanyl. After loss of consciousness 0.5 mg/kg of atracurium was injected. The endotracheal tube (ETT) was placed and inflated. The patient was mechanically ventilated to adjust end tidal CO2 between 35 and 40mmHg, anesthesia was maintained using 1.2 % isoflurane diluted in 3L of 50 % oxygen mixed with air. Increments of fentanyl (0.5 μg/kg ) and atracurium 10 mg were used whenever required and the hemodynamic values were maintained within 20% of the basal values. At the end of surgery, residual muscle relaxant was reversed with 50µg/kg neostigmine and 0.02 mg/kg atropine.

group RA (regional anesthesia)

ACTIVE COMPARATOR

received combined supraclavicular and interscalene block.The mixture of anesthetic suolution was prepared by 20 ml isobaric bupivacaine 0.5% plus 10ml lidocaine 2% plus 10ml normal saline, total volume was 40ml which is devided into 25ml for suraclavicular block and 15ml for intersalene block

Device: combined supraclavicular and interscalene block

Interventions

combined supraclavicular and interscalene block DEVICE

Supraclavicular block An in plane approach, a 22G needle 75mm was advanced from lateral to medial to the corner pocket where the lower trunk commonly lies at this area between the subclavian artery medially, first rib inferiorly and the plexus superiorly then 10ml of the mixture local anesthetic was injected, the remaining volume was injected just above and lateral to the subclavian artery. Interscalene block After local anesthetic infiltration of the skin, a 22G needle 75mm was inserted in plane approach from lateral to medial toward the inter-scalene groove between the anterior and middle scalene muscles. The anesthetic mixture 15 ml was injected toward C5, C6 cervical nerve roots aiming to block nerves escaped from supraclavicular nerve block.

group RA (regional anesthesia)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• sixty patients of chronic renal failure,
• ASA III,
• aged from 20 to 60 years old
• of either sex
• planned for brachioaxillary graft interposition vascular surgery were enrolled.

You may not qualify if:

• Patients refusal,
• have allergy to local anesthetic,
• neurological, neuromuscular, psychiatric disorders,
• uncompensated hepatic, respiratory or cardiac disease,
• uncontrolled seizures,
• coagulation disorders,
• infection at the block injection site,
• body mass index more than 30

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Nevert adel

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Lecturer of Anesthesia and Surgical Intensive Care

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 8, 2019
• Study Start: June 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 10, 2019
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

EG (1)