Effectiveness of Adding Hyaluronidase to Bupivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block

NCT05083663 | Unknown Phase 2 DMC

• 1 other identifier: Soh-Med-21.09.04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background Brachial plexus block is a good choice for surgeries of the upper limb because it provides good quality of anesthesia and analgesia especially in patients with multiple comorbidities and in ambulatory surgery. Hyalaluronidase is a local anesthetic adjuvant used for ophthalmologic surgery. We evaluated the effect of adding hyaluronidase to bupivacaine as regard the onset and duration of motor and sensory block in ultrasound guided supraclavicular brachial plexus block. Methodology prospective, randomized and double-blind study conducted at Sohag University Hospital. A total of 40 adults scheduled for upper limb surgery, ASA I or II were randomly assigned into two groups (n=20). Group I received bupivacaine 0.375 % 15 mL + normal saline 4ml +hyaluronidase 800 IUin 1 ml. Group II received bupivacaine 0.375% 15 mL + normal saline5 ml. Both groups will be compared for onset and duration of sensory and motor block, duration of analgesia and complications. Results The onset of sensory and motor block was significantly faster in hyaluronidase group than control group. Significant difference could not be detected in either duration of the sensory or motor block between the two groups. Conclusion The use of hyaluronidase as an additive to bupivacaine fastens the onset of sensory and motor block of the brachial plexus in supraclavicular approach without affecting the duration of the block.

Conditions

Postoperative Pain

Keywords

hyaluronidase; supraclavicular block; buivacaine; ultrasound

Outcome Measures

Primary Outcomes (2)

• Onset of complete sensory block

  time from injection to complete sensory block to pin prick

  during the first 24 hours

• Onset of complete motor block

  time from injection to complete motor block

  during the first 24 hours

Secondary Outcomes (4)

• duration of anlgesia

  during the first 24 hours

• Duration of sensory block

  during the first 24 hours

• duration of motor block

  during the first 24 hours

• side effects

  during the first 24 hours

Study Arms (2)

Group I

EXPERIMENTAL

received bupivacaine 0.375 % 15 mL + normal saline 4ml +hyaluronidase 800 IU in 1 ml.

Drug: Hyaluronidase

Group II

NO INTERVENTION

received bupivacaine 0.375% 15 mL + normal saline5 ml.

Interventions

Hyaluronidase DRUG

using hyaluronidase as an additive to bupivacaine

Group I

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18 to 60 years
• American Society of Anesthesiologists class I and II
• Scheduled for elective surgery of the upper extremities

You may not qualify if:

• allergy to local anesthetic or hyaluronidase
• Severe renal or hepatic disease
• Pulmonary, cardiac disease
• Neurologic, psychiatric disease
• Neuromuscular disease
• Pregnant or lactating women
• Morbid obesity
• Coagulation disorders as well

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, 82516, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hyaluronoglucosaminidase

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Central Study Contacts

Hitham M Elsayed, MD

CONTACT

00201029106541; haytham_elsayed@med.sohag.edu.eg

Mohammed A Mahroos, MD

CONTACT

00201091328413; mahroos_mohammed@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical ICU

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 19, 2021
• Study Start: September 10, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)