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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Hyaluronidase
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain focused on measuring hyaluronidase, supraclavicular block, buivacaine, ultrasound

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group I

Group II

Arm Description

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

received bupivacaine 0.375% 15 mL + normal saline5 ml.

Outcomes

Primary Outcome Measures

Onset of complete sensory block
time from injection to complete sensory block to pin prick
Onset of complete motor block
time from injection to complete motor block

Secondary Outcome Measures

duration of anlgesia
time from injection to first analgesia request
Duration of sensory block
time between injection and complete recovery of sensation
duration of motor block
time between injection and complete recovery of motor power
side effects
hypotension, sedation, nausea vomiting, dry mouth, hematoma or pneumothorax, neuropathy

Full Information

First Posted
October 5, 2021
Last Updated
October 19, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05083663
Brief Title
Effectiveness of Adding Hyaluronidase to Bupivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block
Official Title
Effectiveness of Hyaluronidase as an Adjuvant to Bupivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block for Upper Limb Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This prospective, randomized, controlled and double-blind study was conducted at Sohag University Hospital after approval from institution review board and obtaining written informed consents from all participants. Forty participants, aged 18 to 60 years, American Society of Anesthesiologists class I and II, scheduled for elective surgery of the upper extremities were included in this study. Participants who refuse or have allergy to local anesthetic or hyaluronidase or suffering from severe renal, hepatic, pulmonary, cardiac, neurologic, psychiatric or neuromuscular disease will be excluded from the study in addition to pregnant or lactating women, patients with morbid obesity, coagulation disorders as well. Sealed envelopes technique was used to randomly assign patients to both study groups; Group I; received bupivacaine 0.375 % 15 mL + normal saline 4ml +hyaluronidase 800 IU in 1 ml. Group II; received bupivacaine 0.375% 15 mL + normal saline5 ml. After arriving to the operative theater basic monitoring was applied and intravenous line was inserted. Midazolam 2mg and Fentanyl 50 mcg was administered intravenously to all participants 15 minutes before the procedure. Anesthesiologist who carried out the block and recorded the study measurements was blinded to the treatment groups. The participants were in supine position with the head rotated to the opposite side and neck extended, 7 to 12 MHz linear ultrasound probe (SonoScape A5, SonoScape Co., Ltd., China) was placed above the clavicle to identify distal trunks or proximal divisions of the brachial plexus lateral and cephalad to the subclavian artery above the first rib. After ultrasound pre-scan and local infiltration with 3ml lidocaine 2%, 100 mm, 20 gauge nerve-stimulating needle (Locoplex®, VYGON, FRANCE) was inserted under real time ultrasound guided technique in line approach and advanced until reaching the brachial plexus sheath the needle was repositioned to allow local anesthetic spread around all trunks or divisions. Injection was stopped if an increased resistance to injection experienced or parathesia to avoid intra neural injection. All participants were transferred to post-anesthesia care unit postoperatively to be observed for the following measurements: The primary measurement: Onset of complete sensory block (time from injection to complete sensory block to pin prick). Onset of complete motor block (time from injection to complete motor block). Secondary measurements: Duration of analgesia defined as time from injection to first analgesia request. Duration of sensory block (time between injection and complete recovery of sensation) Duration of motor block (time between injection and complete recovery of motor power) Side effects and complications (hypotension, sedation, nausea vomiting, dry mouth, hematoma or pneumothorax, neuropathy) Participants were allowed to receive analgesia as ketorolac 30 mg intramuscularly as a rescue analgesia if VAS > 4. Statistical analysis: After performing the power analysis of the study , it is decided that each group should contain at least a minimum of 18 cases (90% power and 0.05%alpha error).Considering possible data loss due to technical reasons, each group was decided to be 20 patients. Recorded data were subjected to statistical analysis using Statistical Package for Social Sciences (SPSS), Student's t-test was used for statistical analysis of demographic and hemodynamic data while unpaired t-test was applied for onset time and duration of sensory and motor blocks and was reconfirmed with the Wilcoxon W and Mann-Whitney U tests. Statistical significance was defined by P-value < 0.05. chi-square/Fischer's exact test was used for analysis of adverse effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
hyaluronidase, supraclavicular block, buivacaine, ultrasound

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
received bupivacaine 0.375 % 15 mL + normal saline 4ml +hyaluronidase 800 IU in 1 ml.
Arm Title
Group II
Arm Type
No Intervention
Arm Description
received bupivacaine 0.375% 15 mL + normal saline5 ml.
Intervention Type
Drug
Intervention Name(s)
Hyaluronidase
Intervention Description
using hyaluronidase as an additive to bupivacaine
Primary Outcome Measure Information:
Title
Onset of complete sensory block
Description
time from injection to complete sensory block to pin prick
Time Frame
during the first 24 hours
Title
Onset of complete motor block
Description
time from injection to complete motor block
Time Frame
during the first 24 hours
Secondary Outcome Measure Information:
Title
duration of anlgesia
Description
time from injection to first analgesia request
Time Frame
during the first 24 hours
Title
Duration of sensory block
Description
time between injection and complete recovery of sensation
Time Frame
during the first 24 hours
Title
duration of motor block
Description
time between injection and complete recovery of motor power
Time Frame
during the first 24 hours
Title
side effects
Description
hypotension, sedation, nausea vomiting, dry mouth, hematoma or pneumothorax, neuropathy
Time Frame
during the first 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 18 to 60 years American Society of Anesthesiologists class I and II Scheduled for elective surgery of the upper extremities Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hitham M Elsayed, MD
Phone
00201029106541
Email
haytham_elsayed@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed A Mahroos, MD
Phone
00201091328413
Email
mahroos_mohammed@yahoo.com
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
ZIP/Postal Code
82516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed A Mahroos, MD
Phone
00201029106541
Email
mahroos_mohammed@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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