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

NCT ID: NCT05083663

Last Updated: 2021-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2021-12-31

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:

1. Onset of complete sensory block (time from injection to complete sensory block to pin prick).

2. Onset of complete motor block (time from injection to complete motor block).

Secondary measurements:

1. Duration of analgesia defined as time from injection to first analgesia request.

2. Duration of sensory block (time between injection and complete recovery of sensation)

3. Duration of motor block (time between injection and complete recovery of motor power)

4. 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.

Conditions

Postoperative Pain

Keywords

hyaluronidase; supraclavicular block; buivacaine; ultrasound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Group I

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

Group Type: EXPERIMENTAL

Hyaluronidase

Intervention Type: DRUG

using hyaluronidase as an additive to bupivacaine

Group II

received bupivacaine 0.375% 15 mL + normal saline5 ml.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyaluronidase

using hyaluronidase as an additive to bupivacaine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Hitham Mohammed Aly Elsayed

lecturer of anesthesia and surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hitham M Elsayed, MD

Role: CONTACT

Phone: 00201029106541

Email: haytham_elsayed@med.sohag.edu.eg

Mohammed A Mahroos, MD

Role: CONTACT

Phone: 00201091328413

Email: mahroos_mohammed@yahoo.com

Facility Contacts

Mohammed A Mahroos, MD

Role: primary

Other Identifiers

Soh-Med-21.09.04

Identifier Type: -

Identifier Source: org_study_id