Comparison of the Onset Times and Durations of Actions of Different Local Anesthetic Mixture Solutions [CODLAM]

NCT03454789 | Completed

• 1 other identifier: 6940
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective To investigate the onset times and duration of local anesthetic mixture solutions used for axillary-supraclavicular brachial plexus blocks and to compare the quality of anesthesia in patients with trauma of the upper limb. Design Randomized-prospective, observational study. Setting Perioperative, Trauma Clinic, University of Pecs, Hungary. Participants 85 consecutive, unpremedicated ASA physical status I-III patients, between the ages of 19 and 83, scheduled for trauma surgery of the hand and forearm. Interventions Patients assigned to four groups for standardized ultrasound guided axillary-supraclavicular block with lidocaine 1% and bupivacaine 0,5% 1:1 mixture (Group LB, n = 17) or bupivacaine 0.33% (Group BS, n = 14) or lidocaine 0,66% (Group LS, n = 14) or bupivacaine 0.5% and lidocaine 1% 2:1 mixture (Group BL, n = 40). Total target volume of 0.4 ml/kg was administered to both groups. Measurements Data were collected on patient demographics, the onset times and the duration of actions of local anesthetic mixtures were measured, the tourniquet discomfort, vital parameters, pre and postoperative verbal numeric rating scale of pain intensity, anxiolytic/analgesic consumption and the complications were recorded. The quality of anesthesia was assessed by a sensory-motor-coping-pain scale (0-16).

Conditions

Injury Arm

Keywords

brachial plexus block; local anesthetic mixture solution; axillary-supraclavicular approach; outcome quality; lidocaine, bupivacaine; onset time; duration action local anesthetic; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• onset time

  Complete sensory block was defined by loss of sensation of filament prick and touch on all four nerve distribution. Complete motor block was defined by the loss of thumb abduction, thumb adduction, thumb opposition, and flexion at elbow.

  0-30 minutes

Secondary Outcomes (3)

• duration of action

  1-22 hours

• The outcome quality of BPB.

  24-48 hours

• Success rate of BPB.

  3-14 days

Study Arms (4)

LB Group

ACTIVE COMPARATOR

Ultrasound-guided brachial plexus block for LB Group (15 ml lidocaine 1% + 15 ml bupivacaine 0.5%)

Drug: brachial plexus block for LB Group

BS Group

ACTIVE COMPARATOR

Ultrasound-guided brachial plexus block for BS Group (20 ml bupivacaine 0.5% + 10 ml normal saline)

Drug: brachial plexus block for BS Group

LS Group

ACTIVE COMPARATOR

Ultrasound-guided brachial plexus block for LS Group (20 ml lidocaine 1% + 10 ml normal saline)

Drug: brachial plexus block for LS Group

BL Group

ACTIVE COMPARATOR

and Ultrasound-guided brachial plexus block for BL Group (20 ml bupivacaine 0.5% + 10 ml lidocaine 1%)

Drug: brachial plexus block for BL Group

Interventions

brachial plexus block for LB Group DRUG

Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW

Also known as: Lidocain-Egis 1% Bucain Actavis 5 mg/ml,1:1

LB Group

brachial plexus block for BS Group DRUG

Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW

Also known as: Bucain Actavis 5 mg /ml

BS Group

brachial plexus block for LS Group DRUG

Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW

Also known as: Lidocain Egis 1%

LS Group

brachial plexus block for BL Group DRUG

Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW

Also known as: Bucain Actavis 5 mg/ml, Lidocain-Egis 1% 2:1

BL Group

Eligibility Criteria

• Age: 19 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective or emergency trauma surgery of hand or forearm
• consented to ultrasound-guided BPB

You may not qualify if:

• continuous peripheral nerve catheter technique or bilateral block was planned
• the patient refused to participate
• psycho-mental conditions interfering with consent or assessment
• pre-existing chronic pain condition or daily analgesic or sedative consumption
• sedative or analgesic premedication
• pre-existing neurological disorders affecting the brachial plexus
• obstructive sleep apnea
• contraindications to PNB including local skin infections or allergy to LA agents.

Sponsors & Collaborators

• University of Pecs: lead
• Medical University of Pecs: collaborator

MeSH Terms

Conditions

Arm Injuries

Interventions

Brachial Plexus Block

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Lajos Bogar, Prof

  Department of Anesth.and Int Care,University of Pecs, Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, the operating team, nurses, and observers involved in the quality assessment of blocks and the follow-up data collection were unaware of group allocation. The research coordinator after the BPB was not present in the operating theatre at the time of tourniquet inflation and the beginning of the surgery. The intra- and postoperative parameters, drug consumptions and VNR values were collected and matched retrospectively, the list of cases was provided in the form of a spreadsheet program by an observer-blinded assistant and was statistically evaluated by an independent analyst.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: LB= 15 ml lidocaine 1% + 15 ml bupivacaine 0.5%; BS= 20 ml bupivacaine 0.5% + 10 ml normal saline; LS=20 ml lidocaine 1% + 10 ml normal saline; and BL=20 ml bupivacaine 0.5% + 10 ml lidocaine 1%.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 6, 2018
• Study Start: January 17, 2017
• Primary Completion: August 15, 2017
• Study Completion: November 30, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03