Awake Local Anesthesia Infiltration Compared to Regional Nerve Block for Hand Surgeries

NCT ID: NCT05767944

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2022-10-20

Brief Summary

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The study trying to fined out the best anaesthesia technique for hand flexor procedures which provide efficient anaesthesia while providing adequate surgical field exposure \& less blood loss

Detailed Description

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The current study compared patients scheduled for hand surgical procedures using wide awake local anaesthetic infiltration to those receiving supra-clavicular brachial plexus block. the comparison including adequacy of pain control, blood loss, patient satisfaction, time \& skills needed to provide aesthetic technique.

Conditions

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Anaesthesia Conduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients were allocated to one of two groups. one received WALANT (with no tourniqut) \& the other (control) group received supra-clavicular block (with tourniquet). Groups were compared for anaesthesia efficiency
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
For those assessing \& providing postoperative analgesia (secondary outcome)they are blind to the used anaesthetic technique .

Study Groups

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Wide Awake Local Anesthesia (WALANT)

Study arm: (WALANT) patient received local anaesthesia (25ml of 2%lidocaine with 0.5 ml of adrenaline (1mg/mL) and 5 ml of 8.4% of sodium bicarbonate. the final 50 ml mixture contained 10 mg/ml Lidocaine and adrenaline 1:100,000 concentration) infiltration along rays at site of surgery (15 ml or more per ray (150 mg lidocaine) by 27G needle, 10 ml (or more) in the palm, then 2 ml in the proximal and middle phalanges and 1 ml in the distal phalanx (if required )) for hand flexor tendons repair.

Group Type EXPERIMENTAL

local anaesthesia infiltration

Intervention Type OTHER

Infiltration of 150 mg of lidocaine solution per ray at site of surgical incision for flexor tendon repair in the palm, the 2 proximal \& distal phalanges

Supra Clavicular- Brachial Plexus Block (SC-BPB)

Control arm:(SC-BPB): ultrasound-guided injection of local aesthetics (15 mL of 2% lidocaine and 15 mL of 0.5% bupivacaine were injected incrementally over 3-5 min) at supra-clavicular level where brachial plexus trunks are located this will provide anesthesia for the whole upper limb distal to shoulder joint.

Group Type ACTIVE_COMPARATOR

brachial plexus block

Intervention Type OTHER

ultrasound-guided infiltration of local aesthetics around brachial plexus trunks \& divisions

Interventions

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local anaesthesia infiltration

Infiltration of 150 mg of lidocaine solution per ray at site of surgical incision for flexor tendon repair in the palm, the 2 proximal \& distal phalanges

Intervention Type OTHER

brachial plexus block

ultrasound-guided infiltration of local aesthetics around brachial plexus trunks \& divisions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants were included if they were to be scheduled for Flexor tendon repair (Interventions involving flexor tendons of the wrist (Flexor Carpi Ulnaris (FCU), Flexor Carpi Radialis (FCR), and/or Palmaris Longus PL), fingers (flexor digitorum Profundus FDP and/or Flexor Digitorum Superficialis FDS) and thumb (Flexor Pollicis Longus FPL)), aged 18 years or over \& of ASA physical status I or II.

Exclusion Criteria

* Participants were excluded if they were (American society of Anaesthesia) ASA physical status III or IV, refusal of anaesthetic procedure or refuse to participation in the study, documented hypersensitivity to lidocaine, compromised peripheral circulation (Patients with previous vascular injury, vasculitis, Buerger's disease, and scleroderma), evidence of infection at injection site, patients with ischemic heart disease or psychiatric illness and patients with concomitant injuries that needed further operative procedure under general anesthesia or spinal anesthesia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salwa O. Mohammed, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assistant professor, Ain Shams University, Faculty of Medicine

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS 242/2022

Identifier Type: -

Identifier Source: org_study_id

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