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

NCT05767944 | Completed

• 1 other identifier: MS 242/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anaesthesia Conduction

Keywords

WALANT (Wide-Awake Local Anesthesia No Tourniquet ); Regional Anesthesia; Hand flexor Tendon Repair; Supra-clavicular brachial plexus block; Hand surgery

Outcome Measures

Primary Outcomes (1)

• Intra-operative pain score

  pain assessment during operation at the following moments: before the injection, during injections , during the incision , during gentle manipulation , during aggressive manipulation and during wound closure.

  duration of operation

Secondary Outcomes (6)

• anaesthesia induction time

  duration of operation

• Blood loss

  duration of operation

• intra-operative preserved motor power intraoperative

  duration of operation

• operative time

  duration of operation

• patient satisfaction

  12 hours post operative

Study Arms (2)

Wide Awake Local Anesthesia (WALANT)

EXPERIMENTAL

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.

Other: local anaesthesia infiltration

Supra Clavicular- Brachial Plexus Block (SC-BPB)

ACTIVE COMPARATOR

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.

Other: brachial plexus block

Interventions

local anaesthesia infiltration 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

Wide Awake Local Anesthesia (WALANT)

brachial plexus block OTHER

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

Supra Clavicular- Brachial Plexus Block (SC-BPB)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Brachial Plexus Block

Intervention Hierarchy (Ancestors)

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

Study Officials

• Salwa O. Mohammed, M.D.

  Assistant professor, Ain Shams University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For those assessing \& providing postoperative analgesia (secondary outcome)they are blind to the used anaesthetic technique .
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 14, 2023
• Study Start: March 29, 2022
• Primary Completion: September 15, 2022
• Study Completion: October 20, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)