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

Wide-Awake Local Anesthesia No Tourniquet (WALANT) Versus Regional Anesthesia With Tourniquet for Hand Flexor Tendon Repair Surgeries in Adults

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

Study Overview

• Status: Completed
• Conditions: Anaesthesia Conduction
• Intervention / Treatment: Other: local anaesthesia infiltration; Other: brachial plexus block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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
Active Comparator: 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.	Other: brachial plexus block; ultrasound-guided infiltration of local aesthetics around brachial plexus trunks & divisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
anaesthesia induction time	the time taken to provide anesthesia	duration of operation
Blood loss	calculated based upon the number and degree of soaking of swabs used in the operation and the amount in a suction container in the operation room.	duration of operation
intra-operative preserved motor power intraoperative	surgeon test the motor power after repair of the affected tendon	duration of operation
operative time	time from skin incision till last suture applied for wound closure	duration of operation
patient satisfaction	was measured and recorded using five-point Likert scale[25] (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied) with checklist and a closed-ended question "If you were to undergo this surgery again, would you choose the same type of anaesthesia? YES or NO "	12 hours post operative
postoperative pain scores	numeric pain rating scale (NRS)A respondent selected a whole number (0- 10 integers) that best reflects the intensity of his pain, 0-10 was recorded by a blinded investigator at 2, 4, 6, 8, 10, 12 hours postoperatively, time of 1st call for postoperative analgesia was recorded, patients received 25 mg pethidine IV if the NRS pain exceeds 3, the dose was repeated on patient's demand with 2 hours minimal time interval between doses, total analgesic dose required in the 1st twelve hours postoperatively	12 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Salwa O. Mohammed, M.D., Assistant professor, Ain Shams University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Hand surgery; WALANT (Wide-Awake Local Anesthesia No Tourniquet ); Hand flexor Tendon Repair; Supra-clavicular brachial plexus block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: MS 242/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No