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Completed

NCT Number: NCT05767944

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

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

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Key information

Conditions

Anaesthesia Conduction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

brachial plexus block

Other

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

Primary outcomes

  1. Intra-operative pain score

    Time frame: duration of operation

    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.

Secondary outcomes

  1. anaesthesia induction time

    Time frame: duration of operation

    the time taken to provide anesthesia

  2. Blood loss

    Time frame: duration of operation

    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.

  3. intra-operative preserved motor power intraoperative

    Time frame: duration of operation

    surgeon test the motor power after repair of the affected tendon

  4. operative time

    Time frame: duration of operation

    time from skin incision till last suture applied for wound closure

  5. patient satisfaction

    Time frame: 12 hours post operative

    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 "

  6. postoperative pain scores

    Time frame: 12 hours postoperatively

    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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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