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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05767944
Collaborator
(none)
50
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2
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7.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: local anaesthesia infiltration
  • Other: brachial plexus block
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 efficiencypatients 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
Masking:
Single (Outcomes Assessor)
Masking Description:
For those assessing & providing postoperative analgesia (secondary outcome)they are blind to the used anaesthetic technique .
Primary Purpose:
Other
Official Title:
Wide-Awake Local Anesthesia No Tourniquet (WALANT) Versus Regional Anesthesia With Tourniquet for Hand Flexor Tendon Repair Surgeries in Adults
Actual Study Start Date :
Mar 29, 2022
Actual Primary Completion Date :
Sep 15, 2022
Actual Study Completion Date :
Oct 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Wide Awake Local Anesthesia (WALANT)

Study arm: (WALANT) patient received local anaesthesia infiltration at site of surgery 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 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

Outcome Measures

Primary Outcome Measures

  1. Intra-operative pain score [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 Outcome Measures

  1. anaesthesia induction time [duration of operation]

    the time taken to provide anesthesia

  2. Blood loss [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 [duration of operation]

    surgeon test the motor power after repair of the affected tendon

  4. operative time [duration of operation]

    time from skin incision till last suture applied for wound closure

  5. patient satisfaction [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University Hospitals Cairo Egypt 11591

Sponsors and Collaborators

  • Ain Shams University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT05767944
Other Study ID Numbers:
  • MS 242/2022
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ain Shams University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023