Anaesthesia ConductionNCT05767944
Awake Local Anesthesia Infiltration Compared to Regional Nerve Block for Hand Surgeries
A study testing local anaesthesia infiltration and brachial plexus block in people with Anaesthesia Conduction, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaesthesia Conduction
- What is being tested?
- local anaesthesia infiltration and brachial plexus block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Mar 2022to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Anaesthesia Conduction
- Being tested
- local anaesthesia infiltration, brachial plexus block
- Keywords
- WALANT (Wide-Awake Local Anesthesia No Tourniquet ), Regional Anesthesia, Hand flexor Tendon Repair, Supra-clavicular brachial plexus block, Hand surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anaesthesia infiltrationOther
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 blockOther
ultrasound-guided infiltration of local aesthetics around brachial plexus trunks \& divisions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: duration of operation
Secondary outcomes (6)
anaesthesia induction time
the time taken to provide anesthesia
Measured: 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.
Measured: duration of operation
intra-operative preserved motor power intraoperative
surgeon test the motor power after repair of the affected tendon
Measured: duration of operation
operative time
time from skin incision till last suture applied for wound closure
Measured: 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 "
Measured: 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
Measured: 12 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start29 Mar 2022
- Primary completion15 Sep 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaesthesia ConductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 efficiency
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salwa O. Mohammed, M.D., Principal investigator, Assistant professor, Ain Shams University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767944
- Sponsor's protocol ID
- MS 242/2022
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide-Awake Local Anesthesia No Tourniquet (WALANT) Versus Regional Anesthesia With Tourniquet for Hand Flexor Tendon Repair Surgeries in Adults
- ClinicalTrials.gov ID
- NCT05767944
- Acronym / sponsor ID
- MS 242/2022
- Conditions
- Anaesthesia Conduction
- Keywords
- WALANT (Wide-Awake Local Anesthesia No Tourniquet ), Regional Anesthesia, Hand flexor Tendon Repair, Supra-clavicular brachial plexus block, Hand surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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 efficiency
| Arm | Type | Receives |
|---|---|---|
| Wide Awake Local Anesthesia (WALANT) | Experimental | Other: local anaesthesia infiltrationStudy 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. |
| Supra Clavicular- Brachial Plexus Block (SC-BPB) | Active comparator | Other: brachial plexus blockControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anaesthesia infiltrationInfiltration 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 | Other | Wide Awake Local Anesthesia (WALANT) |
| brachial plexus blockultrasound-guided infiltration of local aesthetics around brachial plexus trunks \& divisions | Other | Supra Clavicular- Brachial Plexus Block (SC-BPB) |
Primary outcome
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.
6 secondary outcomes
anaesthesia induction time
Time frame: duration of operation
Blood loss
Time frame: duration of operation
intra-operative preserved motor power intraoperative
Time frame: duration of operation
operative time
Time frame: duration of operation
patient satisfaction
Time frame: 12 hours post operative
postoperative pain scores
Time frame: 12 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Anaesthesia Conduction
Not yet recruitingObservational study
Sustainable Anaesthesia Practices in EUROPE - a Prospective International Cohort Study
Anaesthesia Conduction, Paediatric and Adult Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salwa O. Mohammed, M.D. principal investigator
Assistant professor, Ain Shams University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anaesthesia infiltration and brachial plexus block in people with Anaesthesia Conduction, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative pain score (time frame: duration of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 31 Oct 2026.