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

Not Applicable

Completed

• Conditions: Anaesthesia Conduction
• Interventions: Other: brachial plexus block; Other: local anaesthesia infiltration

• Registration Number: NCT05767944
• Lead Sponsor: Ain Shams University

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

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 Timeline

• Study Start: 2022-03-29
• Primary Completion: 2022-09-15
• Study Completion: 2022-10-20
• Study First Submitted: 2023-01-26
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-12
• Study First Posted: 2023-03-14
• Last Update Submitted: 2023-06-17
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supra Clavicular- Brachial Plexus Block (SC-BPB)	brachial plexus block	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.
Wide Awake Local Anesthesia (WALANT)	local anaesthesia infiltration	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
anaesthesia induction time	duration of operation	the time taken to provide anesthesia
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
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 "
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.
intra-operative preserved motor power intraoperative	duration of operation	surgeon test the motor power after repair of the affected tendon
operative time	duration of operation	time from skin incision till last suture applied for wound closure

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt