Onset and duration of nerve block of the forearm in which 2 techniques will be compared; nerve block by injection at one site compared to injections at two site in the forearm; a blinded randomized controlled study.

Onset and duration of Forearm nerve blockade performed with a single distal injection versus sequential injections at distal and proximal locations alongside the nerves: a blinded randomized controlled trial. - 2-HIT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003694-34-BE

Enrollment

Registered

2017-10-02

Start date

2017-10-25

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren contrature and Carpal Tunnel syndrome MedDRA version: 20.0 Level: PT Classification code 10013873 Term: Dupuytren's contracture operation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10007697 Term: Carpal tunnel syndrome System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Lidocaine 1% Product Name: Linisol Pharmaceutical Form: Injection Trade Name: Bupivacaine 0.5% Product Name: Marcaine Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - adult patients between 18 and 80 years - scheduled to undergo daycare surgery for carpal tunnel syndrome or Dupuytren's contracture release under peripheral nerve blocks - ASA I, II or III - Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick and light touch - Scheduled to undergo primary hand surgery - Able to understand the Dutch language, purpose and risks of the study - Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule and complete all study assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: ? Currently pregnant or, nursing patients ? History of hypersensitivity to local anesthetics ? Contraindication to bupivacaine, paracetamol, ketorolac, oxycodone or morphine ? Medical condition that will make it difficult to assess sensory distributions of peripheral nerves or to communicate with staff ? Suspected or known recent history (44 kg/m2 ? Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments ? Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity ? Any chronic condition or disease that would compromise neurological or vascular assessments ? Presence of preexisting coagulation disorders ? Baseline neurological deficits

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to compare the onset and duration of sensory-motorblockade in subjects receiving local anesthetic injection in the distal forearm alone or separate injections in the distal and proximal forearm for hand surgery;Secondary Objective: The secondary objectives are to compare postoperative pain scores, opioids intake, satisfaction with analgesia and side effects or complications. Procedural time and intraoperative discomfort caused by the tourniquet will also be compared.;Primary end point(s): The primary endpoint is area under the curve (AUC) of the sensory-motor block scores through 7 days. ;Timepoint(s) of evaluation of this end point: 5-minute intervals beginning at the placement of first block up to 30 minutes, then every 15 minutes until ORentrance. Sensory-motor block will be tested every 15 minutes after surgery until PACU discharge. Patients will be contacted after discharge by phone twice a day for the first 7 days after surgery and again 30 days after surgery	—

Measure

Time frame

Main Objective: The primary objective of this study is to compare the onset and duration of sensory-motorblockade in subjects receiving local anesthetic injection in the distal forearm alone or separate injections in the distal and proximal forearm for hand surgery;Secondary Objective: The secondary objectives are to compare postoperative pain scores, opioids intake, satisfaction with analgesia and side effects or complications. Procedural time and intraoperative discomfort caused by the tourniquet will also be compared.;Primary end point(s): The primary endpoint is area under the curve (AUC) of the sensory-motor block scores through 7 days. ;Timepoint(s) of evaluation of this end point: 5-minute intervals beginning at the placement of first block up to 30 minutes, then every 15 minutes until ORentrance. Sensory-motor block will be tested every 15 minutes after surgery until PACU discharge. Patients will be contacted after discharge by phone twice a day for the first 7 days after surgery and again 30 days after surgery

—

Secondary

Measure	Time frame
Secondary end point(s): ? Time to first pain medication use ? NRS pain intensity score through 7 days and day 30 ? Amount of opioid pain medications taken ? Subject satisfaction with overall analgesia at postoperative days 1 through 7 and day 30 ? Number of unscheduled phone calls or hospital visits related to pain after discharge ;Timepoint(s) of evaluation of this end point: ? NRS at baseline (prior to the nerve block): 1 and 2 hours, at hospital discharge, and twice a day in the first 7 days after surgery ? Date, time and amount of all pain medication taken in the first 7 days after surgery ? Subject satisfaction with overall analgesia twice a day in the first 7 days after surgery	—

Measure

Time frame

Secondary end point(s): ? Time to first pain medication use ? NRS pain intensity score through 7 days and day 30 ? Amount of opioid pain medications taken ? Subject satisfaction with overall analgesia at postoperative days 1 through 7 and day 30 ? Number of unscheduled phone calls or hospital visits related to pain after discharge ;Timepoint(s) of evaluation of this end point: ? NRS at baseline (prior to the nerve block): 1 and 2 hours, at hospital discharge, and twice a day in the first 7 days after surgery ? Date, time and amount of all pain medication taken in the first 7 days after surgery ? Subject satisfaction with overall analgesia twice a day in the first 7 days after surgery

—

Countries

Belgium

Contacts

Public ContactCatherine Vandepitte

Ziekenhuis Oost-Limburg

catherine@nysora.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026