Skip to content

Ultrasound Guided Distal Peripheral Nerve Blocks and Postoperative Pain.

Effectiveness of Distal Peripheral Nerve Blocks on Postoperative Pain Management After Ambulatory Thumb Resection Arthroplasty.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01597479
Enrollment
52
Registered
2012-05-14
Start date
2012-02-29
Completion date
2014-04-30
Last updated
2016-03-21

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

Conditions

Postoperative Pain

Keywords

Ultrasound guided distal peripheral nerve blocks

Brief summary

The aim of this clinical trial is to determinate if distal ultrasound guided peripheral nerve blocks on target nerves (radial and median nerve blocks at the elbow), using low volume and low concentration of long acting local anesthetic provide better postoperative pain control compare with systemic analgesia alone after thumb resection arthroplasty (TRA) due to a prolonged selective sensitive block on the tissue trauma.

Detailed description

We designed a prospective randomized controlled trial, with nursing blinded evaluation. We enrolled 52 patients scheduled for elective ambulatory TRA. 2 patients were excluded after randomization. Patients were randomized into two groups: A. Group A= no distal peripheral nerve blocks (no dPNBs group; n = 24 ): We performed usual anesthetic technique for surgery: an AXILLARY BRAQUIAL PLEXUS BLOCK using SHORT ACTING local anesthetic (mepivacaine 1%). Patients allocated in this group didn't received any additional intervention in the postoperative period. B. Group B (dPNBs group; n = 26): We performed the same anesthetic technique for surgery (AXILLARY BLOCK with 1% of mepivacaine) with an additional intervention. Patients allocated in this group received postoperatively dPNBs on target nerves. Based on surgical approached and technique we evaluated that radial and median nerves were responsible for the innervation of the surgical area, and therefore responsible for the postoperative pain. We performed dPNBs ON RADIAL AND MEDIAN NERVES (TARGET NERVES) WITH LONG ACTING AND LOW CONCENTRATION LOCAL ANESTHETIC (0,125% levobupivacaine 5ml/nerve). All blocks were performed under ultrasound guidance. Analgesic regime prescribed at discharge was the same in both groups: dexketoprofen with tramadol for rescue analgesia. The primary outcome was to evaluate the proportion of patients experienced moderate to severe pain during first and second day postoperatively, mesured using a numerical visual scale (NVS) of 0 to 10 (0= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3), moderate pain (NVS 7-10) and severe pain (NVS 7-10). We considered dPNBs effective when patients experienced mild pain (NVS 0-3) for at least 6 hours after dPNBs puncture. Secondary outcomes included: 1. Maximum pain intensity during first and second day postoperatively. 2. Duration of dPNBs, defined as the interval between dPNBs performance and the occurrence of first pain. 3. Time to discharge, defined as the interval since patient arrived at postoperative care unit (PACU) until discharge home. 4. Presence of distal hand motor block after dPNBs puncture. 5. Needed for rescue analgesia and total consumption of tramadol during first and second day postoperatively 6. Incidence of postoperative nausea and vomiting during 1st and 2nd day postoperatively 7. Needed for rescue antiemetic therapy, total consumption of ondansetron and effectiveness of treatment during 1st and 2nd day postoperatively. Patients were contacted by phone first and second day postoperatively from a blinded PACU nursing staff (all outcome data were collected by PACU nursing staff blinded to group allocation).

Interventions

DRUGLevobupivacaine

In dPNBs group, we performed ultrasound guided dPNBs on radial and median nerves using low concentration and low volume of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve). Using low concentrations of levobupivacaine on target nerves could achieve a prolonged sensitive block in the surgical area without motor block of the hand.

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age more than 18 years. * Ambulatory TRA. * Free acceptance to participate in the study, with informed consent signed by patient, guardian or family member.

Exclusion criteria

* Age less than 18 years * Pregnancy. * Inability to provide informed consent. * Allergy to amide local anesthetics/NSAIDs * Preexisting chronic pain treated with opioids. * Neuropathy involving the extremity undergoing surgery or neurological-cognitive deficits that may interfere in the assessement. * Contraindications to dPNBs

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative DayUp to 48 hoursPain scores assessed using pain numerical visual scale (NVS) of 0-10 (o= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3); moderate pain (NVS 4-6) and severe pain (NVS 7-10).The analysis of this variable at the end of the study will confirm or not the effectiveness of dPNBs for management of postoperative pain after TRA.

Secondary

MeasureTime frameDescription
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronUp to 48 hoursNumber of participants with Maximum pain intensity NVS \> 3; Rescue analgesia; Nausea and Vomiting incidence; use of ondansetron for NVPO; Ondansetron being effective (number of participants for whom ondansetron was effective to stop NVPO).

Countries

Spain

Participant flow

Recruitment details

Between february 2010 and april 2014, we enrolled 52 patients scheduled for elective ambulatory TRA under rutine axillary braquial plexus block.

Participants by arm

ArmCount
dPNBs Group
dPNBs on radial and median nerves at the elbow in postoperative period, before discharge
24
Non dPNBs Group
Non intervention in postoperative period
26
Total50

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up10
Overall StudyProtocol Violation10

Baseline characteristics

CharacteristicdPNBs GroupNon dPNBs GroupTotal
Age, Continuous
years
67.4 years
STANDARD_DEVIATION 6.5
64.2 years
STANDARD_DEVIATION 7.5
65.7 years
STANDARD_DEVIATION 7.2
Region of Enrollment
Spain
24 participants26 participants50 participants
Sex: Female, Male
Female
21 Participants21 Participants42 Participants
Sex: Female, Male
Male
3 Participants5 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 24
serious
Total, serious adverse events
0 / 24

Outcome results

Primary

Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day

Pain scores assessed using pain numerical visual scale (NVS) of 0-10 (o= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3); moderate pain (NVS 4-6) and severe pain (NVS 7-10).The analysis of this variable at the end of the study will confirm or not the effectiveness of dPNBs for management of postoperative pain after TRA.

Time frame: Up to 48 hours

Population: Patients undergoing ambulatory thumb resection arthroplasty (TRA)

ArmMeasureGroupValue (NUMBER)
Distal Peripheral Nerve Blocks Group (dPNBs Group)Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative DayPain intensity NVS>3 on call 24h8.3 percentage of patients
Distal Peripheral Nerve Blocks Group (dPNBs Group)Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative DayPain intensity NVS>3 on call 48h4.2 percentage of patients
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative DayPain intensity NVS>3 on call 24h80.8 percentage of patients
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative DayPain intensity NVS>3 on call 48h42.3 percentage of patients
Secondary

Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron

Number of participants with Maximum pain intensity NVS \> 3; Rescue analgesia; Nausea and Vomiting incidence; use of ondansetron for NVPO; Ondansetron being effective (number of participants for whom ondansetron was effective to stop NVPO).

Time frame: Up to 48 hours

Population: Patients undergoing ambulatory thumb resection arthroplasty

ArmMeasureGroupValue (NUMBER)
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronRescue analgesia 24h (n)2 participants
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronNausea and vomiting 48h (n)0 participants
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronMaximum pain intensity 48h (NVS >3)5 participants
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronRescue Analgesia 48h (n)5 participants
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronUse of ondansetron 48h (n)0 participants
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronMaximum pain intensity 24h (NVS>3)8 participants
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronEffectiveness of ondansetron 24h1 participants
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronNausea and vomiting 24h (n)1 participants
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronEfectiveness of ondansetron 48h0 participants
Distal Peripheral Nerve Blocks Group (dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronUse of ondansetron 24h (n)1 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronEfectiveness of ondansetron 48h2 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronMaximum pain intensity 24h (NVS>3)24 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronMaximum pain intensity 48h (NVS >3)21 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronRescue analgesia 24h (n)17 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronRescue Analgesia 48h (n)17 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronNausea and vomiting 24h (n)10 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronNausea and vomiting 48h (n)5 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronUse of ondansetron 24h (n)5 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronUse of ondansetron 48h (n)5 participants
Non Distal Peripheral Nerve Blocks (Non dPNBs Group)Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of OndansetronEffectiveness of ondansetron 24h4 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026