CClinicalTrials.gg
CompletedNCT06309381Updated Dec 4, 2024

Influence of Sensory Block Duration on Rebound Pain After Outpatient Foot Surgery Under Popliteal Sciatic Nerve Block.

An observational study in Rebound Pain, Sciatic Nerve Block and Foot Surgery, sponsored by Hospital Universitario Doctor Peset. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Hospital Universitario Doctor Peset · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
107
Ages
18 Years and older
Sex
All
01

Study summary

Rebound pain after surgeries under peripheral nerve block is defined as the appearance of severe acute postoperative pain after regression of the sensory block. The incidence of this condition can reach up to 40-50% in patients undergoing ambulatory surgeries. Rebound pain represents a clinically significant issue that may outweigh the benefits of regional anaesthesia. This is particularly significant for painful outpatient surgeries, where inadequately managed pain can result in distress, potentially affecting patient satisfaction and recovery. It may also lead to unplanned utilization of healthcare resources or readmissions.

Orthopaedic foot surgery is a prevalent outpatient surgery, potentially painful, where rebound may be a difficult challenge. However, to date, prospective studies focusing specifically on rebound pain in outpatient foot surgery are limited. Identifying conditions associated with rebound pain or at-risk patients could facilitate the development of preventive and treatment strategies, thereby enhancing pain management or relief. Younger age, female sex and bone surgery are non-modifiable factors associated with severe rebound pain. Perioperative intravenous dexamethasone has been identified as a modifiable independent risk factor associated with a reduced incidence of rebound pain. Regarding anaesthetic factors, the duration of the peripheral block has been proposed as a potentially modifiable factor influencing rebound pain; however, current evidence does not support this hypothesis.

The goal of this prospective observational study is to evaluate the incidence of rebound pain specifically in outpatient orthopaedic foot surgery involving bone under popliteal sciatic nerve block and to assess the possible association between sensory block duration and the incidence of rebound pain.

02

Conditions studied

  • Rebound Pain
  • Sciatic Nerve Block
  • Foot Surgery
  • Outpatient Surgery

Keywords

  • Acute Pain
  • Pain, Postoperative
  • Rebound pain
  • Sciatic Nerve Block
  • Orthopedic Procedures
  • Foot surgery
  • Outpatient Surgery
03

In context

Lead sponsor

Hospital Universitario Doctor Peset is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (>18 years old), ASA physical status class 1 to 3, scheduled for elective outpatient orthopaedic foot surgery involving bone under popliteal sciatic nerve block.

Inclusion criteria

  • adult patients (>18 years old), ASA physical status 1 to 3, scheduled for elective outpatient orthopaedic foot surgery involving bone under popliteal sciatic nerve block.

Exclusion criteria

Exclusion Criteria:

  • age younger than 18 years, ASA physical status greater than 3, surgery not performed under popliteal sciatic nerve block or cases of failed sciatic nerve block, patients with type-1 diabetes or those under treatment for chronic pain.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
107 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of rebound pain.

    Rebound pain is defined as the appearance of severe acute postoperative pain (numerical rating scale (NRS) ≥7) after regression of the sensory block of the sciatic nerve block. The highest self-reported NRS pain score after the block wears off and NRS pain scores at 24 hours, 48 hours and 72 hours (if necessary) after the block will be recorded.

    Time frame: Up to 72 hours.

  2. Sensory block duration of the sciatic nerve block.

    Sensory block duration is defined as the time (hours) from block establishment to the appearance of pain at the surgical site.

    Time frame: Up to 72 hours.

07

Study locations

1 site
  • Av. de Gaspar Aguilar, 90
    Valencia, 46017, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06309381
Lead sponsor
Hospital Universitario Doctor Peset
Responsible party
Javier Barrio (MD, PhD, Hospital Universitario Doctor Peset) — Principal investigator
First posted
Mar 13, 2024
Start date
Feb 8, 2023
Primary completion
May 27, 2024
Completion
Dec 2, 2024
Last update
Dec 4, 2024

Study contacts

Javier Barrio, MD, PhD
principal investigator · Hospital Universitario Doctor Peset

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion