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

Foot Surgery Clinical Trial

Official title:

Rebound Pain After Outpatient Orthopaedic Foot Surgery Under Popliteal Sciatic Nerve Block: Influence of Sensory Block Duration. An Observational Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06309381
• Other study ID #: CEIm2.23
• Status: Recruiting
• Start date: February 8, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Hospital Universitario Doctor Peset
• Contact: Javier Barrio, MD, PhD
• Phone: 0034646819882
• Email: jbarrio.ma[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Av. de Gaspar Aguilar, 90	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Doctor Peset

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 72 hours.
Primary	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.	Up to 72 hours.