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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Outpatient Surgery; Foot Surgery; Rebound Pain; Sciatic Nerve Block

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Javier Barrio, MD, PhD; Phone Number: 0034646819882; Email: jbarrio.ma@gmail.com

Study Locations

• Spain
  • Valencia, Spain, 46017
    • Recruiting
    • Av. de Gaspar Aguilar, 90
    • Contact: Javier Barrio, MD, PhD; Phone Number: 0034646819882; Email: jbarrio.ma@gmail.com
    • Principal Investigator: Javier Barrio, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Hospital Universitario Doctor Peset
• Investigators: Principal Investigator: Javier Barrio, MD, PhD, Hospital Universitario Doctor Peset

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Sciatic Nerve Block; Acute Pain; Pain, Postoperative; Rebound pain; Foot surgery; Orthopedic Procedures; Outpatient Surgery
• Other Study ID Numbers: CEIm2.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No