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

NCT06309381 | Completed

• 1 other identifier: CEIm2.23
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Doctor Peset: lead

Study Sites (1)

Av. de Gaspar Aguilar, 90

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Javier Barrio, MD, PhD

  Hospital Universitario Doctor Peset

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 13, 2024
• Study Start: February 8, 2023
• Primary Completion: May 27, 2024
• Study Completion: December 2, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)