NCT05635383

Brief Summary

In recent years, the use of regional anesthesia techniques as part of multimodal analgesia strategies to maximize pain control in patients has reduced opioid requirements and promoted early mobility and rehabilitation in the perioperative period. Regional anesthesia has benefits, mainly peripheral nerve blocks (PNB), muscle relaxation, and postoperative analgesia, thus allowing for control of postoperative pain and early discharge from the hospital. In addition, using PNB techniques provides: Hemodynamic stability. Reduced need for a post-anesthetic care unit (PACU). Reduced unplanned hospitalization for pain control. Less airway management. Reduced incidence of opioid-related adverse events. Greater patient satisfaction The main feature of rebound pain is that it is severe pain, within 8-24 hours after PNB. It usually remains severe for 2-6 hours, but the subsequent pain trajectory is consistent with the recovery process expected at surgical intervention. Therefore, rebound pain is temporary and different from persistent post-surgical pain (PPSP). Rebound pain often occurs at night. However, this is probably related to the 8 to 12-hour duration of most single-injection PNBs and the completion of most elective surgeries during daylight hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2024

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

November 23, 2022

Last Update Submit

March 27, 2024

Conditions

Keywords

REBOUND PAINPERIPHERAL NERVE BLOCKSanalgesia

Outcome Measures

Primary Outcomes (1)

  • incidence of rebound pain

    Rebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked.

    perioperative period

Secondary Outcomes (1)

  • rebound pain risk factors

    perioperative period

Interventions

Observation of rebound pain after peripheral nerve block application

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged \>18 years who underwent orthopedic surgery with the peripheral nerve block will be included in the study.

You may qualify if:

  • Patients aged \>18 years who underwent orthopedic surgery with the peripheral nerve block

You may not qualify if:

  • Patients who did not want to participate in the study
  • dementia
  • severe psychiatric or cognitive dysfunction
  • coagulopathy
  • neuropathic disorder
  • local anesthetic allergy
  • serious heart-lung disease
  • chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Medical Science, Yıldırım Beyazıt Training and Research Hospital

Ankara, 06000, Turkey (Türkiye)

Location

Diskapi Yildirim Beyazit Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011.

    PMID: 17543812BACKGROUND
  • Gramke HF, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Sommer M, Marcus MA. Predictive factors of postoperative pain after day-case surgery. Clin J Pain. 2009 Jul-Aug;25(6):455-60. doi: 10.1097/AJP.0b013e31819a6e34.

    PMID: 19542791BACKGROUND
  • Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.

MeSH Terms

Conditions

PainBites and StingsAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 2, 2022

Study Start

August 1, 2022

Primary Completion

January 1, 2024

Study Completion

March 12, 2024

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations