NCT03599024

Brief Summary

Total hip replacement (THR) is frequently followed by high pain experience. Epidural analgesia is a mainstay in postoperative treatment in patients after THR. The investigators found that patient-controlled epidural analgesia (PCEA) decreases total analgesics consumption compared to conventional method of analgesia based on physician's prescription while maintaining similar pain relief and safety profile. Therefore, PCEA should be considered the first choice method of analgesia in patients undergoing THR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

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

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

May 16, 2018

Last Update Submit

July 16, 2018

Conditions

Hip Joint Disorders

Keywords

patient-controlled analgesiaepidural analgesiaanalgesicsdrug consumptiontotal hip replacementpain relief

Outcome Measures

Primary Outcomes (1)

  • Difference in consumption of analgesics

    The primary goal of this prospective, randomized study was to compare the effects of two different sufentanil-based methods of analgesia; patient controlled (PCEA) and conventional non-PCEA) where drug is delivered according to the physician's prescription. The main goal was to determine any difference in total consumption of analgesics.

    18 months

Secondary Outcomes (6)

  • Patient satisfaction - 24 hours after surgery

    24 hours

  • Degree of pain intensity - 24 hours after surgery

    24 hours

  • Safety of analgesics administration - hypotension

    24 hours

  • Safety of analgesics administration - bradypnea

    24 hours

  • Safety of analgesics administration - heart rate abnormalities

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

PCEA Group

EXPERIMENTAL

The patients randomized into this arm were able to control the administration of analgesics, according to their subjective condition.

Procedure: PCEAProcedure: Total hip replacement

Non-PCEA Group

ACTIVE COMPARATOR

The patients randomized into this arm were receiving analgesics according to the physician's prescription.

Procedure: Non-PCEAProcedure: Total hip replacement

Interventions

PCEAPROCEDURE

The patients were able to control the administration of analgesics by themselves.

Also known as: Patient-controlled epidural analgesia (PCEA)
PCEA Group
Non-PCEAPROCEDURE

The patients were receiving analgesics according to the physician's prescription.

Also known as: Non-patient controlled epidural analgesia (Non-PCEA)
Non-PCEA Group
Total hip replacementPROCEDURE

All patients enrolled in the study were indicated for total hip replacement surgery.

Non-PCEA GroupPCEA Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • ASA I-III on pre-anesthesia evaluation
  • ICU admission after total hip replacement surgery
  • Glasgow Coma Scale (GCS) 13 or more
  • Spontaneous breathing at a rate of 12-24 breaths/min
  • SpO2 ≥ 90%
  • Modified Bromage Score 0 or 1
  • Visual analog scale (VAS) ≥ 4
  • Signed Informed Consent Form for participation

You may not qualify if:

  • History of long-term opioid therapy (the use of an opioid analgesic at doses higher than codeine 120 mg/day, hydrocodone 40 mg/day, tramadol 200 mg/day or oxycodone 40 mg/day 0-4 days before surgery)
  • Indications for revision surgery during immediate postoperative care
  • Acute skin disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Related Publications (4)

  • Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg. 2002 Mar-Apr;10(2):117-29. doi: 10.5435/00124635-200203000-00007.

    PMID: 11929206BACKGROUND

  • Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.

    PMID: 16135349BACKGROUND

  • Hartrick CT, Bourne MH, Gargiulo K, Damaraju CV, Vallow S, Hewitt DJ. Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: a comparative study with morphine intravenous patient-controlled analgesia. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):546-54. doi: 10.1016/j.rapm.2006.08.011.

    PMID: 17138198BACKGROUND

  • Bertini L, Mancini S, Di Benedetto P, Ciaschi A, Martini O, Nava S, Tagariello V. Postoperative analgesia by combined continuous infusion and patient-controlled epidural analgesia (PCEA) following hip replacement: ropivacaine versus bupivacaine. Acta Anaesthesiol Scand. 2001 Jul;45(6):782-5. doi: 10.1034/j.1399-6576.2001.045006782.x.

    PMID: 11421841BACKGROUND

Related Links

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Renáta Zoubková, PhDr.

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Neither the investigators nor the patients were blinded in the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients were randomized into two groups with two distinct interventions - patient-controlled analgesia vs. conventional analgesia prescribed by the attending physician.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

July 26, 2018

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 31, 2016

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

The investigators do not plan to share the individual participant data with other researchers.

Locations

CZ(1)