NCT06221319

Brief Summary

Total hip arthroplasty (THA) is a surgery that relieves hip joint pain and improves its functions and is widely performed in the elderly population. New analgesic methods need to be developed to protect these patients from the pain and side effects of opioids used for treatment. Many scales are available to indicate postoperative patient recovery. One of these is the quality of recovery-15 (QoR-15) recovery test, which was first applied by Stark et al. in 2013. We think that an ESPB applied from the sacral region will spread to the lumbar region by diffusion, affect the lumbar plexus, and provide complete analgesia in the ventral and dorsal regions of the hip by affecting the sacral plexus in the sacral region. The investigator's primary aim in this study is to evaluate the effect of sacral erector spinae plane block (S-ESPB) on the quality of recovery and healing after TKA through the QoR-15 score and to evaluate its effect on postoperative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable postoperative-pain

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

First Submitted

Initial submission to the registry

December 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

December 11, 2023

Last Update Submit

April 15, 2024

Conditions

Keywords

paininterfascial plan block.

Outcome Measures

Primary Outcomes (1)

  • Quality of recovery-15T

    The primary evaluation criteria will be the recording of QoR -15 scores, which indicate the quality of recovery of patients before and at 24 hours after surgery .

    One day

Study Arms (2)

control group

NO INTERVENTION

Group K IV to patients paracetamol 1 gr. It will be administered 3x1 + Dexketoprofen 50 mg 2x1. All patients will be administered 1mg/kg tramadol as rescue analgesic when NRS is 3 and above . 4mg IV to all patients with nausea and vomiting Ondansetron will be administered.

Sacral erektör spinae plane group

ACTIVE COMPARATOR

sacral erector spinae plane will be applied to patients in Group S

Other: sacral erectör spinae plane group

Interventions

sacral erectör spinae plane will be applied to patients in Group S

Sacral erektör spinae plane group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo unilateral THA
  • Spinal anesthesia
  • year-old patients
  • Patients with ASA I-IV
  • Patients who will stay in the hospital for at least 24 hours

You may not qualify if:

  • Patients who do not want to give consent
  • Patients under 18 years of age and over 80 years of age
  • Patients for whom regional anesthesia is contraindicated
  • Patients with confusion
  • Patients with ASA V and above
  • Patients with abnormal bleeding profile
  • Patients using anticoagulants
  • Patients with infection in the area to be treated
  • Emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist, the member of the Department of Anesthesiology, Konya City Hospital, M.D

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 24, 2024

Study Start

January 24, 2024

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations