NCT05448495

Brief Summary

To compare the analgesic efficacy of posterior TAP block versus ESPB after PCNL surgery. The hypothesis is that posterior TAP block, as a part of multimodal analgesia, will reduce pain and opioid consumption like ESPB

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

July 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

July 2, 2022

Last Update Submit

July 13, 2022

Conditions

Keywords

Percutaneous nephrolithotomyErector spinae plane blockTransversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

  • The time to first call rescue analgesia

    From end of surgery till 24 hours

Study Arms (2)

Posterior TAP block

EXPERIMENTAL
Other: Posterior TAP block

ESPB

ACTIVE COMPARATOR
Other: ESPB

Interventions

Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \[0.5 mcg\\kg\] + 2ml dexamethasone \[0.1mg\\kg)\] will be injected at the plane between internal oblique and transversus abdominis near the aponeurosis at the posterior axillary line.

Also known as: Posterior transversus abdominis plane block
Posterior TAP block
ESPBOTHER

Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \[0.5 mcg\\kg\] + 2ml dexamethasone \[0.1mg\\kg)\] will be injected at T9 erector spinae plane

Also known as: Erector spinae plane block
ESPB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for PCNL under general anesthesia
  • ASA status I-II

You may not qualify if:

  • Contraindications to regional block (coagulopathy, infection at the needle insertion site or known allergy to amide local anesthetics)
  • Patient who has difficulty understanding the study protocol or patient refusal.
  • Chronic respiratory disease patients.
  • Diabetic patients.
  • Body mass index (BMI) \> 30 Kg/m2
  • Routine corticosteroids, pain medication, or anticonvulsant.
  • Psychiatric diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 2, 2022

First Posted

July 7, 2022

Study Start

July 13, 2022

Primary Completion

August 15, 2023

Study Completion

September 15, 2023

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations