NCT07855380

Brief Summary

The aim of this study is to evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress73%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of pain

    Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

    24 hours postoperatively

Secondary Outcomes (5)

  • Total fentanyl consumption

    Intraoperatively

  • Total opioid consumption

    24 hours postoperatively

  • Mean arterial pressure

    24 hours postoperatively

  • Heart rate

    24 hours postoperatively

  • Incidence of complications

    24 hours postoperatively

Study Arms (2)

Group 1

SHAM COMPARATOR

Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%.

Drug: Saline 0.9%

Group 2

EXPERIMENTAL

Patients will receive ultrasound guided transversalis fascia plane block.

Drug: Transversalis fascia plane block

Interventions

Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%.

Group 1

Patients will receive ultrasound guided transversalis fascia plane block.

Also known as: 20 ml of bupivacaine 0.25%
Group 2

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists (ASA) class I and II.
  • Age ≥ 18 and ≤ 65 Years.
  • Cancer patients for inguinal lymph node dissection.
  • Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.

You may not qualify if:

  • Patient refusal.
  • Local infection at the puncture site.
  • Coagulopathies with platelet count below 50,000 or an INR\>1.6.
  • Unstable cardiovascular disease.
  • History of psychiatric and cognitive disorders.
  • Patients allergic to medication used.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Ahmed S Abdelgalil, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anaesthesia and Pain Medicine National Cancer, Cairo University.

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations