NCT07738900

Brief Summary

This study aimed to compare the analgesic effect of bilateral ultrasound-guided modified thoracoabdominal nerve block with bilateral ultrasound-guided erector spinae plane block in abdominoplasty surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 25, 2026

Last Update Submit

July 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption

    Intravenous pethidine (0.5mg/kg) was taken every 12 hours as rescue analgesia.

    24 hours postoperatively

Secondary Outcomes (5)

  • Duration of analgesia

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

  • Cortisol level

    24 hours postoperatively

  • C-reactive protein (CRP) level

    24 hours postoperatively

  • Incidence of complications

    24 hours postoperatively

Study Arms (3)

Control group

ACTIVE COMPARATOR

Patients received only standard general anesthesia.

Drug: General Anaesthesia using intravenous propofol, fentanyl intravenous, and atracurium besylate

Modified thoracoabdominal nerve block group

EXPERIMENTAL

Patients received modified thoracoabdominal nerve block bilaterally

Drug: Modified thoracoabdominal nerve block using 25 mL of bupivacaine 0.25%

Erector spinae plane block group

EXPERIMENTAL

Patients received an erector spinae plane block bilaterally.

Drug: Erector spinae plane block using 25 mL of bupivacaine 0.25%

Interventions

Patients received only standard general anesthesia using intravenous propofol (2-3 mg/kg), fentanyl intravenous (1.5µ/kg) and atracurium besylate (0.6 mg/kg).

Control group

Patients received modified thoracoabdominal nerve block bilaterally using 25 mL of bupivacaine 0.25% and a lidocaine mixture (15 mL of bupivacaine 0.5% plus 5 mL of 2% lidocaine).

Modified thoracoabdominal nerve block group

Patients receive erector spinae plane block bilaterally using 25 mL of bupivacaine 0.25% and a lidocaine mixture (15 mL of bupivacaine 0.5% plus 5 mL of 2% lidocaine).

Erector spinae plane block group

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 21 and 60 years.
  • Both sexes.
  • American Society of Anesthesiologists physical status grade I and grade II.
  • Elective abdominoplasty operation.

You may not qualify if:

  • Patient refusal.
  • Local skin infection and sepsis at site of the block.
  • Known allergy to local anesthetic drugs.
  • Coagulopathy.
  • Psychiatric diseases.
  • Central or peripheral neurological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Interventions

Atracurium

Intervention Hierarchy (Ancestors)

BenzylisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesia and Surgical Intensive Care, Mansoura University, Egypt.

Study Record Dates

First Submitted

July 25, 2026

First Posted

July 31, 2026

Study Start

December 1, 2024

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

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