NCT04920994

Brief Summary

This study will be conducted to evaluate efficacy of ultrasound guided modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) for postoperative analgesia in major abdominal surgeries in comparison to subcostal transverse abdominis plane (SCTAP) block. It is hypothesized that M-TAPA block will be advantageous to SCTAP block as a promising effective alternative for analgesia for major abdominal surgeries with fewer side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

June 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 13, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

June 3, 2021

Last Update Submit

July 8, 2022

Conditions

Abdominal Surgery

Keywords

Thoracoabdominal nerve block

Outcome Measures

Primary Outcomes (1)

  • Total analgesic requirements of morphine

    The amount of morphine consumption in milligrams given as a rescue analgesia

    Up to 24 hours after the procedure

Secondary Outcomes (5)

  • Improvement in pain scores by Visual analogue scale (VAS)

    Up to 24 hours after the procedure

  • Duration for the first analgesic request

    Up to 24 hours after the procedure

  • Changes in heart rate

    Up to 24 hours after the procedure

  • Changes in mean arterial blood pressure

    Up to 24 hours after the procedure

  • Incidence of adverse effects

    Up to 24 hours after the procedure

Study Arms (2)

Group A (M-TAPA )

ACTIVE COMPARATOR

Ultrasound-guided M-TAPA block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

Procedure: M-TAPA blockDrug: Bupivacaine Hydrochloride

Group B (SCTAP)

ACTIVE COMPARATOR

Ultrasound-guided SCTAP block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

Procedure: SCTAP blockDrug: Bupivacaine Hydrochloride

Interventions

M-TAPA blockPROCEDURE

A high-frequency linear ultrasound probe will be used, probe will be placed on the costochondral angle in the sagittal plane and angled deeply to view the lower aspect of the chondrium in the midline, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced into the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.

Also known as: Ultrasound guided block
Group A (M-TAPA )
SCTAP blockPROCEDURE

A high-frequency linear ultrasound probe will be placed obliquely on the upper abdominal wall, along the subcostal margin near the midline. After identifying the rectus abdominis muscle, the ultrasound probe will be gradually moved laterally along the subcostal margin until the transversus abdominis muscle will be identified lying posterior to the rectus muscle, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced medially and directed towards the transversus abdominis plane until its tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles on entering the neurofascial plane. The same procedure will be repeated on the contralateral side.

Also known as: Ultrasound guided block
Group B (SCTAP)
Bupivacaine HydrochlorideDRUG

20 ml 0.25% bupivacaine will be injected after the negative aspiration test.

Also known as: Marcaine
Group A (M-TAPA )Group B (SCTAP)

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiology (ASA) I and II patients.
  • Scheduled for elective major abdominal surgeries.

You may not qualify if:

  • Patient's refusal.
  • Altered mental status or un-cooperative patients.
  • History of known sensitivity to the used anesthetics.
  • Bleeding or coagulation diathesis.
  • Infection at the injection site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Sameh M El-Sherbiny, MD

    Mansoura Faculty of Medicine

    PRINCIPAL INVESTIGATOR

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
SPONSOR INVESTIGATOR
PI Title
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 10, 2021

Study Start

August 13, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

July 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)