NCT06224179

Brief Summary

Inadequately managed acute pain following abdominal surgery originates from somatic pain signals in the abdominal wall and is linked to various unfavorable postoperative outcomes. These consequences encompass patient distress, respiratory complications, delirium, myocardial ischemia, extended hospital stays, an elevated risk of chronic pain, heightened analgesic consumption, delayed bowel function, and an increased need for rescue analgesics. This study aims to assess the postoperative analgesic efficacy of ultrasound-guided Transversus Abdominis Plane (TAP) block using oblique subcostal and posterior approaches in hepatectomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
unknown

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

January 17, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

January 17, 2024

Last Update Submit

January 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative analgesia (VAS) during the 1st 24 hours in ICU

    Pain will be assessed on admission and at 2, 4, 8, 12 and 24 hours at rest and with passive flexion of hip and knee joint using visual analogue scale (VAS) ranging from 0 for no pain to 10 for worst pain.

    24 hours

Study Arms (2)

Group A

EXPERIMENTAL

Group A received ultrasound guided subcostal TAP block with 30 ml of local anesthetics and additives

Procedure: ultrasound guided subcostal TAP block

Group B

EXPERIMENTAL

Group B received ultrasound guided both subcostal and posterior TAP block with 30 ml of local anesthetics and additives at each side

Procedure: ultrasound guided combined posterior and subcostal TAP block

Interventions

patients will be randomly divided into two groups using a computer generated random number chart. Group A received ultrasound guided subcostal TAP block,

Group A

patients will be randomly divided into two groups using a computer generated random number chart. Group B received ultrasound guided combined posterior and subcostal TAP block,

Group B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I and II patients. aged 18 to 50 years. 70 to 80 kg.

You may not qualify if:

  • patients under 18 years of age.
  • History of Allergic reactions to study drugs.
  • Opioid or analgesic abuse, and chronic treatment with opioids, or non-steroidal anti-inflammatory drugs.
  • History of bleeding tendency or coagulopathy .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ahmed El-Dolah, lecturer of Anesthesia

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 25, 2024

Study Start

February 1, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01