NCT07064200

Brief Summary

This study investigates whether administering TAP blocks pre-incision provides superior postoperative pain control and reduces opioid use along with other medications compared to post-incision administration in patients undergoing elective abdominal surgeries.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jul 2025

Typical duration 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 Progress41%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

July 2, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 14, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

July 2, 2025

Last Update Submit

January 26, 2026

Conditions

Keywords

bariatric analgesia

Outcome Measures

Primary Outcomes (2)

  • Mean change in opioid consumption (MME) from index procedure to 90 days post-op

    Opioid dosage quantities will be measured in morphine milligram equivalents (MME)

    Up to 90 days post-operatively

  • Change in Pain Scores from index procedure on a numerical rating scale

    Patient-reported pain on a scale of 1-10.

    1, 3, 6, 24, 48, and 72 hours postoperatively

Secondary Outcomes (4)

  • 1. Total Opioid Consumption in MME from Surgery to 90 Days Postoperatively

    From end of surgery to 90 days post-op.

  • Patient Satisfaction Score with Postoperative Pain Management at Discharge

    At hospital discharge (within 3-5 days post-op)

  • Use of Non-Opioid Analgesics within 72 Hours

    From end of surgery to 72 hours post-op

  • Number of Participants with TAP Block-Related Adverse Events

    From TAP block administration to 90 days post-op.

Study Arms (2)

Pre-Incision

OTHER

TAP block administration pre-incision

Other: TAP Block

Post-Incision

OTHER

TAP block administration post-incision

Other: TAP Block

Interventions

the TAP block is a regional anesthesia technique that targets the somatic nerves supplying the anterior abdominal wall.

Post-IncisionPre-Incision

Eligibility Criteria

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

You may qualify if:

  • Adults aged between 18 and 65 years
  • Scheduled for elective bariatric surgery or other elective general abdominal surgeries
  • Proficient in English sufficient to understand study procedures and communicate effectively
  • Capable of providing informed consent

You may not qualify if:

  • Individuals under 18 years of age (minors)
  • Pregnant individuals
  • Prisoners
  • Individuals with cognitive impairments or otherwise unable to provide informed consent independently
  • Individuals with known allergies or contraindications to local anesthetics used in TAP blocks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College - NewYork-Presbyterian Hospital

New York, New York, 10065, United States

RECRUITING

Study Officials

  • Cheguevara Afaneh, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 14, 2025

Study Start

July 14, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

Shared Documents
STUDY PROTOCOL
Time Frame
beginning at 9 months and ending 36 months following article publication
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee (:learned intermediary:) identifies for this purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without the investigator support other than deposited metadata.

Locations