NCT07586462

Brief Summary

The goal of this observational study is to learn about the effectiveness of the Deep Rectus Sheath (Preperitoneal) block in patients undergoing abdominal surgery. The main question it aims to answer is: Does the Deep Rectus Sheath block improve postoperative recovery and pain control compared to standard care or other fascial plane blocks in patients undergoing abdominal surgery? Participants undergoing open or laparoscopic abdominal surgery as part of their routine clinical care will receive analgesic management according to standard practice, which may include systemic analgesia alone, Deep Rectus Sheath block, or other fascial plane blocks (such as TAP, ESP, or QL), depending on anesthesiologist choice. Postoperative outcomes will be collected prospectively, including quality of recovery (QoR-15 at 24 hours), pain scores at rest and during movement up to 48 hours, analgesic consumption, time to first analgesic request, mobilization time, and occurrence of complications.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress25%
May 2026May 2027

Study Start

First participant enrolled

May 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 4, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

rectus sheathfascial blocksLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery-15 (QoR-15) score

    The Quality of Recovery-15 (QoR-15) is a validated patient-reported outcome measure designed to assess the quality of postoperative recovery across multiple dimensions of physical and psychological well-being. The questionnaire consists of 15 items, each scored on an 11-point numerical scale, resulting in a total score ranging from: Minimum score: 0 → extremely poor quality of recovery Maximum score: 150 → excellent quality of recovery Higher QoR-15 scores indicate a better postoperative recovery experience. The questionnaire evaluates five key domains: Pain Physical comfort Physical independence Psychological support Emotional state

    24 hours postoperatively

Secondary Outcomes (3)

  • Postoperative pain

    0-2-4-6-8-12-24-48 hours postoperatively

  • Duration of analgesia

    up to 48 hours

  • Complications

    up to 48 hours

Study Arms (1)

DRS block

Ultrasound-guided Deep Rectus Sheath Block (preperitoneal block)

Procedure: Other blocks

Interventions

Other blocksPROCEDURE

Fascial plane blocks (TAP, QL, ESP, Rectus sheath)

DRS block

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing abdominal surgery, either open or laparoscopic

You may qualify if:

  • Age ≥ 18 years
  • Patients undergoing abdominal surgery, either open or laparoscopic
  • ASA physical status I-III
  • Neuraxial or general anesthesia according to standard clinical practice
  • Provision of informed consent to participate in the study

You may not qualify if:

  • Refusal to provide informed consent
  • Contraindications to locoregional anesthesia
  • Known allergy to local anesthetic agents
  • Coagulation disorders or incompatible anticoagulant therapy
  • Infection at the injection site
  • Cognitive impairment preventing reliable assessment of outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Crotone Hospital

Crotone, Italy

NOT YET RECRUITING

Crotone Hospital

Crotone, Italy

RECRUITING

Central Study Contacts

Tommaso Sorrentino, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 14, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations