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LaparoscopyDRS blockNCT07586462

Deep Rectus Sheath (DRS) Block in Abdominal Surgery

An observational study of Laparoscopy and Abdominal Surgery by Laparotomy, run by San Giovanni di Dio Hospital at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Laparoscopy, Abdominal Surgery by Laparotomy
What is being tested?
Other blocks
Type of treatment
Surgery or procedure
How many people
60 participants
Where
2 sitesItaly
Study dates
May 2026to May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients undergoing abdominal surgery, either open or laparoscopic

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tommaso Sorrentino, MD contact

+393277038017

dr.sorrentinotommaso@gmail.com

Italy2 sites, 2 recruiting
  • Crotone Hospital

    Crotone

    Tommaso Sorrentino, MD, +393277038017, dr.sorrentinotommaso@gmail.com

    Not yet recruiting
  • Crotone Hospital

    Crotone

    Tommaso Sorrentino, +393277038017, dr.sorrentinotommaso@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: The Effectiveness of the Deep Rectus Sheath (Preperitoneal) Block for Postoperative Analgesia in Abdominal Surgery: A Prospective Observational Clinical Study

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.

Read the detailed description

This prospective, observational, non-interventional clinical study aims to evaluate postoperative recovery and analgesic outcomes in adult patients undergoing abdominal surgery (open or laparoscopic) who receive different perioperative analgesic strategies as part of routine clinical care.

The study focuses on the Deep Rectus Sheath (DRS) block, also referred to as the preperitoneal block, a recently described ultrasound-guided technique involving injection of local anesthetic beneath the posterior rectus sheath into the preperitoneal space. This approach is hypothesized to provide broader analgesia compared with the conventional rectus sheath block by targeting not only somatic afferents of the anterior abdominal wall but also the richly innervated parietal peritoneum, potentially contributing to improved control of both somatic and visceral components of postoperative pain.

Patients will not be randomized. Instead, they will be managed according to standard clinical practice and subsequently categorized based on the analgesic strategy received: (A) standard systemic analgesia alone; (B) DRS block combined with standard care; or (C) alternative or additional fascial plane blocks (such as transversus abdominis plane [TAP], erector spinae plane [ESP], or quadratus lumborum [QL] blocks) combined with standard care. Detailed data will be recorded on the type of block performed, timing (pre-incision or postoperative), technique, local anesthetic dose and concentration, and use of adjuvants.

All patients will receive multimodal postoperative analgesia according to institutional protocols, typically including scheduled non-opioid analgesics with opioids reserved for rescue therapy. The study does not alter clinical management.

The primary outcome is postoperative quality of recovery, assessed using the Quality of Recovery-15 (QoR-15) score at 24 hours after surgery. Secondary outcomes include postoperative pain scores at rest and during movement at predefined time points up to 48 hours, patient satisfaction (Likert scale), total analgesic consumption, time to first rescue analgesic request (duration of analgesia), time to first mobilization, incidence of postoperative nausea and vomiting, use of antiemetics, and occurrence of complications.

Safety assessment will include monitoring for block-related complications during and immediately after the procedure (e.g., vascular puncture, paresthesia, pain, local anesthetic systemic toxicity), early postoperative complications, and delayed adverse events, including neurological symptoms evaluated up to 7 days after surgery.

The study is exploratory in nature, with sample size based on feasibility, and is expected to be completed within 12 months. Statistical analysis will include comparisons of baseline characteristics and outcomes between groups using appropriate parametric or non-parametric tests, as well as linear mixed-effects models for repeated measures over time. A p-value <0.05 will be considered statistically significant.

Being tested
Other blocks
Keywords
rectus sheath, fascial blocks, Laparoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Other blocksProcedure or surgery

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

Study groups in NCT07586462
Study groupRoleWhat they receive
DRS blockUltrasound-guided Deep Rectus Sheath Block (preperitoneal block)
Receives: Procedure: Other blocks

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 hours postoperatively

Secondary outcomes (3)
  1. Postoperative pain

    The Numerical Rating Scale (NRS) is a validated and widely used tool for the assessment of pain intensity in clinical practice and perioperative research.

    Patients are asked to rate their pain on a numerical scale ranging from:

    0 → no pain 10 → worst pain imaginable

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

  2. Duration of analgesia

    First analgesia request

    Measured: up to 48 hours

  3. Complications

    Toxicity, PONV, others

    Measured: up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07586462
Sponsor's protocol ID
DRS_Study
Other IDs
No other
Acronym
DRS block
Status last verified
May 2026
First submitted
4 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Laparoscopy and Abdominal Surgery by Laparotomy, run by San Giovanni di Dio Hospital at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tommaso Sorrentino, MD (+393277038017, dr.sorrentinotommaso@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery-15 (QoR-15) score (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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