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.
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.
Italy2 sites, 2 recruiting
- Not yet recruiting
Crotone Hospital
Crotone
Tommaso Sorrentino, MD, +393277038017, dr.sorrentinotommaso@gmail.com
- Recruiting
Crotone Hospital
Crotone
Tommaso Sorrentino, +393277038017, dr.sorrentinotommaso@gmail.com
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.
- Conditions
- Laparoscopy, Abdominal Surgery by Laparotomy
- 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 group | Role | What they receive |
|---|---|---|
| DRS block | Ultrasound-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.
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)
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
Duration of analgesia
First analgesia request
Measured: up to 48 hours
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.
- First posted14 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- San Giovanni di Dio Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Sorrentino, San Giovanni di Dio Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Deep Rectus Sheath (Preperitoneal) Block for Postoperative Analgesia in Abdominal Surgery: A Prospective Observational Clinical Study
- ClinicalTrials.gov ID
- NCT07586462
- Acronym / sponsor ID
- DRS block / DRS_Study
- Conditions
- Laparoscopy, Abdominal Surgery by Laparotomy
- Keywords
- rectus sheath, fascial blocks, Laparoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- San Giovanni di Dio HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRS block | – | Procedure: Other blocksUltrasound-guided Deep Rectus Sheath Block (preperitoneal block) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing abdominal surgery, either open or laparoscopic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other blocksFascial plane blocks (TAP, QL, ESP, Rectus sheath) | Procedure or surgery | DRS block |
Primary outcome
Quality of Recovery-15 (QoR-15) score
Time frame: 24 hours postoperatively
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
3 secondary outcomes
Postoperative pain
Time frame: 0-2-4-6-8-12-24-48 hours postoperatively
Duration of analgesia
Time frame: up to 48 hours
Complications
Time frame: up to 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.