AzTrials
AzTrials

LaparotomyQORRECTCATHNCT04985695

Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

A study testing Epidural analgesia, Bilateral rectus sheath block and Laparotomy in people with Laparotomy, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.

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

Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Laparotomy
What is being tested?
Epidural analgesia, Bilateral rectus sheath block and Laparotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesFrance
Study dates
11 Oct 2021to 10 Apr 2029
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy
  • Have given an informed written consent
  • Able to read and understand french language
  • Affiliation to a social security system

Who cannot join

  • Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA (coagulation disorders, progressive neurological disease, or severe spinal disorder),
  • Epidural analgesia contraindication
  • With impossibility to set up bilateral rectus sheath block
  • Participation in another clinical study
  • Pregnant women
  • Patients deprived of their liberty by a judicial or administrative decision,
  • Patients undergoing psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code

Trial locations and contacts

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

Arpiné EL NAR, PhD contact

0033387557766

arpine.el-nar@chr-metz-thionville.fr

France2 sites, 2 recruiting

  • CHR Metz Thionville Hopital de Mercy

    Metz, Moselle, 57085

    Antoine BECRET, MD, 387553069 ext. 0033, antoine.becret@chr-metz-thionville.fr

    Recruiting

  • CHR Metz-Thionville Hopital Bel Air

    Thionville, 57126

    Arpiné EL NAR, PhD, 0033387557766, projet-recherche-clinique@chr-metz-thionville.fr

    Colombe DUCHEMIN, MD

    Not yet recruiting

Other trials in France

About this study

Official title: Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block

Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters in the sheath of the rectus abdominis muscles.

Read the detailed description

Implementation of fast-track rehabilitation surgery was essential in patient care, specially in oncological point.

In this way, uses of the technic of local anesthesia, include epidural analgesia, was essential, but this one is associated with few complications. Emergence of new technic of anesthesia with a comparative analgesia and without side effects should be a better alternative than epidural analgesia. Thus, bilateral rectus sheath block has been reported to be effective in management of postoperative pain.

After signing of the informed consent, two postoperative analgesia techniques were investigated in patients undergoing midline laparotomy.

The main objective of this study is to compare the influence of analgesic technique on the Quality of Recovery-15 score. The study design was a prospective, randomized trial with 2 parallel arms (epidural analgesia vs bilateral rectus sheath block).

Conditions
Laparotomy
Being tested
Epidural analgesia, Bilateral rectus sheath block, Laparotomy
Keywords
postoperative rehabilitation

What participants receive

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

  • Epidural analgesiaDrug

    All patients received local anesthesia (3-5 ml of 2% Lidocaine). During the preoperative induction of anaesthesia a catheter was inserted 4cm into the epidural space. The catheter will be load during the intervention (0.1 ml/kg/h). In postoperative situation, a patient controlled epidural analgesia was introduced with a debit adapted to the arterial pressure.

  • Bilateral rectus sheath blockDrug

    Bilateral rectus sheath block was performed Under general anesthesia and with ultrasound guidance. Rectus sheath block was inserted on each side of the abdomen. All patients received ropivacaine through elastomeric pump

  • LaparotomyProcedure or surgery

    A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy

Study groups in NCT04985695
Study groupRoleWhat they receive
Thoracic epidural anesthesiaActive comparatorEpidural analgesia during midline laparotomy
Receives: Drug: Epidural analgesia; Procedure: Laparotomy
Bilateral rectus sheath blockExperimentalBilateral rectus sheath block during midline laparotomy
Receives: Drug: Bilateral rectus sheath block; Procedure: Laparotomy

What is being measured

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

  1. Change in total QoR-15 score

    The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0="none of the time" to 10="all the time"; for negative items the scoring was reversed).

    Measured: Postoperative day 2

Secondary outcomes (15)

  1. Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery

    The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0="none of the time" to 10="all the time"; for negative items the scoring was reversed).

    Measured: Postoperative days 1, and 3

  2. Efficacy of postoperative analgesia

    The efficacy of postoperative analgesia was compared between the two groups with the visual analog scale (VAS). The VAS intensity rating consisted of a 100-mm line with the end points no pain (0 mm) and worst pain (100 mm). Study participants were asked to evaluated with a mark on the line their current pain intensity. The difference between each postoperative treatment VAS score was compared.

    Measured: Day 0 and Postoperative days 1, 2, 3 and 30

  3. Impact of arterial hypotension

    The impact of arterial hypotension was compared between the two groups with the arterial pressure value before and after laparotomy

    Measured: Postoperative days 1, 2 and 3

  4. Impact of orthostatic hypotension

    The impact of orthostatic hypotension was compared between the two groups with the arterial pressure value before and after surgery.

    Measured: Postoperative days 1, 2 and 3

  5. Occurrence of nausea and/or vomiting

    The effect of analgesic technique on nausea and/or vomiting is calculated on the basis of the number of anti-vomiting prescribed.

    Measured: Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days

  6. Postoperative complications link to analgesic technique

    Number of postoperative complication in both groups

    Measured: Postoperative days 1, 2 and 3

  7. The length of stay

    Comparison of the length of stay between the two groups

    Measured: at hospital discharge up to 30 days

  8. Return to normal bowel function

    Delay in hours to promotes normal digestive activity. The included the times to recovery the first bowel sounds, first anal exhaust and defecation.

    Measured: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days

  9. The quantity of morphine or equivalent

    The quantity of morphine or equivalent administered during the 48 first hours in both groups

    Measured: Day 0 and Postoperative days 1, 2 and 3

  10. Urinary catheterization

    The time during which the patients are taking recourse to postoperative urinary catheterization

    Measured: at hospital discharge up to 30 days

  11. Total distance covered

    Compare the impact of postoperative analgesia in Walking distance (meter) within days following the operation

    Measured: Postoperative days 1, 2 and 3

  12. Failure to set up a catheter

    Number of Failure to delivery catheter in both techniques

    Measured: Postoperative day 1

  13. The time until the first raised

    Delay before the first raised in hours

    Measured: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days

  14. Impact of premature discontinuation of local anesthetic perfusion

    Number of premature discontinuation of local anesthetics

    Measured: on day 0

  15. Patient satisfaction and need for further consultation

    Satisfaction questionnaire

    Measured: at hospital discharge up to 30 days and on postoperative day 30

Timeline

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

  1. First posted2 Aug 2021
  2. Study start11 Oct 2021
  3. Primary completion10 Oct 2028 (estimated)
  4. Study completion10 Apr 2029 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04985695
Sponsor's protocol ID
2021-01-CHRMT
Acronym
QORRECTCATH
Status last verified
Oct 2025
First submitted
8 Jul 2021
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences.

Publications

  • Maury T, Elnar A, Marchionni S, Frisoni R, Goetz C, Becret A. Effect of rectus sheath anaesthesia versus thoracic epidural analgesia on postoperative recovery quality after elective open abdominal surgery in a French regional hospital: the study protocol of a randomised controlled QoR-RECT-CATH trial. BMJ Open. 2023 May 23;13(5):e069736. doi: 10.1136/bmjopen-2022-069736.

    PubMed 37221022

Questions about this trial

What is this clinical trial studying?

A study testing Epidural analgesia, Bilateral rectus sheath block and Laparotomy in people with Laparotomy, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.

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 4 inclusion and 7 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 16 Dec 2025. 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 France. 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 Arpiné EL NAR, PhD (0033387557766, arpine.el-nar@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in total QoR-15 score (time frame: Postoperative day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04985695, which also lists 1 linked publication.

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 16 Dec 2025.

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