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.
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.
France2 sites, 2 recruiting
- Recruiting
CHR Metz Thionville Hopital de Mercy
Metz, Moselle, 57085
Antoine BECRET, MD, 387553069 ext. 0033, antoine.becret@chr-metz-thionville.fr
- Not yet recruiting
CHR Metz-Thionville Hopital Bel Air
Thionville, 57126
Arpiné EL NAR, PhD, 0033387557766, projet-recherche-clinique@chr-metz-thionville.fr
Colombe DUCHEMIN, MD
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 group | Role | What they receive |
|---|---|---|
| Thoracic epidural anesthesia | Active comparator | Epidural analgesia during midline laparotomy Receives: Drug: Epidural analgesia; Procedure: Laparotomy |
| Bilateral rectus sheath block | Experimental | Bilateral 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.
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)
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
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
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
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
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
Postoperative complications link to analgesic technique
Number of postoperative complication in both groups
Measured: Postoperative days 1, 2 and 3
The length of stay
Comparison of the length of stay between the two groups
Measured: at hospital discharge up to 30 days
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
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
Urinary catheterization
The time during which the patients are taking recourse to postoperative urinary catheterization
Measured: at hospital discharge up to 30 days
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
Failure to set up a catheter
Number of Failure to delivery catheter in both techniques
Measured: Postoperative day 1
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
Impact of premature discontinuation of local anesthetic perfusion
Number of premature discontinuation of local anesthetics
Measured: on day 0
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.
- First posted2 Aug 2021
- Study start11 Oct 2021
- Primary completion10 Oct 2028 (estimated)
- Study completion10 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaparotomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine BECRET, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block
- ClinicalTrials.gov ID
- NCT04985695
- Acronym / sponsor ID
- QORRECTCATH / 2021-01-CHRMT
- Conditions
- Laparotomy
- Keywords
- postoperative rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 10 Apr 2029 (estimated)
- First posted
- 2 Aug 2021 (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.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural anesthesia | Active comparator | Drug: Epidural analgesia, Procedure: LaparotomyEpidural analgesia during midline laparotomy |
| Bilateral rectus sheath block | Experimental | Drug: Bilateral rectus sheath block, Procedure: LaparotomyBilateral rectus sheath block during midline laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Epidural analgesiaAll 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. | Drug | Thoracic epidural anesthesia |
| Bilateral rectus sheath blockBilateral 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 | Drug | Bilateral rectus sheath block |
| LaparotomyA midline sub or supra umbilical laparotomy or xypho-pubian laparotomy | Procedure or surgery | Bilateral rectus sheath block, Thoracic epidural anesthesia |
Primary outcome
Change in total QoR-15 score
Time frame: Postoperative day 2
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).
15 secondary outcomes
Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery
Time frame: Postoperative days 1, and 3
Efficacy of postoperative analgesia
Time frame: Day 0 and Postoperative days 1, 2, 3 and 30
Impact of arterial hypotension
Time frame: Postoperative days 1, 2 and 3
Impact of orthostatic hypotension
Time frame: Postoperative days 1, 2 and 3
Occurrence of nausea and/or vomiting
Time frame: Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days
Postoperative complications link to analgesic technique
Time frame: Postoperative days 1, 2 and 3
The length of stay
Time frame: at hospital discharge up to 30 days
Return to normal bowel function
Time frame: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days
The quantity of morphine or equivalent
Time frame: Day 0 and Postoperative days 1, 2 and 3
Urinary catheterization
Time frame: at hospital discharge up to 30 days
Total distance covered
Time frame: Postoperative days 1, 2 and 3
Failure to set up a catheter
Time frame: Postoperative day 1
The time until the first raised
Time frame: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days
Impact of premature discontinuation of local anesthetic perfusion
Time frame: on day 0
Patient satisfaction and need for further consultation
Time frame: at hospital discharge up to 30 days and on postoperative day 30
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 16 Dec 2025.
- Derived from this study: PubMed 37221022Maury 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.
- Individual participant dataSharing planned: 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.
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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.
Antoine BECRET, MD principal investigator
CHR Metz Thionville Hopital de Mercy
2 sites in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.