Postoperative PainNCT05259345
Comparison of SE-TAP, M-TAPA, and Rectus Sheath Block in Abdominal Surgeries
A study testing Bilateral SE-TAP, Bilateral M-TAPA and Bilateral RSB in people with Postoperative Pain, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomised controlled study is to compare the effects of three different fascial plane block [subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block, modified thoracoabdominal nerves block through perichondrial approach (M-TAPA), and rectus sheath block (RSB)] on postoperative pain… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bilateral SE-TAP, Bilateral M-TAPA and Bilateral RSB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2022to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology physical classification I-III
- Scheduled for elective laparotomy with a midline incision
Who cannot join
- Not agree to participate in the study
- Have mental status disorders
- Inability to communicate
- Known bleeding and/or coagulation disorders
- Infection at injection site
- Chronic opioid intake
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Faculty of Medicine
Eskişehir, 26040
About this study
Official title: Comparison of Subcostal Exterior Semilunaris Transverses Abdomens, Modified Thoracoabdominal Nerves Block Through Perichondrial Approach, and Rectus Sheath Block in Patients Undergoing Major Abdominal Surgeries
The aim of this randomised controlled study is to compare the effects of three different fascial plane block [subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block, modified thoracoabdominal nerves block through perichondrial approach (M-TAPA), and rectus sheath block (RSB)] on postoperative pain levels and opioid consumption in patients undergoing major abdominal surgeries with midline incision.
Read the detailed description
In last decade,ultrasound guided truncal fascial plane blocks such as transverses abdominis plane (TAP) block and rectus sheath block (RSB) have become popular as a part of postoperative multimodal analgesia for abdominal surgeries as the techniques are simple and the target sites are easily identify. Furthermore, the number of newly defined block techniques is daily increasing like M-TAPA and SE-TAP block.
The rectus sheath block (RSB) is an old technique that suite midline incisions and provides analgesia for somatic pain. The local anesthetic is injected into the space between the posterior wall of the rectus abdominis muscle and its sheath, to block the anterior branches of the thoracoabdominal nerves. It has been suggested that both anterior and lateral branches of the T5-T12 thoracoabdominal nerves are blockade in M-TAPA and SE-TAP blocks. So, they may provide better analgesia and quality of recovery for major abdominal surgeries due to presence of drains. However, the extent of the local anaesthetic diffusion and the dermatomal levels are not clear, and there is no randomised clinical trial about these new techniques, to our knowledge.
Patients and Methods: This is a prospective, randomised, double-blind clinical study; carry out on 120 patients schedule for elective major abdominal surgery with midline incision. While the fascia is closed, 1 g paracetamol and 1 mg/kg tramadol will be administered routinely to all patients for postoperative multimodal analgesia. At the end of surgery, patients will be randomly allocated into three groups (40 patients each); bilateral SE-TAP block in Group S, bilateral RSB in Group R, and bilateral M-TAPA block in Group M will be performed under ultrasound guidance. Patient controlled analgesia with intravenous morphine will be started at the recovery room. Postoperative pain levels, opioid consumption, and quality of recovery will be questioned and recorded at the first postoperative day.
- Conditions
- Postoperative Pain
- Being tested
- Bilateral SE-TAP, Bilateral M-TAPA, Bilateral RSB
- Keywords
- fascial plane blocks, postoperative pain, opioid consumption, quality of recovery, abdominal surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral SE-TAPProcedure or surgery
Also called Ultrasound guided bilateral subcostal exterior semilunaris transversus abdomens plane block
A 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given between the internal oblique and transversus abdominis muscles toward the lateral border of the semilunar along the costal margin.
Bilateral M-TAPAProcedure or surgery
Also called Ultrasound guided bilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)
A 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given into the layer between the transverse abdominal muscle and the inferior plane of the costal cartilage at the midclavicular line, in the sagittal plane.
Bilateral RSBProcedure or surgery
Also called Ultrasound guided bilateral rectus sheath block
A 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given between the rectus muscle and posterior rectus sheath bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Group SE-TAP block | Active comparator | Bilateral subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) Receives: Procedure: Bilateral SE-TAP |
| Group M-TAPA block | Active comparator | Bilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) Receives: Procedure: Bilateral M-TAPA |
| Group RS block | Active comparator | Bilateral rectus sheath block will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) Receives: Procedure: Bilateral RSB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Quality of Recovery-40 (QoR-40), a 40-item questionnaire that provides a global score and subscores across five dimensions; patient support, comfort, emotions, physical independence, and pain (minimum score of 40 and maximum of 200).
Measured: At postoperative 24th hours
Secondary outcomes (2)
Postoperative pain
Numeric rating scale pain from 0 (no pain) to 10 (worst pain).
Measured: At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)
Opioid consumption
Morphine consumption
Measured: At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start28 Feb 2022
- Primary completion28 Feb 2024 (estimated)
- Study completion15 Mar 2024 (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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ERDOGAN KAYHAN, Inonu University
- Investigators
- Gulay Erdogan Kayhan, Professor, Principal investigator, Eskisehir Osmangazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259345
- Sponsor's protocol ID
- ESOGU anaesthesia
- Status last verified
- Apr 2023
- First submitted
- 14 Feb 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bakshi SG, Mapari A, Shylasree TS. REctus Sheath block for postoperative analgesia in gynecological ONcology Surgery (RESONS): a randomized-controlled trial. Can J Anaesth. 2016 Dec;63(12):1335-1344. doi: 10.1007/s12630-016-0732-9. Epub 2016 Sep 14.
PubMed 27638294
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subcostal Exterior Semilunaris Transverses Abdomens, Modified Thoracoabdominal Nerves Block Through Perichondrial Approach, and Rectus Sheath Block in Patients Undergoing Major Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT05259345
- Acronym / sponsor ID
- ESOGU anaesthesia
- Conditions
- Postoperative Pain
- Keywords
- fascial plane blocks, postoperative pain, opioid consumption, quality of recovery, abdominal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 28 Feb 2022 (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 aim of this randomised controlled study is to compare the effects of three different fascial plane block [subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block, modified thoracoabdominal nerves block through perichondrial approach (M-TAPA), and rectus sheath block (RSB)] on postoperative pain levels and opioid consumption in patients undergoing major abdominal surgeries with midline incision.
Detailed description
In last decade,ultrasound guided truncal fascial plane blocks such as transverses abdominis plane (TAP) block and rectus sheath block (RSB) have become popular as a part of postoperative multimodal analgesia for abdominal surgeries as the techniques are simple and the target sites are easily identify. Furthermore, the number of newly defined block techniques is daily increasing like M-TAPA and SE-TAP block.
The rectus sheath block (RSB) is an old technique that suite midline incisions and provides analgesia for somatic pain. The local anesthetic is injected into the space between the posterior wall of the rectus abdominis muscle and its sheath, to block the anterior branches of the thoracoabdominal nerves. It has been suggested that both anterior and lateral branches of the T5-T12 thoracoabdominal nerves are blockade in M-TAPA and SE-TAP blocks. So, they may provide better analgesia and quality of recovery for major abdominal surgeries due to presence of drains. However, the extent of the local anaesthetic diffusion and the dermatomal levels are not clear, and there is no randomised clinical trial about these new techniques, to our knowledge.
Patients and Methods: This is a prospective, randomised, double-blind clinical study; carry out on 120 patients schedule for elective major abdominal surgery with midline incision. While the fascia is closed, 1 g paracetamol and 1 mg/kg tramadol will be administered routinely to all patients for postoperative multimodal analgesia. At the end of surgery, patients will be randomly allocated into three groups (40 patients each); bilateral SE-TAP block in Group S, bilateral RSB in Group R, and bilateral M-TAPA block in Group M will be performed under ultrasound guidance. Patient controlled analgesia with intravenous morphine will be started at the recovery room. Postoperative pain levels, opioid consumption, and quality of recovery will be questioned and recorded at the first postoperative day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group SE-TAP block | Active comparator | Procedure: Bilateral SE-TAPBilateral subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) |
| Group M-TAPA block | Active comparator | Procedure: Bilateral M-TAPABilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) |
| Group RS block | Active comparator | Procedure: Bilateral RSBBilateral rectus sheath block will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology physical classification I-III
- Scheduled for elective laparotomy with a midline incision
Key exclusion criteria (6 listed)
- Not agree to participate in the study
- Have mental status disorders
- Inability to communicate
- Known bleeding and/or coagulation disorders
- Infection at 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 |
|---|---|---|
| Bilateral SE-TAPAlso: Ultrasound guided bilateral subcostal exterior semilunaris transversus abdomens plane blockA 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given between the internal oblique and transversus abdominis muscles toward the lateral border of the semilunar along the costal margin. | Procedure or surgery | Group SE-TAP block |
| Bilateral M-TAPAAlso: Ultrasound guided bilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)A 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given into the layer between the transverse abdominal muscle and the inferior plane of the costal cartilage at the midclavicular line, in the sagittal plane. | Procedure or surgery | Group M-TAPA block |
| Bilateral RSBAlso: Ultrasound guided bilateral rectus sheath blockA 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given between the rectus muscle and posterior rectus sheath bilaterally. | Procedure or surgery | Group RS block |
Primary outcome
Quality of Recovery
Time frame: At postoperative 24th hours
Quality of Recovery-40 (QoR-40), a 40-item questionnaire that provides a global score and subscores across five dimensions; patient support, comfort, emotions, physical independence, and pain (minimum score of 40 and maximum of 200).
2 secondary outcomes
Postoperative pain
Time frame: At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)
Opioid consumption
Time frame: At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Results publication: PubMed 27638294Bakshi SG, Mapari A, Shylasree TS. REctus Sheath block for postoperative analgesia in gynecological ONcology Surgery (RESONS): a randomized-controlled trial. Can J Anaesth. 2016 Dec;63(12):1335-1344. doi: 10.1007/s12630-016-0732-9. Epub 2016 Sep 14.
- 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. This study is not recruiting at the moment.
Gulay Erdogan Kayhan, Professor principal investigator
Eskisehir Osmangazi University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral SE-TAP, Bilateral M-TAPA and Bilateral RSB in people with Postoperative Pain, run by Inonu University at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (time frame: At postoperative 24th hours). 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 NCT05259345, 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 7 Apr 2023.