AnalgesiaNCT05253079
Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Open Liver Resection Surgery
A study testing subcostal transversus plane block and erector spinae plane block in people with Analgesia and Hepatic Resection Surgery, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Liver resection surgery is a common surgical procedure which is performed on patients with benign, malignant or metastatic hepatic tumor as well as for living liver donor. Liver resection surgery is usually performed through either right subcostal or inversed L-shaped incision; both approaches are associated with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Hepatic Resection Surgery
- What is being tested?
- subcostal transversus plane block and erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (>18 years),
- ASA-physical status I-III
- undergoing open liver resection surgery for either primary/metastatic hepatic malignancy, biliary tract malignancy, or benign hepatic tumor
Who cannot join
- history of allergy to any of the study drugs,
- a body mass index (BMI) <18 or ≥ 35 kg/m2,
- coagulopathy (INR >1.5 and/or platelet count <70000/µL),
- local infection,
- history of chronic pain or regular opioid use;
- inability to comprehend the Numeric Rating Scale (NRS),
Show all 10Show fewer
- liver resection combined with a second surgical procedure, laparoscopic resections,
- pregnant or lactating women.
- Patients with complicated procedures
- those needing postoperative ventilation will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alaini Hospital
Cairo, 11562
Anesthesia, Pain Management and Surgical ICU Department, 00201222224057, Anesthesia.kasralainy@gmail.com
About this study
Official title: Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Patients Undergoing Open Liver Resection Surgery: A Randomized Controlled Trial
Liver resection surgery is a common surgical procedure which is performed on patients with benign, malignant or metastatic hepatic tumor as well as for living liver donor. Liver resection surgery is usually performed through either right subcostal or inversed L-shaped incision; both approaches are associated with a significant postoperative pain which requires intensive analgesic plan to facilitate early mobilization and minimize complications.
There are various lines for pain management in liver resection surgery such as systemic analgesic drugs, neuraxial blocks (e.g., thoracic epidural analgesia) and transversus abdominis plane [TAP] block).
Read more
Systemic analgesic drugs are nearly constantly used in liver resection. However, being systemically administered, these drugs have many side effects on many organs and cannot totally eliminate postoperative pain. Thoracic epidural block is commonly associated with hypotension; furthermore, its use has other limitations such as delaying postoperative mobilization and possible hematoma and cord compression in patients with coagulopathy which is expected following liver resection. Therefore, there had been an increased interest in the use of abdominal field blocks to avoid disadvantages of neuraxial blocks and minimize the use of parenteral analgesic drugs.
TAP block is one of the classic field blocks which is extensively used in laparotomies including liver resection. However, the lack of visceral pain control TAP block influences the quality of its analgesic effect in this type of patients. Nevertheless, TAP block, namely the subcostal approach, is still the recommended field block in the latest procedure-specific recommendations for pain management in liver resection as it is the only block which showed good evidence.
In recent years, there has been increased interest in a newer field block, the erector spinae plane block (ESPB), due its easy performance and the possible coverage of visceral pain in addition to the somatic pain. ESPB showed promising results in liver resection surgery. ESBP was superior to TAP block in various abdominal surgeries. However, its analgesic efficacy had not been previously compared in relation to TAP in patients undergoing open liver resection surgery.
Read the detailed description
An independent research assistant will be responsible for opening the envelope and drug preparation with no further involvement in the study. The local anesthetic solution preparation will be as follow; 2 syringes of 20 ml of 0.25% isobaric bupivacaine.
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and pre-medication drugs will be delivered (metoclopramide 10 mg, and omeprazole 40 mg).
General anesthesia will be induced by 2-3 mg/kg propofol and 1-2 mcg/kg fentanyl. Tracheal intubation by direct laryngoscopy will be facilitated by atracurium 0.5 mg/kg. Anesthesia will be maintained by 2-2.5% sevoflurane and 0.1 mg/kg/20min atracurium.
After induction of anesthesia, patients will receive their assigned intervention.
Intraoperative analgesic management Morphine boluses (titrated 0.05 mg/kg boluses till response) will be given in case of inadequate analgesia (heart rate/mean blood pressure increase by 20% from the baseline) Intraoperative fluid and hemodynamic management will be according to the discretion of the attending anesthetist.
At the end of the surgery, all patients will receive intravenous paracetamol (1 g) and ketorolac (30 mg) before the extubation.
Postoperative care All patients will receive regular intravenous paracetamol 1 g/6hours and ketorolac 30 mg/8hours. Pain assessments using Numerical Rating Scale (NRS) will be performed at rest and during cough at 0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room. If NRS score is > 3 intravenous titration of 2 mg morphine is given slowly to be repeated after 30 minutes if pain persisted. If other opioids are given, morphine equivalent dose will be calculated using opioids conversion chart.
Intravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs.
the following data will be recorded Complications: hematoma, nausea, vomiting, itching, urine retention, constipation, Initial pathology, type and length of skin incision, duration of surgery, blood loss, need for blood transfusion, vasoactive drugs Age, sex, American society of anesthesiologist-physical status (ASA), comorbidity, weight, height and body mass index
- Conditions
- Analgesia, Hepatic Resection Surgery
- Being tested
- subcostal transversus plane block, erector spinae plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcostal transversus plane blockOther
Patient in TAP block group will receive oblique subcostal TAP while in supine position using a linear 6-13 MHz ultrasound transducer. The operator will place the ultrasound probe obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The landmarks, which included the rectus abdominis muscle and underlying transversus abdominis muscle, will be identified near the costal margin and xyphoid. The probe will be then moved laterally until the aponeurosis of the external, internal oblique, and transversus abdominis are seen, and then the probe will be moved further laterally until the transversus abdominis muscle is identified. The operator will direct the needle toward the transversus abdominis, and the local anesthetic solution will be injected after negative aspiration between the rectus abdominis and transversus abdominis muscles along the subcostal line (in-plane superomedial to inferolateral)
erector spinae plane blockOther
Patients in ESPB group will be turned to the lateral position and receive ESPB at the level of the 7th thoracic (T7) transverse process using a linear 6-13 MHz ultrasound transducer. The transducer will be positioned vertically 3 cm to the side of the midline to visualize the muscles of the back, the transverse process, and the pleura between the two transverse processes. Then, a 22G 10-mm needle will be introduced in the cranial-caudal direction toward the transverse process (T7) using the in-plane method till the needle tip crosses all the muscles. The tip of needle should be in the plane between the transverse process and the erector spinae muscle. After ensuring negative aspiration, the local anesthetic solution will be injected below the muscle. the procedure will be repeated on the other side
| Study group | Role | What they receive |
|---|---|---|
| subcostal transversus abdominis plane block group | Active comparator | subcostal transversus abdominis plane block Receives: Other: subcostal transversus plane block |
| erector spinae plane block group | Active comparator | erector spinae plane block Receives: Other: erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine requirement in the first 24 hours
mg
Measured: 0.5 hour after extubation till 24 hour after extubation
Secondary outcomes (7)
intraoperative morphine requirement
mg
Measured: 15 minutes after block administration till 1 minutes after extubation
time to first morphine requirement
hours
Measured: 1 minute after block administration till 24 hours postoperatively
NRS
11-points scale in which the patients are asked to circle the number between 0 and 10 that best describe their pain intensity. Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible
Measured: 0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room
Time to independent movement
time in hours of being able to be independently mobile e.g. using the bathroom
Measured: 0.5 hour after extubation till 24 hour after extubation
heart rate
beat per minutes
Measured: 15 minutes before induction of anesthesia, 15 minutes after induction of anesthesia, every 15 minutes intraoperatively and 0.5, 1, 2, 4, 6, 18, 24 hours postoperatively
mean arterial pressure
mmHg
Measured: 15 minutes before induction of anesthesia, 15 minutes after induction of anesthesia, every 15 minutes intraoperatively and 0.5, 1, 2, 4, 6, 18, 24 hours postoperatively
Modified Ramsay Sedation Score
1 = Awake and alert 2 = Slightly sedated, 3 = moderately sedated follows simple commands, 4 = deeply sedated, responds to nonpainful stimuli, 5 = deeply sedated, responds to painful stimuli, 6 = deeply sedated, unresponsive to painful stimuli
Measured: 0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Mar 2022
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (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 AnalgesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253079
- Sponsor's protocol ID
- MS-481-2021
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data can be available from the principle investigator upon reasonable request
Publications
Mostafa M, Mousa MS, Hasanin A, Arafa AS, Raafat H, Ragab AS. Erector spinae plane block versus subcostal transversus abdominis plane block in patients undergoing open liver resection surgery: A randomized controlled trial. Anaesth Crit Care Pain Med. 2023 Feb;42(1):101161. doi: 10.1016/j.accpm.2022.101161. Epub 2022 Sep 22.
PubMed 36154912
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Patients Undergoing Open Liver Resection Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05253079
- Acronym / sponsor ID
- MS-481-2021
- Conditions
- Analgesia, Hepatic Resection Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 23 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.
Liver resection surgery is a common surgical procedure which is performed on patients with benign, malignant or metastatic hepatic tumor as well as for living liver donor. Liver resection surgery is usually performed through either right subcostal or inversed L-shaped incision; both approaches are associated with a significant postoperative pain which requires intensive analgesic plan to facilitate early mobilization and minimize complications.
There are various lines for pain management in liver resection surgery such as systemic analgesic drugs, neuraxial blocks (e.g., thoracic epidural analgesia) and transversus abdominis plane [TAP] block).
Systemic analgesic drugs are nearly constantly used in liver resection. However, being systemically administered, these drugs have many side effects on many organs and cannot totally eliminate postoperative pain. Thoracic epidural block is commonly associated with hypotension; furthermore, its use has other limitations such as delaying postoperative mobilization and possible hematoma and cord compression in patients with coagulopathy which is expected following liver resection. Therefore, there had been an increased interest in the use of abdominal field blocks to avoid disadvantages of neuraxial blocks and minimize the use of parenteral analgesic drugs.
TAP block is one of the classic field blocks which is extensively used in laparotomies including liver resection. However, the lack of visceral pain control TAP block influences the quality of its analgesic effect in this type of patients. Nevertheless, TAP block, namely the subcostal approach, is still the recommended field block in the latest procedure-specific recommendations for pain management in liver resection as it is the only block which showed good evidence.
In recent years, there has been increased interest in a newer field block, the erector spinae plane block (ESPB), due its easy performance and the possible coverage of visceral pain in addition to the somatic pain. ESPB showed promising results in liver resection surgery. ESBP was superior to TAP block in various abdominal surgeries. However, its analgesic efficacy had not been previously compared in relation to TAP in patients undergoing open liver resection surgery.
Detailed description
An independent research assistant will be responsible for opening the envelope and drug preparation with no further involvement in the study. The local anesthetic solution preparation will be as follow; 2 syringes of 20 ml of 0.25% isobaric bupivacaine.
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and pre-medication drugs will be delivered (metoclopramide 10 mg, and omeprazole 40 mg).
General anesthesia will be induced by 2-3 mg/kg propofol and 1-2 mcg/kg fentanyl. Tracheal intubation by direct laryngoscopy will be facilitated by atracurium 0.5 mg/kg. Anesthesia will be maintained by 2-2.5% sevoflurane and 0.1 mg/kg/20min atracurium.
After induction of anesthesia, patients will receive their assigned intervention.
Intraoperative analgesic management Morphine boluses (titrated 0.05 mg/kg boluses till response) will be given in case of inadequate analgesia (heart rate/mean blood pressure increase by 20% from the baseline) Intraoperative fluid and hemodynamic management will be according to the discretion of the attending anesthetist.
At the end of the surgery, all patients will receive intravenous paracetamol (1 g) and ketorolac (30 mg) before the extubation.
Postoperative care All patients will receive regular intravenous paracetamol 1 g/6hours and ketorolac 30 mg/8hours. Pain assessments using Numerical Rating Scale (NRS) will be performed at rest and during cough at 0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room. If NRS score is > 3 intravenous titration of 2 mg morphine is given slowly to be repeated after 30 minutes if pain persisted. If other opioids are given, morphine equivalent dose will be calculated using opioids conversion chart.
Intravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs.
the following data will be recorded Complications: hematoma, nausea, vomiting, itching, urine retention, constipation, Initial pathology, type and length of skin incision, duration of surgery, blood loss, need for blood transfusion, vasoactive drugs Age, sex, American society of anesthesiologist-physical status (ASA), comorbidity, weight, height and body mass index
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subcostal transversus abdominis plane block group | Active comparator | Other: subcostal transversus plane blocksubcostal transversus abdominis plane block |
| erector spinae plane block group | Active comparator | Other: erector spinae plane blockerector spinae plane block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients (>18 years),
- ASA-physical status I-III
- undergoing open liver resection surgery for either primary/metastatic hepatic malignancy, biliary tract malignancy, or benign hepatic tumor
Key exclusion criteria (10 listed)
- history of allergy to any of the study drugs,
- a body mass index (BMI) <18 or ≥ 35 kg/m2,
- coagulopathy (INR >1.5 and/or platelet count <70000/µL),
- local infection,
- history of chronic pain or regular opioid use;
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 |
|---|---|---|
| subcostal transversus plane blockPatient in TAP block group will receive oblique subcostal TAP while in supine position using a linear 6-13 MHz ultrasound transducer. The operator will place the ultrasound probe obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The landmarks, which included the rectus abdominis muscle and underlying transversus abdominis muscle, will be identified near the costal margin and xyphoid. The probe will be then moved laterally until the aponeurosis of the external, internal oblique, and transversus abdominis are seen, and then the probe will be moved further laterally until the transversus abdominis muscle is identified. The operator will direct the needle toward the transversus abdominis, and the local anesthetic solution will be injected after negative aspiration between the rectus abdominis and transversus abdominis muscles along the subcostal line (in-plane superomedial to inferolateral) | Other | subcostal transversus abdominis plane block group |
| erector spinae plane blockPatients in ESPB group will be turned to the lateral position and receive ESPB at the level of the 7th thoracic (T7) transverse process using a linear 6-13 MHz ultrasound transducer. The transducer will be positioned vertically 3 cm to the side of the midline to visualize the muscles of the back, the transverse process, and the pleura between the two transverse processes. Then, a 22G 10-mm needle will be introduced in the cranial-caudal direction toward the transverse process (T7) using the in-plane method till the needle tip crosses all the muscles. The tip of needle should be in the plane between the transverse process and the erector spinae muscle. After ensuring negative aspiration, the local anesthetic solution will be injected below the muscle. the procedure will be repeated on the other side | Other | erector spinae plane block group |
Primary outcome
total morphine requirement in the first 24 hours
Time frame: 0.5 hour after extubation till 24 hour after extubation
mg
7 secondary outcomes
intraoperative morphine requirement
Time frame: 15 minutes after block administration till 1 minutes after extubation
time to first morphine requirement
Time frame: 1 minute after block administration till 24 hours postoperatively
NRS
Time frame: 0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room
Time to independent movement
Time frame: 0.5 hour after extubation till 24 hour after extubation
heart rate
Time frame: 15 minutes before induction of anesthesia, 15 minutes after induction of anesthesia, every 15 minutes intraoperatively and 0.5, 1, 2, 4, 6, 18, 24 hours postoperatively
mean arterial pressure
Time frame: 15 minutes before induction of anesthesia, 15 minutes after induction of anesthesia, every 15 minutes intraoperatively and 0.5, 1, 2, 4, 6, 18, 24 hours postoperatively
Modified Ramsay Sedation Score
Time frame: 0.5, 1, 2, 4, 6, 18, 24 hours after leaving the operating room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 36154912Mostafa M, Mousa MS, Hasanin A, Arafa AS, Raafat H, Ragab AS. Erector spinae plane block versus subcostal transversus abdominis plane block in patients undergoing open liver resection surgery: A randomized controlled trial. Anaesth Crit Care Pain Med. 2023 Feb;42(1):101161. doi: 10.1016/j.accpm.2022.101161. Epub 2022 Sep 22.
- Individual participant dataSharing planned: No. data can be available from the principle investigator upon reasonable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcostal transversus plane block and erector spinae plane block in people with Analgesia and Hepatic Resection Surgery, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 inclusion and 10 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 11 Mar 2022. 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 Egypt. 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?
Contact ahmed hasanin (01095076954, ahmedmohamedhasanin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total morphine requirement in the first 24 hours (time frame: 0.5 hour after extubation till 24 hour after extubation). 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 NCT05253079, 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 11 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.