Pain, PostoperativeNCT06448299
Erector Spinae Plane Block Versus Oblique-Subcostal Transversus Abdominis Plane Block in Emergency Abdominal Surgery with Midline Incision
A study testing TAPB and ESPB in people with Pain, Postoperative and Abdominal Surgery, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Most of the recommendations regarding pain management in emergency abdominal surgery are extracted from data from elective abdominal surgery. However, surgery in the emergency settings differs from the elective settings in the extent stress and the pain which is usually present preoperatively; therefore, it is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Abdominal Surgery, Emergency
- What is being tested?
- TAPB and ESPB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2024to 8 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (>18 years), undergoing emergency abdominal surgery with midline incision
Who cannot join
- American society of anesthesiologist-physical status >III,
- patients with a history of allergy to any of the study drugs,
- a body mass index (BMI) <18 or ≥ 40 kg/m2,
- coagulopathy
- local infection,
- history of chronic pain or regular opioid use;
Show all 10Show fewer
- inability to comprehend the Numeric Rating Scale (NRS),
- pregnant or lactating women. Patients on vasopressor infusion,
- patients with high shock index (heart rate / systolic blood pressure >1)
- patients requiring postoperative mechanical ventilation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Versus Oblique-Subcostal Transversus Abdominis Plane Block in Patients Undergoing Emergency Abdominal Surgery with Midline Incision: a Randomized Controlled Trial
Most of the recommendations regarding pain management in emergency abdominal surgery are extracted from data from elective abdominal surgery. However, surgery in the emergency settings differs from the elective settings in the extent stress and the pain which is usually present preoperatively; therefore, it is expected to have different analgesic requirements and different response to pain management interventions in emergency surgery.
Abdominal wall blocks are increasingly used in abdominal surgery. However, data regarding their efficacy in emergency setting are lacking. Oblique-subcostal transversus abdominis plane block (OS-TAPB) is a variation of the subcostal TAPB that could achieve effective analgesia for both upper and lower parts of the abdomen. The TAPB characterized by being easy to perform and does not require patient repositioning. Erector spinae plane block (ESPB) is another abdominal wall block that showed good analgesic effect following various elective open abdominal surgeries, but the block requires patient repositioning before block performance. In elective abdominal surgeries, the current evidence slightly supports ESPB over the TAPB. We hypothesize that the difference between the two blocks would be more apparent in in emergency surgery due to the type of incision, extent of tissue manipulation, and severity of pain.
Read the detailed description
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 mg/kg propofol and 1 mcg/kg fentanyl. After loss of consciousness, tracheal intubation by direct laryngoscopy will be facilitated by 1 mg/kg succinyl choline. Anesthesia will be maintained by 1-1.2% isoflurane and atracurium will be administered after patient recovery from succinylcholine at a dose of 0.5 mg/Kg. Atracurium increments of 0.1 mg/kg will be administered every 20 min for maintenance of neuromuscular blockade.
After induction of anesthesia, patients will receive the block according to the group assignment In both blocks a total of 25 mL of 0.25% bupivacaine will be administered in each side.
The blocks will be performed by an experienced operator who will be informed of the patient group after induction of anesthesia. The patient, surgeon and data collector will be blinded to the study group.
Intraoperative analgesic management Fentanyl boluses of 1 mcg/kg will be given in case of inadequate analgesia (heart rate/mean blood pressure increase by 20% from the baseline in absence of other causes) 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 acetaminophen (1 g) before the extubation.
Postoperative care All patients will receive regular intravenous acetaminophen 1 g/6 hours. Pain assessments using NRS will be performed at rest and during cough at 0.5, 1, 4, 8, 12, 24 h after leaving the operating room. If NRS score is > 3 (at any time not limited to the time of assessment) intravenous titration of 3 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
- Conditions
- Pain, Postoperative, Abdominal Surgery, Emergency
- Being tested
- TAPB, ESPB
- Medical subject headings
- Pain, Postoperative, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPBProcedure or surgery
Patients will receive ultrasound guided bilateral oblique subcostal TAPB using 25 mL bupivacaine 0.25% in each side
ESPBBiological
Patients will receive ultrasound guided bilateral ESPB at T8 level using 25 mL bupivacaine 0.25% in each side
| Study group | Role | What they receive |
|---|---|---|
| TAPB | Active comparator | Not described Receives: Procedure: TAPB |
| ESPB | Active comparator | Not described Receives: Biological: ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine consumption
mg
Measured: 30 minutes postoperatively till 24 hours postoperatively
Secondary outcomes (6)
numerical rating scale at rest
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) will be performed at rest and during cough at 0.5, 1, 4, 8, 12, 24 h after leaving the operating room
Measured: 30 minutes postoperatively till 24 hours postoperatively
numerical rating scale during cough
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) will be performed at rest and during cough at 0.5, 1, 4, 8, 12, 24 h after leaving the operating room
Measured: 30 minutes postoperatively till 24 hours postoperatively
Time to first morphine requirement
hours
Measured: 30 minutes postoperatively till 24 hours postoperatively
Time to independent movement
hours
Measured: 30 minutes postoperatively till 24 hours postoperatively
postoperative sedation
modified Ramsay Sedation score
Measured: 30 minutes postoperatively till 24 hours postoperatively
patients satisfaction
using the NRS 0= worst experience, 10= best experience.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start20 Jun 2024
- Primary completion6 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 70 participants (actual)
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
- NCT06448299
- Sponsor's protocol ID
- MD-305-2023
- Status last verified
- Dec 2024
- First submitted
- 3 Jun 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data related to this study will be provided from the PI upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Oblique-Subcostal Transversus Abdominis Plane Block in Patients Undergoing Emergency Abdominal Surgery with Midline Incision: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06448299
- Acronym / sponsor ID
- MD-305-2023
- Conditions
- Pain, Postoperative, Abdominal Surgery, Emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 7 Jun 2024 (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.
Most of the recommendations regarding pain management in emergency abdominal surgery are extracted from data from elective abdominal surgery. However, surgery in the emergency settings differs from the elective settings in the extent stress and the pain which is usually present preoperatively; therefore, it is expected to have different analgesic requirements and different response to pain management interventions in emergency surgery.
Abdominal wall blocks are increasingly used in abdominal surgery. However, data regarding their efficacy in emergency setting are lacking. Oblique-subcostal transversus abdominis plane block (OS-TAPB) is a variation of the subcostal TAPB that could achieve effective analgesia for both upper and lower parts of the abdomen. The TAPB characterized by being easy to perform and does not require patient repositioning. Erector spinae plane block (ESPB) is another abdominal wall block that showed good analgesic effect following various elective open abdominal surgeries, but the block requires patient repositioning before block performance. In elective abdominal surgeries, the current evidence slightly supports ESPB over the TAPB. We hypothesize that the difference between the two blocks would be more apparent in in emergency surgery due to the type of incision, extent of tissue manipulation, and severity of pain.
Detailed description
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 mg/kg propofol and 1 mcg/kg fentanyl. After loss of consciousness, tracheal intubation by direct laryngoscopy will be facilitated by 1 mg/kg succinyl choline. Anesthesia will be maintained by 1-1.2% isoflurane and atracurium will be administered after patient recovery from succinylcholine at a dose of 0.5 mg/Kg. Atracurium increments of 0.1 mg/kg will be administered every 20 min for maintenance of neuromuscular blockade.
After induction of anesthesia, patients will receive the block according to the group assignment In both blocks a total of 25 mL of 0.25% bupivacaine will be administered in each side.
The blocks will be performed by an experienced operator who will be informed of the patient group after induction of anesthesia. The patient, surgeon and data collector will be blinded to the study group.
Intraoperative analgesic management Fentanyl boluses of 1 mcg/kg will be given in case of inadequate analgesia (heart rate/mean blood pressure increase by 20% from the baseline in absence of other causes) 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 acetaminophen (1 g) before the extubation.
Postoperative care All patients will receive regular intravenous acetaminophen 1 g/6 hours. Pain assessments using NRS will be performed at rest and during cough at 0.5, 1, 4, 8, 12, 24 h after leaving the operating room. If NRS score is > 3 (at any time not limited to the time of assessment) intravenous titration of 3 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
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 |
|---|---|---|
| TAPB | Active comparator | Procedure: TAPB |
| ESPB | Active comparator | Biological: ESPB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients (>18 years), undergoing emergency abdominal surgery with midline incision
Key exclusion criteria (10 listed)
- American society of anesthesiologist-physical status >III,
- patients with a history of allergy to any of the study drugs,
- a body mass index (BMI) <18 or ≥ 40 kg/m2,
- coagulopathy
- local infection,
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 |
|---|---|---|
| TAPBPatients will receive ultrasound guided bilateral oblique subcostal TAPB using 25 mL bupivacaine 0.25% in each side | Procedure or surgery | TAPB |
| ESPBPatients will receive ultrasound guided bilateral ESPB at T8 level using 25 mL bupivacaine 0.25% in each side | Biological | ESPB |
Primary outcome
postoperative morphine consumption
Time frame: 30 minutes postoperatively till 24 hours postoperatively
mg
6 secondary outcomes
numerical rating scale at rest
Time frame: 30 minutes postoperatively till 24 hours postoperatively
numerical rating scale during cough
Time frame: 30 minutes postoperatively till 24 hours postoperatively
Time to first morphine requirement
Time frame: 30 minutes postoperatively till 24 hours postoperatively
Time to independent movement
Time frame: 30 minutes postoperatively till 24 hours postoperatively
postoperative sedation
Time frame: 30 minutes postoperatively till 24 hours postoperatively
patients satisfaction
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. data related to this study will be provided from the PI 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAPB and ESPB in people with Pain, Postoperative and Abdominal 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 1 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: finished, as of the sponsor's last update on 27 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative morphine consumption (time frame: 30 minutes postoperatively till 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 27 Dec 2024.