Pain, PostoperativeNCT06564610
Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Bariatric Surgery
A study testing Transversus abdominis block, Erector spinae block and Bariatric surgery in people with Pain, Postoperative and Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this work is to compare the analgesic efficacy of laparoscopic transversus abdominis plane block, performed by the surgeon to ultrasound-guided erector spinae plane block, performed by the anesthetist, in patients with obesity undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Obesity, Analgesia
- What is being tested?
- Transversus abdominis block, Erector spinae block and Bariatric surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2024to 9 Jan 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with obesity undergoing laparoscopic bariatric surgery under general anesthesia.
Who cannot join
- Allergy to local anaesthetic.
- Bleeding disorders.
- Obstructive sleep apnea.
- inability to understand the numerical rating scale for pain assessment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine, Cairo University.
Cairo, Cairo Governorate, 11432
About this study
Official title: Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial
The aim of this work is to compare the analgesic efficacy of laparoscopic transversus abdominis plane block, performed by the surgeon to ultrasound-guided erector spinae plane block, performed by the anesthetist, in patients with obesity undergoing bariatric surgery.
Read the detailed description
This is a randomized controlled trial which will include patients with obesity undergoing bariatric surgery. The patients will be randomly allocated into two groups: transversus abdominis plane block group and erector spinae plane block group. The block will be performed after induction of general anesthesia. Preoperative evaluation and preparation will include history-taking, laboratory investigation, fasting recommendations, and optimization of the medical status. The two groups will receive standard induction and maintenance of anesthesia. After the end of the operation, patients will receive standard care according to the local protocols and the enhanced recovery recommendations. Patients will be monitored according to the pain-related outcomes as well as hemodynamic parameters.
- Conditions
- Pain, Postoperative, Obesity, Analgesia
- Being tested
- Transversus abdominis block, Erector spinae block, Bariatric surgery, Endotracheal intubation, Propofol
- Medical subject headings
- Pain, Postoperative, Obesity, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis blockProcedure or surgery
The block will be performed by the surgeon by injecting local anesthetic at the beginning of surgery under the guidance of the laparoscope.
Erector spinae blockProcedure or surgery
The block will be performed by the anesthetist by injecting local anesthetic after induction of anesthesia under the guidance of the ultrasound.
Bariatric surgeryProcedure or surgery
Laparoscopic bariatric procedure will be performed
Endotracheal intubationDevice
An endotracheal tube will be inserted as a part of general anesthesia to all patients
PropofolDrug
The patients will receive propofol for induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Transversus abdominis block | Experimental | Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery. Receives: Procedure: Transversus abdominis block; Procedure: Bariatric surgery; Device: Endotracheal intubation; Drug: Propofol |
| Erector spinae block | Active comparator | Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia. Receives: Procedure: Erector spinae block; Procedure: Bariatric surgery; Device: Endotracheal intubation; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
This is a scale for pain assessment which ranges between 0 and 10 with the highest level of pain having score 10 and lowest level of pain having score 0
Measured: 24 hours after surgery
Secondary outcomes (5)
Consumption of analgesia
This is the total consumption of nalbuphine by the patient measured in milligrams
Measured: 24 hours after surgery
Heart rate
This is the number of heart beats measured as frequency of heart beats in one minute.
Measured: 24 hours after surgery
Systolic blood pressure
This is the systolic arterial blood pressure measured in mmHg.
Measured: 24 hours after surgery
Vomiting
This is the incidence of vomiting after surgery measured as the frequency of patients with vomiting.
Measured: 24 hours
Diastolic blood pressure
This is the diastolic arterial blood pressure measured in mmHg.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start25 Aug 2024
- Primary completion5 Jan 2025
- Study completion9 Jan 2025
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.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Hasanin, Professor, Principal investigator, Professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564610
- Sponsor's protocol ID
- MD-292-2022
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06564610
- Acronym / sponsor ID
- MD-292-2022
- Conditions
- Pain, Postoperative, Obesity, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 21 Aug 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.
The aim of this work is to compare the analgesic efficacy of laparoscopic transversus abdominis plane block, performed by the surgeon to ultrasound-guided erector spinae plane block, performed by the anesthetist, in patients with obesity undergoing bariatric surgery.
Detailed description
This is a randomized controlled trial which will include patients with obesity undergoing bariatric surgery. The patients will be randomly allocated into two groups: transversus abdominis plane block group and erector spinae plane block group. The block will be performed after induction of general anesthesia. Preoperative evaluation and preparation will include history-taking, laboratory investigation, fasting recommendations, and optimization of the medical status. The two groups will receive standard induction and maintenance of anesthesia. After the end of the operation, patients will receive standard care according to the local protocols and the enhanced recovery recommendations. Patients will be monitored according to the pain-related outcomes as well as hemodynamic parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus abdominis block | Experimental | Procedure: Transversus abdominis block, Procedure: Bariatric surgery, Device: Endotracheal intubation, Drug: PropofolPatients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery. |
| Erector spinae block | Active comparator | Procedure: Erector spinae block, Procedure: Bariatric surgery, Device: Endotracheal intubation, Drug: PropofolPatients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with obesity undergoing laparoscopic bariatric surgery under general anesthesia.
Key exclusion criteria (4 listed)
- Allergy to local anaesthetic.
- Bleeding disorders.
- Obstructive sleep apnea.
- inability to understand the numerical rating scale for pain assessment.
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 |
|---|---|---|
| Transversus abdominis blockThe block will be performed by the surgeon by injecting local anesthetic at the beginning of surgery under the guidance of the laparoscope. | Procedure or surgery | Transversus abdominis block |
| Erector spinae blockThe block will be performed by the anesthetist by injecting local anesthetic after induction of anesthesia under the guidance of the ultrasound. | Procedure or surgery | Erector spinae block |
| Bariatric surgeryLaparoscopic bariatric procedure will be performed | Procedure or surgery | Erector spinae block, Transversus abdominis block |
| Endotracheal intubationAn endotracheal tube will be inserted as a part of general anesthesia to all patients | Device | Erector spinae block, Transversus abdominis block |
| PropofolThe patients will receive propofol for induction of anesthesia | Drug | Erector spinae block, Transversus abdominis block |
Primary outcome
Numerical rating scale
Time frame: 24 hours after surgery
This is a scale for pain assessment which ranges between 0 and 10 with the highest level of pain having score 10 and lowest level of pain having score 0
5 secondary outcomes
Consumption of analgesia
Time frame: 24 hours after surgery
Heart rate
Time frame: 24 hours after surgery
Systolic blood pressure
Time frame: 24 hours after surgery
Vomiting
Time frame: 24 hours
Diastolic blood pressure
Time frame: 24 hours
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 13 Jan 2025.
- 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.
Ahmed Hasanin, Professor principal investigator
Professor of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis block, Erector spinae block and Bariatric surgery in people with Pain, Postoperative and Obesity, run by Cairo University 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 4 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 13 Jan 2025. 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?
Numerical rating scale (time frame: 24 hours after surgery). 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 13 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.