Postoperative Analgesia of Inguinal Hernia Repair in AdultsNCT06219837
Subarachnoid Block Versus Ultrasound Guided Transversalis Fascia Plane Block for Postoperative Analgesia of Inguinal Hernia Repair in Adults
A study testing bupivacaine injection by ultrasound guided transversalis fascia plane block in people with Postoperative Analgesia of Inguinal Hernia Repair in Adults, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of our study is to investigate the effect of the ultrasound guided transversalis fascia plane block on the postoperative opioid consumption as a part of multimodal analgesia in patients undergoing inguinal herniorrhaphy under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Analgesia of Inguinal Hernia Repair in Adults
- What is being tested?
- bupivacaine injection by ultrasound guided transversalis fascia plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing inguinal herniorrhaphy.
- Patients 18-60 years.
- ASA I and II.
- Both sexes.
- Having no contraindication for spinal anesthesia or TFP block.
Who cannot join
- Refusal of regional anesthesia.
- Infection in the back or at the site of injection for TFP block.
- INR > 1.5.
- Platelet count < 80000 per microliter of blood.
- Patients known to be allergic to amide local anesthetics.
- BMI greater than 35 kgm_2.
- Opioid addiction.
- Have communication problems that may hinder the assessement of pain postoperative.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo, Giza Governorate, 11111
Rabab Sabry, MD, 0101079 2931, rababsabry@hotmail.com
Omnia Kamel, MD, 01270 130326, omniayehiakamel90@gmail.com
About this study
Official title: Subarachnoid Block Versus Ultrasound Guided Transversalis Fascia Plane Block for Postoperative Analgesia of Inguinal Hernia Repair in Adults: A Randomized, Double Blinded, Controlled Trial
The aim of our study is to investigate the effect of the ultrasound guided transversalis fascia plane block on the postoperative opioid consumption as a part of multimodal analgesia in patients undergoing inguinal herniorrhaphy under spinal anesthesia.
Read the detailed description
The aim of our study is to investigate the efficacy of the ultrasound-guided transversalis fascia plane block as a postoperative analgesia as a part of multimodal analgesia in patients undergoing inguinal herniorrhaphy under spinal anesthesia.
The ultrasound (US)-guided transversalis fascia plane (TFP) block was first described by Hebbard in 2009. A local anesthetic (LA) injected between the transversus abdominis muscle, and its deep investing fascia will block the anterior and the lateral branches of the T12 and L1 nerves (4). The efficacy of this block has been demonstrated in iliac crest bone graft harvesting, caesarean section and inguinal herniorrhaphy
- Being tested
- bupivacaine injection by ultrasound guided transversalis fascia plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine injection by ultrasound guided transversalis fascia plane blockDrug
Also called 20 ml of 0.9% normal saline solution
With patients in a sitting position and after appropriate skin asepsis, a 25-G pencil-point spinal needle (Pencil Point Spinal Needle Set, Egemen International Ltd., Izmir, Turkey) will be inserted through the L3 to L4 or L4 to L5 intervertebral space and 15 mg of 0.5% hyperbaric bupivacaine (AstraZeneca Pharmaceuticals, Cambridge, United Kingdom) will be injected. Subsequently, the patients will be positioned supine.
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine group | Active comparator | the patient in this arm will receive 20 ml of 0.25% bupivacaine injection by ultrasound guided transversalis fascia block for inguinal herniorraphy Receives: Drug: bupivacaine injection by ultrasound guided transversalis fascia plane block |
| 20 ml of 0.9% normal saline solution | Placebo comparator | he patient in this arm will receive 20 ml of 0.9% normal saline solution by ultrasound guided transversalis fascia block for inguinal herniorraphy Receives: Drug: bupivacaine injection by ultrasound guided transversalis fascia plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of postoperative morphine consumption during the first 24hrs postoperative.
The patients will be evaluated regarding the first demand to rescue analgesia postoperatively. The pain will be assessed by the VAS score. It will be performed in the immediate post-operative period every 15 min for the first 60 min, 2 h, 4 h, 8h, 12h, 18 and 24 h. Breakthrough pain will be defined as VAS >4 at rest.
Measured: First 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Aug 2023
- Primary completionAug 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Analgesia of Inguinal Hernia Repair in AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab, Cairo University
- Investigators
- Marwa Zayed, Assistant professor, Study director, Cairo UniversityBelal Khater, Master, Principal investigator, Cairo UniversityMohamed Mohamed, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219837
- Sponsor's protocol ID
- (TFP) block
- Status last verified
- Jan 2024
- First submitted
- 6 Jun 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subarachnoid Block Versus Ultrasound Guided Transversalis Fascia Plane Block for Postoperative Analgesia of Inguinal Hernia Repair in Adults: A Randomized, Double Blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT06219837
- Acronym / sponsor ID
- (TFP) block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 23 Jan 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 our study is to investigate the effect of the ultrasound guided transversalis fascia plane block on the postoperative opioid consumption as a part of multimodal analgesia in patients undergoing inguinal herniorrhaphy under spinal anesthesia.
Detailed description
The aim of our study is to investigate the efficacy of the ultrasound-guided transversalis fascia plane block as a postoperative analgesia as a part of multimodal analgesia in patients undergoing inguinal herniorrhaphy under spinal anesthesia.
The ultrasound (US)-guided transversalis fascia plane (TFP) block was first described by Hebbard in 2009. A local anesthetic (LA) injected between the transversus abdominis muscle, and its deep investing fascia will block the anterior and the lateral branches of the T12 and L1 nerves (4). The efficacy of this block has been demonstrated in iliac crest bone graft harvesting, caesarean section and inguinal herniorrhaphy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine group | Active comparator | Drug: bupivacaine injection by ultrasound guided transversalis fascia plane blockthe patient in this arm will receive 20 ml of 0.25% bupivacaine injection by ultrasound guided transversalis fascia block for inguinal herniorraphy |
| 20 ml of 0.9% normal saline solution | Placebo comparator | Drug: bupivacaine injection by ultrasound guided transversalis fascia plane blockhe patient in this arm will receive 20 ml of 0.9% normal saline solution by ultrasound guided transversalis fascia block for inguinal herniorraphy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing inguinal herniorrhaphy.
- Patients 18-60 years.
- ASA I and II.
- Both sexes.
- Having no contraindication for spinal anesthesia or TFP block.
Key exclusion criteria (8 listed)
- Refusal of regional anesthesia.
- Infection in the back or at the site of injection for TFP block.
- INR > 1.5.
- Platelet count < 80000 per microliter of blood.
- Patients known to be allergic to amide local anesthetics.
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 |
|---|---|---|
| bupivacaine injection by ultrasound guided transversalis fascia plane blockAlso: 20 ml of 0.9% normal saline solutionWith patients in a sitting position and after appropriate skin asepsis, a 25-G pencil-point spinal needle (Pencil Point Spinal Needle Set, Egemen International Ltd., Izmir, Turkey) will be inserted through the L3 to L4 or L4 to L5 intervertebral space and 15 mg of 0.5% hyperbaric bupivacaine (AstraZeneca Pharmaceuticals, Cambridge, United Kingdom) will be injected. Subsequently, the patients will be positioned supine. | Drug | 20 ml of 0.9% normal saline solution, bupivacaine group |
Primary outcome
The total amount of postoperative morphine consumption during the first 24hrs postoperative.
Time frame: First 24 hours postoperative
The patients will be evaluated regarding the first demand to rescue analgesia postoperatively. The pain will be assessed by the VAS score. It will be performed in the immediate post-operative period every 15 min for the first 60 min, 2 h, 4 h, 8h, 12h, 18 and 24 h. Breakthrough pain will be defined as VAS >4 at rest.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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Postoperative Analgesia of Inguinal Hernia Repair in Adults
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.
Marwa Zayed, Assistant professor study director
Cairo University
Belal Khater, Master principal investigator
Cairo University
Mohamed Mohamed, MD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine injection by ultrasound guided transversalis fascia plane block in people with Postoperative Analgesia of Inguinal Hernia Repair in Adults, 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 5 inclusion and 8 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 23 Jan 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. Some participants in this study may receive a placebo. 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 Rabab Sabry, MD (01010792931, rababsabry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total amount of postoperative morphine consumption during the first 24hrs postoperative. (time frame: First 24 hours postoperative). 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 23 Jan 2024; AzTrials last refreshed its copy on 26 Oct 2026.