Transversalis Fascia Plane BlockNCT07201272
Transversalis Fascia Plane Block Versus Intrathecal Morphine for Postoperative Analgesia in Total Abdominal Hysterectomy
A study testing Transversalis fascia plane block and Morphine in people with Transversalis Fascia Plane Block and Intrathecal Morphine, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the ultrasound-guided transversalis fascia plane (TFP) block and intrathecal morphine for postoperative analgesia in patients undergoing total abdominal hysterectomy (TAH). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transversalis Fascia Plane Block, Intrathecal Morphine, Postoperative Analgesia
- What is being tested?
- Transversalis fascia plane block and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 11 Apr 2026
- 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
- Age from 18 to 65 years.
- American Society of Anesthesiology (ASA) physical status I-II.
- Women undergoing total abdominal hysterectomy (TAH) under spinal anesthesia.
Who cannot join
- History of allergies to local anesthetics.
- Local infection at the site of injection.
- Bleeding disorders.
- History of chronic use of analgesic.
- Physical or mental conditions.
- Hepatic, renal or cardiac disease.
- Contraindication to spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Transversalis Fascia Plane Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Clinical Trial
This study aims to compare the ultrasound-guided transversalis fascia plane (TFP) block and intrathecal morphine for postoperative analgesia in patients undergoing total abdominal hysterectomy (TAH).
Read the detailed description
Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort. Postoperative pain, if not treated promptly, can impair the patient's ability to ambulate which may lead to adverse effects such as thromboembolism, myocardial ischemia, and arrhythmia.
Intrathecal opioids are synergistic with local anesthetics and intensify the sensory block without increasing the sympathetic block. Morphine, which is relatively less hydrophobic than other opioids, has a longer residence time in the cerebrospinal fluid and therefore may reach rostral sites over a longer period than other opioids.
Ultrasound-guided interfascial plane blocks are often used in multimodal analgesia regimens. Local anaesthetic injection into the transversalis fascia plane (TFP) anesthetizes the proximal branches of T12 and L1 which targeted in the plane between the transversus abdominis muscle and the transversalis fascia.
- Conditions
- Transversalis Fascia Plane Block, Intrathecal Morphine, Postoperative Analgesia, Total Abdominal Hysterectomy
- Being tested
- Transversalis fascia plane block, Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis fascia plane blockOther
Patients will receive spinal anesthesia (using 3.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.
MorphineDrug
Patients will receive spinal anesthesia (using 3 mL of hyperbaric bupivacaine 0.5%) + (75 µg morphine diluted in 0.5ml saline) with sham block at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| TFP group | Experimental | Patients will receive spinal anesthesia (using 3.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery. Receives: Other: Transversalis fascia plane block |
| IM group | Experimental | Patients will receive spinal anesthesia (using 3 mL of hyperbaric bupivacaine 0.5%) + (75 µg morphine diluted in 0.5ml saline) with sham block at the end of surgery. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).
Measured: 24 hours postoperatively
Secondary outcomes (3)
Total morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS)> 3 to be repeated after 30 min if pain persists until the NRS < 4.
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 8, 12, 18, and 24 h postoperatively.
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, pruritis, nausea, vomiting, respiratory depression, or any other complication will be recorded.
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 posted1 Oct 2025
- Study start1 Oct 2025
- Primary completion11 Apr 2026
- Study completion11 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transversalis Fascia Plane BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201272
- Sponsor's protocol ID
- 36264PR1337/8/25
- Status last verified
- Apr 2026
- First submitted
- 23 Sep 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Transversalis Fascia Plane Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07201272
- Acronym / sponsor ID
- 36264PR1337/8/25
- Conditions
- Transversalis Fascia Plane Block, Intrathecal Morphine, Postoperative Analgesia, Total Abdominal Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 11 Apr 2026 (actual)
- Study completion
- 11 Apr 2026 (actual)
- First posted
- 1 Oct 2025 (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.
This study aims to compare the ultrasound-guided transversalis fascia plane (TFP) block and intrathecal morphine for postoperative analgesia in patients undergoing total abdominal hysterectomy (TAH).
Detailed description
Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort. Postoperative pain, if not treated promptly, can impair the patient's ability to ambulate which may lead to adverse effects such as thromboembolism, myocardial ischemia, and arrhythmia.
Intrathecal opioids are synergistic with local anesthetics and intensify the sensory block without increasing the sympathetic block. Morphine, which is relatively less hydrophobic than other opioids, has a longer residence time in the cerebrospinal fluid and therefore may reach rostral sites over a longer period than other opioids.
Ultrasound-guided interfascial plane blocks are often used in multimodal analgesia regimens. Local anaesthetic injection into the transversalis fascia plane (TFP) anesthetizes the proximal branches of T12 and L1 which targeted in the plane between the transversus abdominis muscle and the transversalis fascia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TFP group | Experimental | Other: Transversalis fascia plane blockPatients will receive spinal anesthesia (using 3.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery. |
| IM group | Experimental | Drug: MorphinePatients will receive spinal anesthesia (using 3 mL of hyperbaric bupivacaine 0.5%) + (75 µg morphine diluted in 0.5ml saline) with sham block at the end of surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18 to 65 years.
- American Society of Anesthesiology (ASA) physical status I-II.
- Women undergoing total abdominal hysterectomy (TAH) under spinal anesthesia.
Key exclusion criteria (7 listed)
- History of allergies to local anesthetics.
- Local infection at the site of injection.
- Bleeding disorders.
- History of chronic use of analgesic.
- Physical or mental conditions.
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 |
|---|---|---|
| Transversalis fascia plane blockPatients will receive spinal anesthesia (using 3.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery. | Other | TFP group |
| MorphinePatients will receive spinal anesthesia (using 3 mL of hyperbaric bupivacaine 0.5%) + (75 µg morphine diluted in 0.5ml saline) with sham block at the end of surgery. | Drug | IM group |
Primary outcome
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).
3 secondary outcomes
Total morphine consumption
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Incidence of adverse events
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 22 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Transversalis Fascia Plane Block
Not yet recruiting
PQLB vs TFPB in HALDN
Analgesia, Donor Nephrectomy
Not yet recruitingObservational study
Comparison of Quadro-Iliac Plane Block and Transversalis Fascia Plane Block for Open Inguinal Hernia Repair
Inguinal Hernia Unilateral
Recruiting
Intrathecal Morphine and Transversalis Fascia Plane Block for Analgesia After Open Inguinal Hernia Repair
Pain, Postoperative, Inguinal Hernia Unilateral
Recruiting
Transversalis Fascia Plane Block Versus Low-Dose Intrathecal Morphine for Open Inguinal Hernia Repair
Postoperative Pain
Recruiting
Analgesic Efficacy of Quadratus Lumborum vs. Transversalis Fascia Block in Inguinal Hernia Surgery
Pain, Postoperative
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 Transversalis fascia plane block and Morphine in people with Transversalis Fascia Plane Block and Intrathecal Morphine, run by Tanta 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 3 inclusion and 7 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 22 Apr 2026. 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?
Time to the 1st rescue analgesia (time frame: 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 22 Apr 2026.