Post-operative Pain ManagementPhase 1NCT06882369
TAP Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following TAH
A Phase 1 study testing TAP Block, Intrathecal morphine injection and spinal anesthesia in people with Post-operative Pain Management, run by Minia University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial designed to evaluate the efficacy of transversus abdominis plane (TAP) block, intrathecal morphine, or their combination in postoperative pain relief, as assessed by time to first analgesic request, pain scores, total postoperative analgesic consumption, time of ambulation… Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain Management
- What is being tested?
- TAP Block, Intrathecal morphine injection and spinal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to Jul 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients aged 30 to 70 years.
- Elective total abdominal hysterectomy.
- ASA physical status I or II.
- Willingness to provide informed consent.
Who cannot join
- Refusal of the block.
- Allergy to study medications.
- Preexisting coagulation disorders.
- Local infection at the site of needle insertion.
- Uncontrolled respiratory or cardiac disorders.
- Impaired kidney or liver function.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Minia University
Minya, Minya Governorate, 61111
About this study
Official title: Efficacy Of Transversus Abdominis Plane Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following Total Abdominal Hysterectomy.
This randomized controlled clinical trial designed to evaluate the efficacy of transversus abdominis plane (TAP) block, intrathecal morphine, or their combination in postoperative pain relief, as assessed by time to first analgesic request, pain scores, total postoperative analgesic consumption, time of ambulation, complications and hemodynamics following total abdominal hysterectomy.
- Conditions
- Post-operative Pain Management
- Being tested
- TAP Block, Intrathecal morphine injection, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP BlockProcedure or surgery
The transabdominal plane (TAP) block is a regional anesthesia technique used for postoperative pain management in abdominal wall procedures, providing somatic analgesia to the anterior and lateral abdominal walls
Intrathecal morphine injectionDrug
Intrathecal injection of morphine plus 20 mg hyperbaric bupivacaine in spinal anesthesia
spinal anesthesiaDrug
intrathecal injection of bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Active comparator | Bilateral ultrasound-guided TAP block with 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery. Receives: Procedure: TAP Block; Drug: spinal anesthesia |
| Intrathecal Morphine | Active comparator | Intrathecal injection of 100 µg morphine plus 20 mg hyperbaric bupivacaine (in spinal anesthesia). Receives: Drug: Intrathecal morphine injection; Drug: spinal anesthesia |
| Combined | Active comparator | Intrathecal injection of 50 µg morphine plus 20 mg hyperbaric bupivacaine combined with bilateral ultrasound-guided TAP block using 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery. Receives: Procedure: TAP Block; Drug: Intrathecal morphine injection; Drug: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic request
Time (in hours) until the patient demand additional analgesia.
Measured: 24 hours
Secondary outcomes (3)
Total analgesic consumption
Cumulative postoperative analgesic consumption
Measured: 24 hours
Time to ambulation
Time (in hours) from arrival in the PACU until the patient was able to walk.
Measured: 24 hours
complications
Incidence of nausea, vomiting, pruritus, respiratory depression, hematoma, infection or hemodynamic instability
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 posted18 Mar 2025
- Study start1 Nov 2024
- Primary completion1 Jun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Pain ManagementStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Ahmed Bakr Mohammed, Minia University
- Investigators
- sohair Adeeb, assist.prof., Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882369
- Sponsor's protocol ID
- TAP vs. morphine vs. both
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- 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 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Transversus Abdominis Plane Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following Total Abdominal Hysterectomy.
- ClinicalTrials.gov ID
- NCT06882369
- Acronym / sponsor ID
- TAP vs. morphine vs. both
- Conditions
- Post-operative Pain Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 18 Mar 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 randomized controlled clinical trial designed to evaluate the efficacy of transversus abdominis plane (TAP) block, intrathecal morphine, or their combination in postoperative pain relief, as assessed by time to first analgesic request, pain scores, total postoperative analgesic consumption, time of ambulation, complications and hemodynamics following total abdominal hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAP block | Active comparator | Procedure: TAP Block, Drug: spinal anesthesiaBilateral ultrasound-guided TAP block with 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery. |
| Intrathecal Morphine | Active comparator | Drug: Intrathecal morphine injection, Drug: spinal anesthesiaIntrathecal injection of 100 µg morphine plus 20 mg hyperbaric bupivacaine (in spinal anesthesia). |
| Combined | Active comparator | Procedure: TAP Block, Drug: Intrathecal morphine injection, Drug: spinal anesthesiaIntrathecal injection of 50 µg morphine plus 20 mg hyperbaric bupivacaine combined with bilateral ultrasound-guided TAP block using 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 30 to 70 years.
- Elective total abdominal hysterectomy.
- ASA physical status I or II.
- Willingness to provide informed consent.
Key exclusion criteria (6 listed)
- Refusal of the block.
- Allergy to study medications.
- Preexisting coagulation disorders.
- Local infection at the site of needle insertion.
- Uncontrolled respiratory or cardiac disorders.
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 |
|---|---|---|
| TAP BlockThe transabdominal plane (TAP) block is a regional anesthesia technique used for postoperative pain management in abdominal wall procedures, providing somatic analgesia to the anterior and lateral abdominal walls | Procedure or surgery | Combined, TAP block |
| Intrathecal morphine injectionIntrathecal injection of morphine plus 20 mg hyperbaric bupivacaine in spinal anesthesia | Drug | Combined, Intrathecal Morphine |
| spinal anesthesiaintrathecal injection of bupivacaine | Drug | Combined, Intrathecal Morphine, TAP block |
Primary outcome
Time to first analgesic request
Time frame: 24 hours
Time (in hours) until the patient demand additional analgesia.
3 secondary outcomes
Total analgesic consumption
Time frame: 24 hours
Time to ambulation
Time frame: 24 hours
complications
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
sohair Adeeb, assist.prof. principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAP Block, Intrathecal morphine injection and spinal anesthesia in people with Post-operative Pain Management, run by Minia 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 first analgesic request (time frame: 24 hours). 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 18 Mar 2025.