Postoperative AnalgesiaPhase 3NCT06812741
Duration of Postop Analgesia After Inguinal Hernia Surgery Treated with TAP Block Vs II/IH Nerve Block
A Phase 3 study testing Transversus abdominis plane (TAP) block with 0.25 % bupivacaine and Ilioinguinal/iliohypogastric Nerve Block with 0.25 % bupivacaine in people with Postoperative Analgesia, run by Pakistan Navy Station Shifa Hospital at 1 site in Pakistan.
Trial summary
Comparing Postop Analgesia after Inguinal Hernia Surgery treated with TAP Block Vs Ilioinguinal/ Iliohypogastric Nerve Block Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Transversus abdominis plane (TAP) block with 0.25 % bupivacaine and Ilioinguinal/iliohypogastric Nerve Block with 0.25 % bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Feb 2024to 28 Jul 2024
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients giving written informed consent
- Patients undergoing Inguinal Hernia surgery
- patients with ages 18-60 years
- ASA 1 and 2 patients
Who cannot join
- INR > 1.0 (patients with bleeding tendency)
- EF < 45 % (patients with cardiac dysfunction)
- FEV1 < 80 % of normal (patients with pulmonary dysfunction)
- patients with renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Mean Duration of Postoperative Analgesia in Patients Undergoing Inguinal Hernia Surgery Treated with Transversus Abdominal Plane Block Vs Ilioinguinal and Iliohypogastric Nerve Blocks
Comparing Postop Analgesia after Inguinal Hernia Surgery treated with TAP Block Vs Ilioinguinal/ Iliohypogastric Nerve Block
Read the detailed description
Comparison of Mean Duration of Postoperative Analgesia in Patients undergoing Inguinal Hernia Surgery treated with Transversus Abdominal Plane Block Versus Ilioinguinal/ Iliohypogastric Nerve Block
- Conditions
- Postoperative Analgesia
- Being tested
- Transversus abdominis plane (TAP) block with 0.25 % bupivacaine, Ilioinguinal/iliohypogastric Nerve Block with 0.25 % bupivacaine
- Keywords
- postop analgesia, postoperative analgesia, TAP block, transversus abdominis plane block, ilioinguinal/ iliohypogastric nerve block, ilioinguinal/iliohypogastric nerve block, inguinal hernia surgery, abdominal nerve block, nerve block, nerve blocks, bupivacaine, ultrasound guided nerve block, ultrasound guided nerve blocks, 0.25% bupivacaine, 0.25 percent bupivacaine, hernioplasty, internal oblique, transversus abdominis, IIN, IHN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane (TAP) block with 0.25 % bupivacaineDrug
The probe was placed in a plane transverse to the lateral abdominal wall in the mid-axillary line immediately cephalad to the iliac crest. The needle was advanced immediately anterior to the probe using the in-plane needle-probe orientation and advanced posteriorly until the needle was observed to penetrate the interface between the internal oblique and transversus abdominis muscles. Thereafter, a local anesthetic (0.2 mL/kg of 0.25 % bupivacaine) was injected incrementally, and the spread was observed within the plane.
Ilioinguinal/iliohypogastric Nerve Block with 0.25 % bupivacaineDrug
The ultrasound probe was placed immediately medial and slightly cephalad to the upper aspect of the anterior superior iliac spine to obtain a short-axis view of the nerves situated between the two abdominal muscles (internal oblique and transversus abdominis), A 22 G needle tip ~1 cm caudal to the probe surface was introduced and was advanced until a characteristic 'tenting' of the interface between the two muscles was seen and was then further advanced deep to this interface until a pop was felt and then the injectate (0.2 mL/kg of 0.25 % bupivacaine) was observed spreading between these two layers.
| Study group | Role | What they receive |
|---|---|---|
| Inguinal Hernia Surgery (Group T) | Experimental | Half of the study participants named Group T were administered Ultrasound Guided Transversus Abdominis Plane Nerve Block and the other half named Group I were administered Ilioinguinal \& Iliohypogastric Nerve Block before the Inguinal Hernia Surgery. Receives: Drug: Transversus abdominis plane (TAP) block with 0.25 % bupivacaine |
| Inguinal Hernia Surgery (Group I) | Experimental | Half of the study participants named Group T were administered Ultrasound Guided Transversus Abdominis Plane Nerve Block and the other half named Group I were administered Ilioinguinal \& Iliohypogastric Nerve Block before the Inguinal Hernia Surgery. Receives: Drug: Ilioinguinal/iliohypogastric Nerve Block with 0.25 % bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration of Postoperative Analgesia
The study was conducted to compare the mean duration of postoperative analgesia in patients undergoing inguinal hernia repair surgery treated with transversus abdominis plane block versus the mean duration of postoperative analgesia in patients undergoing inguinal hernia repair surgery treated with ilioinguinal and iliohypogastric nerve block.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start9 Feb 2024
- Primary completion28 Jul 2024
- Study completion28 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Navy Station Shifa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenan Anwar Khan, Pakistan Navy Station Shifa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812741
- Sponsor's protocol ID
- 530/ 2024
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mean Duration of Postoperative Analgesia in Patients Undergoing Inguinal Hernia Surgery Treated with Transversus Abdominal Plane Block Vs Ilioinguinal and Iliohypogastric Nerve Blocks
- ClinicalTrials.gov ID
- NCT06812741
- Acronym / sponsor ID
- 530/ 2024
- Conditions
- Postoperative Analgesia
- Keywords
- postop analgesia, postoperative analgesia, TAP block, transversus abdominis plane block, ilioinguinal/ iliohypogastric nerve block, ilioinguinal/iliohypogastric nerve block, inguinal hernia surgery, abdominal nerve block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pakistan Navy Station Shifa HospitalUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 28 Jul 2024 (actual)
- First posted
- 6 Feb 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.
Comparing Postop Analgesia after Inguinal Hernia Surgery treated with TAP Block Vs Ilioinguinal/ Iliohypogastric Nerve Block
Detailed description
Comparison of Mean Duration of Postoperative Analgesia in Patients undergoing Inguinal Hernia Surgery treated with Transversus Abdominal Plane Block Versus Ilioinguinal/ Iliohypogastric Nerve Block
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inguinal Hernia Surgery (Group T) | Experimental | Drug: Transversus abdominis plane (TAP) block with 0.25 % bupivacaineHalf of the study participants named Group T were administered Ultrasound Guided Transversus Abdominis Plane Nerve Block and the other half named Group I were administered Ilioinguinal \& Iliohypogastric Nerve Block before the Inguinal Hernia Surgery. |
| Inguinal Hernia Surgery (Group I) | Experimental | Drug: Ilioinguinal/iliohypogastric Nerve Block with 0.25 % bupivacaineHalf of the study participants named Group T were administered Ultrasound Guided Transversus Abdominis Plane Nerve Block and the other half named Group I were administered Ilioinguinal \& Iliohypogastric Nerve Block before the Inguinal Hernia Surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients giving written informed consent
- Patients undergoing Inguinal Hernia surgery
- patients with ages 18-60 years
- ASA 1 and 2 patients
Key exclusion criteria (4 listed)
- INR > 1.0 (patients with bleeding tendency)
- EF < 45 % (patients with cardiac dysfunction)
- FEV1 < 80 % of normal (patients with pulmonary dysfunction)
- patients with renal disease
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 plane (TAP) block with 0.25 % bupivacaineThe probe was placed in a plane transverse to the lateral abdominal wall in the mid-axillary line immediately cephalad to the iliac crest. The needle was advanced immediately anterior to the probe using the in-plane needle-probe orientation and advanced posteriorly until the needle was observed to penetrate the interface between the internal oblique and transversus abdominis muscles. Thereafter, a local anesthetic (0.2 mL/kg of 0.25 % bupivacaine) was injected incrementally, and the spread was observed within the plane. | Drug | Inguinal Hernia Surgery (Group T) |
| Ilioinguinal/iliohypogastric Nerve Block with 0.25 % bupivacaineThe ultrasound probe was placed immediately medial and slightly cephalad to the upper aspect of the anterior superior iliac spine to obtain a short-axis view of the nerves situated between the two abdominal muscles (internal oblique and transversus abdominis), A 22 G needle tip ~1 cm caudal to the probe surface was introduced and was advanced until a characteristic 'tenting' of the interface between the two muscles was seen and was then further advanced deep to this interface until a pop was felt and then the injectate (0.2 mL/kg of 0.25 % bupivacaine) was observed spreading between these two layers. | Drug | Inguinal Hernia Surgery (Group I) |
Primary outcome
Mean duration of Postoperative Analgesia
Time frame: 6 months
The study was conducted to compare the mean duration of postoperative analgesia in patients undergoing inguinal hernia repair surgery treated with transversus abdominis plane block versus the mean duration of postoperative analgesia in patients undergoing inguinal hernia repair surgery treated with ilioinguinal and iliohypogastric nerve block.
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 28 Feb 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.
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 Phase 3 study testing Transversus abdominis plane (TAP) block with 0.25 % bupivacaine and Ilioinguinal/iliohypogastric Nerve Block with 0.25 % bupivacaine in people with Postoperative Analgesia, run by Pakistan Navy Station Shifa Hospital at 1 site in Pakistan.
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 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 28 Feb 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 Pakistan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean duration of Postoperative Analgesia (time frame: 6 months). 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 28 Feb 2025.