Inguinal HerniaPhase 4NCT07837492
Ultrasound-Guided Ilioinguinal-Iliohypogastric Nerve Block Following Spinal Anesthesia Comparing Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Unilateral Inguinal Hernia Repair
A Phase 4 study testing Bupivacaine, Nalbuphine and Dexmedetomidine in people with Inguinal Hernia and Postoperative Pain, run by Assiut University.
Trial summary
This study evaluates and compares the pain-relieving efficacy and safety of adding either dexmedetomidine or nalbuphine to bupivacaine in an ultrasound-guided ilioinguinal-iliohypogastric nerve block for patients undergoing elective unilateral inguinal hernia repair under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inguinal Hernia, Postoperative Pain
- What is being tested?
- Bupivacaine, Nalbuphine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective unilateral primary inguinal hernia repair under spinal anesthesia supplemented with ilioinguinal-iliohypogastric nerve block
- Body weight between 45 and 100 kg and body mass index (BMI) <= 35 kg/m^2
- Ability to understand the study protocol, comply with study requirements, and communicate pain intensity using the Visual Analog Scale (VAS)
Who cannot join
- Known allergy or hypersensitivity to amide-type local anesthetics, dexmedetomidine, or nalbuphine
- Contraindications to spinal anesthesia (e.g., severe hypovolemia, elevated intracranial pressure, active infection at the lumbar puncture site, severe spinal deformity)
- History of neurological disorders (e.g., peripheral neuropathy, myopathy, seizure disorders, or cognitive impairment)
- Coagulopathy, concurrent anticoagulant therapy, or local infection at the block site contraindicating regional anesthesia
- Severe hepatic, renal, or cardiovascular disease (e.g., heart block, uncontrolled hypertension, ischemic heart disease, severe valvular disease, chronic renal failure, or liver cirrhosis)
- History of opioid or substance abuse
- Emergency surgical procedures
- Procedures expected to exceed 3 hours or requiring conversion to general anesthesia
About this study
Official title: Ultrasound-Guided Ilioinguinal-Iliohypogastric Nerve Block Following Spinal Anesthesia Comparing Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Unilateral Inguinal Hernia Repair: A Prospective, Randomized, Double-Blind Controlled Study
This study evaluates and compares the pain-relieving efficacy and safety of adding either dexmedetomidine or nalbuphine to bupivacaine in an ultrasound-guided ilioinguinal-iliohypogastric nerve block for patients undergoing elective unilateral inguinal hernia repair under spinal anesthesia.
While spinal anesthesia provides effective surgical anesthesia, postoperative pain often increases as the block recedes. Supplementing spinal anesthesia with an ultrasound-guided peripheral nerve block targeting the ilioinguinal and iliohypogastric nerves provides localized pain relief. Adding adjuvant medications to the local anesthetic may extend the duration of pain control and reduce systemic analgesic requirements.
Read more
Participants are randomly allocated to one of three groups:
- Control Group: Receives bupivacaine with normal saline.
- Nalbuphine Group: Receives bupivacaine combined with nalbuphine.
- Dexmedetomidine Group: Receives bupivacaine combined with dexmedetomidine.
The primary objective is to assess the duration of analgesia by measuring the time from the regression of spinal sensory anesthesia until the first request for rescue pain medication. Secondary objectives include evaluating total 24-hour pain medication consumption, postoperative pain scores, vital signs, sedation scores, patient satisfaction, and side effects.
- Conditions
- Inguinal Hernia, Postoperative Pain
- Being tested
- Bupivacaine, Nalbuphine, Dexmedetomidine
- Keywords
- Ilioinguinal-iliohypogastric nerve block, Dexmedetomidine, Nalbuphine, Bupivacaine, Spinal anesthesia, Postoperative analgesia
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Single-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with 2 mL sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%).
NalbuphineDrug
Single-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with nalbuphine 10 mg, diluted with sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%).
DexmedetomidineDrug
Single-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with dexmedetomidine 1 µg/kg, diluted with sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%).
| Study group | Role | What they receive |
|---|---|---|
| Group C: Bupivacaine Control | Active comparator | Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and 2 mL sterile normal saline (final bupivacaine concentration 0.4%). Receives: Drug: Bupivacaine |
| Group N: Nalbuphine Adjuvant | Experimental | Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and nalbuphine 10 mg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%). Receives: Drug: Bupivacaine; Drug: Nalbuphine |
| Group D: Dexmedetomidine Adjuvant | Experimental | Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and dexmedetomidine 1 µg/kg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%). Receives: Drug: Bupivacaine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Rescue Analgesia
Time in minutes from the documented regression of spinal sensory block to the T12 dermatome until the patient's first request for rescue analgesia, administered when the Visual Analog Scale (VAS) pain score is 4 or greater (scale of 0 = no pain to 10 = worst imaginable pain).
Measured: Up to 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 posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ayman Abd El-khaleq, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837492
- Sponsor's protocol ID
- Dex vs Nalbuphine: Nerve Block
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 23 Sep 2026
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Ilioinguinal-Iliohypogastric Nerve Block Following Spinal Anesthesia Comparing Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Unilateral Inguinal Hernia Repair: A Prospective, Randomized, Double-Blind Controlled Study
- ClinicalTrials.gov ID
- NCT07837492
- Acronym / sponsor ID
- Dex vs Nalbuphine: Nerve Block
- Conditions
- Inguinal Hernia, Postoperative Pain
- Keywords
- Ilioinguinal-iliohypogastric nerve block, Dexmedetomidine, Nalbuphine, Bupivacaine, Spinal anesthesia, Postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Sep 2026 (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 evaluates and compares the pain-relieving efficacy and safety of adding either dexmedetomidine or nalbuphine to bupivacaine in an ultrasound-guided ilioinguinal-iliohypogastric nerve block for patients undergoing elective unilateral inguinal hernia repair under spinal anesthesia.
While spinal anesthesia provides effective surgical anesthesia, postoperative pain often increases as the block recedes. Supplementing spinal anesthesia with an ultrasound-guided peripheral nerve block targeting the ilioinguinal and iliohypogastric nerves provides localized pain relief. Adding adjuvant medications to the local anesthetic may extend the duration of pain control and reduce systemic analgesic requirements.
Participants are randomly allocated to one of three groups:
- Control Group: Receives bupivacaine with normal saline.
- Nalbuphine Group: Receives bupivacaine combined with nalbuphine.
- Dexmedetomidine Group: Receives bupivacaine combined with dexmedetomidine.
The primary objective is to assess the duration of analgesia by measuring the time from the regression of spinal sensory anesthesia until the first request for rescue pain medication. Secondary objectives include evaluating total 24-hour pain medication consumption, postoperative pain scores, vital signs, sedation scores, patient satisfaction, and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C: Bupivacaine Control | Active comparator | Drug: BupivacainePatients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and 2 mL sterile normal saline (final bupivacaine concentration 0.4%). |
| Group N: Nalbuphine Adjuvant | Experimental | Drug: Bupivacaine, Drug: NalbuphinePatients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and nalbuphine 10 mg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%). |
| Group D: Dexmedetomidine Adjuvant | Experimental | Drug: Bupivacaine, Drug: DexmedetomidinePatients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and dexmedetomidine 1 µg/kg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective unilateral primary inguinal hernia repair under spinal anesthesia supplemented with ilioinguinal-iliohypogastric nerve block
- Body weight between 45 and 100 kg and body mass index (BMI) <= 35 kg/m^2
- Ability to understand the study protocol, comply with study requirements, and communicate pain intensity using the Visual Analog Scale (VAS)
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to amide-type local anesthetics, dexmedetomidine, or nalbuphine
- Contraindications to spinal anesthesia (e.g., severe hypovolemia, elevated intracranial pressure, active infection at the lumbar puncture site, severe spinal deformity)
- History of neurological disorders (e.g., peripheral neuropathy, myopathy, seizure disorders, or cognitive impairment)
- Coagulopathy, concurrent anticoagulant therapy, or local infection at the block site contraindicating regional anesthesia
- Severe hepatic, renal, or cardiovascular disease (e.g., heart block, uncontrolled hypertension, ischemic heart disease, severe valvular disease, chronic renal failure, or liver cirrhosis)
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 |
|---|---|---|
| BupivacaineSingle-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with 2 mL sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%). | Drug | Group C: Bupivacaine Control, Group D: Dexmedetomidine Adjuvant, Group N: Nalbuphine Adjuvant |
| NalbuphineSingle-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with nalbuphine 10 mg, diluted with sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%). | Drug | Group N: Nalbuphine Adjuvant |
| DexmedetomidineSingle-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with dexmedetomidine 1 µg/kg, diluted with sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%). | Drug | Group D: Dexmedetomidine Adjuvant |
Primary outcome
Time to First Rescue Analgesia
Time frame: Up to 24 hours postoperatively
Time in minutes from the documented regression of spinal sensory block to the T12 dermatome until the patient's first request for rescue analgesia, administered when the Visual Analog Scale (VAS) pain score is 4 or greater (scale of 0 = no pain to 10 = worst imaginable pain).
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 23 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine, Nalbuphine and Dexmedetomidine in people with Inguinal Hernia and Postoperative Pain, run by Assiut University.
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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Rescue Analgesia (time frame: Up to 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 23 Sep 2026.