Ultrasound-Guided Ilioinguinal-Iliohypogastric Nerve Block Following Spinal Anesthesia Comparing Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Unilateral Inguinal Hernia Repair

NCT07837492 | Not Yet Recruiting Phase 4

• 1 other identifier: Dex vs Nalbuphine: Nerve Block
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Inguinal Hernia; Postoperative Pain

Keywords

Ilioinguinal-iliohypogastric nerve block; Dexmedetomidine; Nalbuphine; Bupivacaine; Spinal anesthesia; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 24 hours postoperatively

Study Arms (3)

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%).

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%).

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%).

Drug: Bupivacaine; Drug: Dexmedetomidine

Interventions

Bupivacaine DRUG

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%).

Group C: Bupivacaine Control; Group D: Dexmedetomidine Adjuvant; Group N: Nalbuphine Adjuvant

Nalbuphine DRUG

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%).

Group N: Nalbuphine Adjuvant

Dexmedetomidine DRUG

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%).

Group D: Dexmedetomidine Adjuvant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

Bupivacaine; Nalbuphine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09