A Phase 3 interventional study of Dexmedetomidine and Bupivacaine in Hypospadias Repair Surgery, sponsored by Assiut University. Not yet recruiting. Open to participants aged 6 Months to 7 Years. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
The main issue with pain management in children especially young children is the difficulty involved in evaluating it. When a patient's level of pain cannot be accurately assessed, effective analgesia cannot be prescribed. When children are not sufficiently treated for pain, stress hormones are released into their systems, resulting in increased catabolism, immunosuppression and hemodynamic instability .
Peripheral nerve blocks may be favored over neuroaxial blocks because they allow quicker mobilization after surgery.
Hypospadias results from abnormal development of the penis that leaves the urethral meatus proximal to its normal glanular position anywhere along the penile shaft, scrotum, or perineum. A spectrum of abnormalities, including ventral curvature of the penis (chordee), a hooded incomplete prepuce, and an abortive corpora spongiosum, are commonly associated with hypospadias. Surgical correction is typically performed during early childhood to restore normal appearance and function.
Penile block is a widely used regional anesthesia technique for hypospadias repair, It involves the administration of a local anesthetic around the penile nerve, providing effective pain relief during and after surgery. While effective, the duration of analgesia provided by a penile block with local anesthetics alone is often limited, necessitating the use of additional analgesics in the postoperative period.
Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic properties. It has been increasingly used as an adjuvant in regional anesthesia to prolong the duration of analgesia and reduce opioid consumption .
The addition of dexmedetomidine to local anesthetics has been shown to enhance the quality and duration of nerve blocks in various surgical settings but its efficacy in penile block for pediatric hypospadias repair has not been extensively studied.
the aim of the study To assess the duration of analgesia provided by the penile block with dexmedetomidine.
Timing and episodes of rescue analgesia consumption . To monitor and report any adverse effects associated with the use of dexmedetomidine such as hypotension and bradycardia
The main issue with pain management in children especially young children is the difficulty involved in evaluating it. When a patient's level of pain cannot be accurately assessed, effective analgesia cannot be prescribed. When children are not sufficiently treated for pain, stress hormones are released into their systems, resulting in increased catabolism, immunosuppression and hemodynamic instability .
Peripheral nerve blocks may be favored over neuroaxial blocks because they allow quicker mobilization after surgery.
Hypospadias results from abnormal development of the penis that leaves the urethral meatus proximal to its normal glanular position anywhere along the penile shaft, scrotum, or perineum. A spectrum of abnormalities, including ventral curvature of the penis (chordee), a hooded incomplete prepuce, and an abortive corpora spongiosum, are commonly associated with hypospadias. Surgical correction is typically performed during early childhood to restore normal appearance and function.
Penile block is a widely used regional anesthesia technique for hypospadias repair, It involves the administration of a local anesthetic around the penile nerve, providing effective pain relief during and after surgery. While effective, the duration of analgesia provided by a penile block with local anesthetics alone is often limited, necessitating the use of additional analgesics in the postoperative period.
Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic properties. It has been increasingly used as an adjuvant in regional anesthesia to prolong the duration of analgesia and reduce opioid consumption .
The addition of dexmedetomidine to local anesthetics has been shown to enhance the quality and duration of nerve blocks in various surgical settings but its efficacy in penile block for pediatric hypospadias repair has not been extensively studied.
Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
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Exclusion Criteria:
Penile block with bupivacaine 0.25% (0.2 ml/kg) plus dexmedetomidine (0.5 mcg/kg)
Drug: Dexmedetomidine · Drug: Bupivacaine
Penile block with bupivacaine 0.25% (0.2 ml/kg) only
Drug: Bupivacaine
Patients will receive dexmedetomidine (0.5 mcg/kg).
Penile block with bupivacaine 0.25% (0.2 ml/kg)
FLACC Pain score
FLACC Pain score (Face,Leg,Activity,Cry,Consolability) in pediatric patients undergoing hypospadias repair(post-operative). A total score between 0 and 10 It will be measured at the recovery room and 2,6,12,24 hours posoprtatively
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine