Clinical trial NCT06972654: Analgesic Effects of Combined Nalbuphine-bupivacaine Versus Dexamethasone-bupivacaine in Pericapsular Nerve Group Block (PENG) After Hip Surgeries: A Randomized Clinical Study
Official title: Efficacy of Combined Nalbuphine-bupivacaine Versus Dexamethasone-bupivacaine in Pericapsular Nerve Group Block (PENG) for Postoperative Analgesia in Hip Surgeries: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia, Postoperative
Keywords: nalbuphine-bupivacaine
ultrasound guided pericapsular nerve group (PENG)
dexamethasone-bupivacaine
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-05-15
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluate the efficacy of nalbuphine-bupivacaine vs dexamethasone-bupivacaine in ultrasound guided pericapsular nerve group (PENG) block for improving pain management, reducing opioid consumption, and enhancing the overall analgesic effect in patients undergoing hip surgeries
Primary purpose: TREATMENT

Brief summary: The aim of the study to Evaluate the efficacy of nalbuphine-bupivacaine vs dexamethasone-bupivacaine in ultrasound guided pericapsular nerve group (PENG) block for improving pain management, reducing opioid consumption, and enhancing the overall analgesic effect in patients undergoing hip surgeries.

Detailed description: 1. To measure the time of first request of rescue analgesia and to assess the total amount of rescue analgesic consumption (pethidine) in the first 24 hours post-operatively in each group.
2. To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive flexion or extension of hip (dynamic).
3. To assess the incidence of drug-related side effects (such as nausea, vomiting, bradycardia, hypotension, sedation and hyperglycemia) or block -related side effects (hematoma, infection or LA toxicity) in patients receiving either nalbuphine or dexamethasone as adjuvant to bupivacaine in the PENG block.
4. To assess Ease of Spinal Positioning (EOSP).
5. To assess patient satisfaction.

Eligibility criteria: Inclusion criteria:

* Patients acceptance.
* Age: Adults aged 21-64 years old.
* BMI: 25-30 kg/m2
* Sex: both sexes (males or females).
* Patients undergoing unilateral hip surgery under spinal anesthesia.
* ASA (American Society of Anesthesiologists) physical status classification I to II.

  \*Exclusion criteria:
* Patients with contraindications to regional anesthesia (e.g. local or systemic infections, or severe neurological or muscular disorders or patient on anticoagulant).
* Allergy to study drugs: bupivacaine or nalbuphine or dexamethasone
* Patients with severe cardiovascular, respiratory, renal, or hepatic conditions, uncontrolled diabetes diseases, or those undergoing chronic opioid therapy.
* Psychiatric disorders that hinder informed consent or study participation.
* history of neurological diseases or conditions that would affect the efficacy of nerve blocks (e.g., neuropathy, spinal cord injury, or history of severe muscle weakness).

Primary outcomes:
measure: The time to first request of rescue analgesia
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: postoperative pain by Numerical Rating Scale
timeFrame: Basal (before giving the block), 15 minutes after giving the block and before spinal anesthesia, PACU ( after arrival to PACU 0 minute), 2 hours (hrs), 4 hrs, 8 hrs, 12 hrs and 24 hrs.
measure: To assess the total amount of rescue analgesic consumption
timeFrame: 24 hours postoperative
measure: The time to first postoperative out of bed mobilization and length of hospital stay
timeFrame: 72 hrs postoperative
measure: To assess the incidence of drug-related side effects or block -related side effects
timeFrame: 24 hours postoperative
measure: Ease of Spinal Positioning (EOSP)
timeFrame: up to 15 minutes after giving the block
measure: patient's satisfaction
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculity of medicine, Zagazig university, Zagazig
Study officials:
References: