Analgesic Effects of Combined Nalbuphine-bupivacaine Versus Dexamethasone-bupivacaine in Pericapsular Nerve Group Block (PENG) After Hip Surgeries: A Randomized Clinical Study

Zagazig University

Status: Enrolling

Conditions: Analgesia, Postoperative

Treatments: Procedure: Group Dexamethasone; Procedure: Group Nalupnine

Study type: Interventional

Funder types: Other

Identifiers

NCT06972654

1112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

Group Bupivacaine + nalbuphine (N)

Active Comparator group

Description:

Patients in this group will receive a unilateral ultrasound-guided pericapsular nerve group (PENG) block with a combination of 20 mL of bupivacaine 0.25%- and 2 ml nalbuphine (20 mg), with total volume 22ml

Treatment:

Procedure: Group Nalupnine

Group Bupivacaine + dexamethasone (D)

Active Comparator group

Description:

Patients in this group will receive a unilateral ultrasound-guided PENG block with a combination of 20 mL of bupivacaine 0.25%- and 2 ml dexamethasone (8 mg), with total volume 22ml

Treatment:

Procedure: Group Dexamethasone