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Completed

NCT Number: NCT06972654

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

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculity of medicine, Zagazig university, Zagazig

Zagazig, Egypt

About this study

  • To measure the time of first request of rescue analgesia , the total amount of rescue analgesic consumption (pethidine) in the first 24 hours post-operatively in each group and number of patients received one or two doses rescue analgesia.
  • To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive flexion or extension of hip (dynamic).
  • 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.
  • To assess Ease of Spinal Positioning (EOSP).
  • To assess patient satisfaction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients acceptance.
  • Age: Adults aged 21-75 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, II and Ⅲ..

*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).

Treatment and study plan

Group Nalupnine

Procedure

Patients 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.

group Dexamethasone

Procedure

Patients will receive a unilateral ultrasound-guided PENG block with a combination of 20 mL of bupivacaine 0.25%- 1 ml dexamethasone (4 mg) and 1 ml saline, with total volume 22ml

Primary outcomes

  1. The time to first request of rescue analgesia

    Time frame: 24 hours postoperative

    (time from end of local anesthetics injection in PENG block till time of NRS >3) will be recorded.

Secondary outcomes

  1. postoperative pain by Numerical Rating Scale

    Time frame: 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.

    To assess pain score by using numerical rate scale (NRS) at rest (static) and during passive flexion or extension of hip (dynamic) at different time points

  2. To assess the total amount of rescue analgesic consumption

    Time frame: 24 hours postoperative

    To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group

  3. To assess the incidence of drug-related side effects or block -related side effects

    Time frame: 24 hours postoperative

    To assess the incidence of drug-related side effects (such as nausea, vomiting, respiratory depression 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. Ease of Spinal Positioning (EOSP)

    Time frame: up to 15 minutes after giving the block

    evaluated on a scale from zero to three (zero = unable to be positioned; one = abnormal posture of the patient due to pain requiring support for positioning; two = mild discomfort but no need for assisted positioning; three = optimal condition where the patient could sit without feeling pain)

  5. patient's satisfaction

    Time frame: 24 hours postoperative

    overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)

  6. Number of patients received one or two doses rescue analgesia

    Time frame: 24 hours

    Number of patients received one or two doses rescue analgesia (pethidine) postoperative

  7. Length of hospital stay

    Time frame: up to 5 days

    number of hospital stay days starting from PACU discharge till home discharge

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study 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

Acronym: PENG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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