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

NCT06972654 | Completed

• 1 other identifier: 1112
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia, Postoperative

Keywords

nalbuphine-bupivacaine; ultrasound guided pericapsular nerve group (PENG); dexamethasone-bupivacaine

Outcome Measures

Primary Outcomes (1)

• The time to first request of rescue analgesia

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

  24 hours postoperative

Secondary Outcomes (7)

• postoperative pain by Numerical Rating Scale

  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 the total amount of rescue analgesic consumption

  24 hours postoperative

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

  24 hours postoperative

• Ease of Spinal Positioning (EOSP)

  up to 15 minutes after giving the block

• patient's satisfaction

  24 hours postoperative

Study Arms (2)

Group Bupivacaine + nalbuphine (N)

ACTIVE COMPARATOR

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

Procedure: Group Nalupnine

Group Bupivacaine + dexamethasone (D)

ACTIVE COMPARATOR

Patients in this group 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

Procedure: Group Dexamethasone

Interventions

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 Bupivacaine + nalbuphine (N)

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

Group Bupivacaine + dexamethasone (D)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculity of medicine, Zagazig university, Zagazig

Zagazig, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Anesthetist not sharing in the study will assess patient
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPLE INVESTIGATOR

Model Details: 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

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: May 15, 2025
• Study Start: April 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)