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

NCT ID: NCT06972654

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-01-01

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 , 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.

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.

Conditions

Analgesia, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group Bupivacaine + nalbuphine (N)

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

Group Type: ACTIVE_COMPARATOR

Group Nalupnine

Intervention Type: 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 + dexamethasone (D)

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

Group Type: ACTIVE_COMPARATOR

Group Dexamethasone

Intervention Type: 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

Interventions

Group Nalupnine

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.

Intervention Type: PROCEDURE

Group Dexamethasone

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

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dina Abdelhameed Elsadek Salem

PRINCIPLE INVESTIGATOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculity of medicine, Zagazig university, Zagazig

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

1112

Identifier Type: -

Identifier Source: org_study_id