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

Zagazig University102 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

102

Conditions

Analgesia, Postoperative

Interventions

Group NalupninePROCEDURE

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 DexamethasonePROCEDURE

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Faculity of medicine, Zagazig university, Zagazig

Zagazig, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 24 hours postoperative

Secondary Outcomes

postoperative pain by Numerical Rating Scale

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

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 the total amount of rescue analgesic consumption

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

Time frame: 24 hours postoperative

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

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.

Time frame: 24 hours postoperative

Ease of Spinal Positioning (EOSP)

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)

Time frame: up to 15 minutes after giving the block

patient's satisfaction

Data from ClinicalTrials.gov

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