Analgesia, Postoperative
Conditions
Keywords
nalbuphine-bupivacaine, ultrasound guided pericapsular nerve group (PENG), dexamethasone-bupivacaine
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.
Interventions
PROCEDUREGroup 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.
PROCEDUREGroup 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
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Anesthetist not sharing in the study will assess patient
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time to first request of rescue analgesia | 24 hours postoperative | (time from end of local anesthetics injection in PENG block till time of NRS \>3) will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 pain score by using numerical rate scale (NRS) at rest (static) and during passive flexion or extension of hip (dynamic) at different time points |
| To assess the total amount of rescue analgesic consumption | 24 hours postoperative | To assess the total amount of rescue analgesic consumption in the first 24 hours post-operatively in each group |
| To assess the incidence of drug-related side effects or block -related side effects | 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. |
| Ease of Spinal Positioning (EOSP) | 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) |
| patient's satisfaction | 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) |
| Number of patients received one or two doses rescue analgesia | 24 hours | Number of patients received one or two doses rescue analgesia (pethidine) postoperative |
| Length of hospital stay | up to 5 days | number of hospital stay days starting from PACU discharge till home discharge |
Countries
Egypt
Outcome results
None listed