Analgesia, PostoperativePENGNCT06972654
Analgesic Effects of Combined Nalbuphine-bupivacaine Versus Dexamethasone-bupivacaine in Pericapsular Nerve Group Block (PENG) After Hip Surgeries: A Randomized Clinical Study
A study testing Group Nalupnine and Group Dexamethasone in people with Analgesia, Postoperative, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Postoperative
- What is being tested?
- Group Nalupnine and Group Dexamethasone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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..
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
- 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.
- Conditions
- Analgesia, Postoperative
- Being tested
- Group Nalupnine, Group Dexamethasone
- Keywords
- nalbuphine-bupivacaine, ultrasound guided pericapsular nerve group (PENG), dexamethasone-bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group NalupnineProcedure or surgery
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 or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Group Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperative
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: 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)
Measured: up to 15 minutes after giving the block
patient's satisfaction
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)
Measured: 24 hours postoperative
Number of patients received one or two doses rescue analgesia
Number of patients received one or two doses rescue analgesia (pethidine) postoperative
Measured: 24 hours
Length of hospital stay
number of hospital stay days starting from PACU discharge till home discharge
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Apr 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, PostoperativeStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972654
- Sponsor's protocol ID
- 1112
- Acronym
- PENG
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06972654
- Acronym / sponsor ID
- PENG / 1112
- Conditions
- Analgesia, Postoperative
- Keywords
- nalbuphine-bupivacaine, ultrasound guided pericapsular nerve group (PENG), dexamethasone-bupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group Bupivacaine + nalbuphine (N) | Active comparator | Procedure: Group NalupninePatients 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 Bupivacaine + dexamethasone (D) | Active comparator | Procedure: Group DexamethasonePatients 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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group NalupninePatients 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 or surgery | Group Bupivacaine + nalbuphine (N) |
| Group DexamethasonePatients 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 or surgery | Group Bupivacaine + dexamethasone (D) |
Primary outcome
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.
7 secondary outcomes
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 the total amount of rescue analgesic consumption
Time frame: 24 hours postoperative
To assess the incidence of drug-related side effects or block -related side effects
Time frame: 24 hours postoperative
Ease of Spinal Positioning (EOSP)
Time frame: up to 15 minutes after giving the block
patient's satisfaction
Time frame: 24 hours postoperative
Number of patients received one or two doses rescue analgesia
Time frame: 24 hours
Length of hospital stay
Time frame: up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Nalupnine and Group Dexamethasone in people with Analgesia, Postoperative, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to first request of rescue analgesia (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.