Inguinal HerniaNCT05704673
Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine
A study of Inguinal Hernia, run by Assiut University.
Trial summary
the study aimed to investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery. Read more about this study
- Who is it for?
- Ages 15 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to Jun 2024
- 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 15 to 70 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients of aged 15-70years old
- males
- Scheduled patients for inguinal hernia repair surgery with under spinal anesthesia.
- ASA grade 1,2
- normal cardiac and renal function
Who cannot join
- Patient refusal
- Allergy to the studied drugs.
- Patients with contraindications to spinal anesthesia
- ASA grade 3,4
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of IV Nalbuphine on Postoperative Nausea and Vomiting Following Intrathecal Morphine in Patients Undergoing Inguinal Hernia Repair
the study aimed to investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
Read the detailed description
Bupivacaine hydrochloride is a commonly used local anesthetic in spinal anesthesia, however, the duration of spinal analgesia by bupivacaine is limited to about 75- 150 minutes.2 Therefore, various additives have been used with bupivacaine to prolong its effects and improve the quality of analgesia.(1) Opioids are the most popular used adjuvants added to bupivacaine in spinal blockade to obtain a sufficient intraoperative visceral analgesia and increase the duration and quality of postoperative analgesia, with less sympathetic block and hemodynamic effect .(2) morphine is commonly used for analgesia, but is frequently associated with postoperative nausea and vomiting (PONV) and pruritus, These side effects may lead to patient discomfort and prolonged hospital stay thus limiting the usefulness of IT morphine.
Nalbuphine is a mu receptor antagonist and a ĸappa receptor agonist.10 When added as an adjunct to intrathecal local anesthetics, it provides good analgesia with decreased incidence and severity of mu receptor side effects(3) Morphine binds most readily to the mu-opioid receptor and less well to the kappa-opioid receptor. So, the undesirable adverse events of morphine are thought to result from agonism at the mu-opioid receptor.5 Many drugs have been tried with morphine to potentiate its analgesic effects or to reduce the adverse events.6 Nalbuphine is a mixed opioid agonist-antagonist that acts mainly through kappa-opioid receptors, and it may attenuate mu-opioid receptor related side effects.3 Moreover, recent studies suggested that the analgesic effects of morphine and nalbuphine may be additive.
The addition of nalbuphine to intrathecal bupivacaine plus morphine significantly reduced the incidence and severity of postoperative nausea and vomiting and pruritus without affecting analgesic potency..(4)
- Conditions
- Inguinal Hernia
- Being tested
- nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.
- Keywords
- nalbuphine, morphine, IV, Intrathecal
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.Drug
Also called nalbuphine, intrathecal morphine
investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
| Study group | Role | What they receive |
|---|---|---|
| group (1) | Active comparator | who given intrathecal morphine thin IV nalbuphine and asize of 80 patients Receives: Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study. |
| group (2) | Placebo comparator | who given intrathecal morphine onInguinal hernia druing spinal anathesia Receives: Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of IV nalbuphine on postoperative nausea and vomiting following intrathecal morphine in patients undergoing inguinal hernia repair
investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea to 3 sever vomating).
A verbal descriptive scale (VDS) was used to assess the severity of PONV b. Secondary (subsidiary): postoperative pain and puririts. [ Time Frame: 24 hours ] c. Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 3).
Measured: 1. a. Primary (main): postoperative nausea and vomiting [ Time Frame: 24 hours ] A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Jun 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Marzouk Gomaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704673
- Sponsor's protocol ID
- 17101956
- Status last verified
- May 2023
- First submitted
- 20 Jan 2023
- Last updated
- 8 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ibrahim AS, Aly MG, Thabet ME, Abdelaziz MR. Effect of adding nalbuphine to intrathecal bupivacaine with morphine on postoperative nausea and vomiting and pruritus after elective cesarean delivery: a randomized double blinded study. Minerva Anestesiol. 2019 Mar;85(3):255-262. doi: 10.23736/S0375-9393.18.12751-9. Epub 2018 May 30.
PubMed 29856176
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of IV Nalbuphine on Postoperative Nausea and Vomiting Following Intrathecal Morphine in Patients Undergoing Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT05704673
- Acronym / sponsor ID
- 17101956
- Conditions
- Inguinal Hernia
- Keywords
- nalbuphine, morphine, IV, Intrathecal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 30 Jan 2023 (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 study aimed to investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
Detailed description
Bupivacaine hydrochloride is a commonly used local anesthetic in spinal anesthesia, however, the duration of spinal analgesia by bupivacaine is limited to about 75- 150 minutes.2 Therefore, various additives have been used with bupivacaine to prolong its effects and improve the quality of analgesia.(1) Opioids are the most popular used adjuvants added to bupivacaine in spinal blockade to obtain a sufficient intraoperative visceral analgesia and increase the duration and quality of postoperative analgesia, with less sympathetic block and hemodynamic effect .(2) morphine is commonly used for analgesia, but is frequently associated with postoperative nausea and vomiting (PONV) and pruritus, These side effects may lead to patient discomfort and prolonged hospital stay thus limiting the usefulness of IT morphine.
Nalbuphine is a mu receptor antagonist and a ĸappa receptor agonist.10 When added as an adjunct to intrathecal local anesthetics, it provides good analgesia with decreased incidence and severity of mu receptor side effects(3) Morphine binds most readily to the mu-opioid receptor and less well to the kappa-opioid receptor. So, the undesirable adverse events of morphine are thought to result from agonism at the mu-opioid receptor.5 Many drugs have been tried with morphine to potentiate its analgesic effects or to reduce the adverse events.6 Nalbuphine is a mixed opioid agonist-antagonist that acts mainly through kappa-opioid receptors, and it may attenuate mu-opioid receptor related side effects.3 Moreover, recent studies suggested that the analgesic effects of morphine and nalbuphine may be additive.
The addition of nalbuphine to intrathecal bupivacaine plus morphine significantly reduced the incidence and severity of postoperative nausea and vomiting and pruritus without affecting analgesic potency..(4)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group (1) | Active comparator | Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.who given intrathecal morphine thin IV nalbuphine and asize of 80 patients |
| group (2) | Placebo comparator | Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.who given intrathecal morphine onInguinal hernia druing spinal anathesia |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- patients of aged 15-70years old
- males
- Scheduled patients for inguinal hernia repair surgery with under spinal anesthesia.
- ASA grade 1,2
- normal cardiac and renal function
Key exclusion criteria (4 listed)
- Patient refusal
- Allergy to the studied drugs.
- Patients with contraindications to spinal anesthesia
- ASA grade 3,4
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 |
|---|---|---|
| nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.Also: nalbuphine, intrathecal morphineinvestigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery. | Drug | group (1), group (2) |
Primary outcome
Effect of IV nalbuphine on postoperative nausea and vomiting following intrathecal morphine in patients undergoing inguinal hernia repair
Time frame: 1. a. Primary (main): postoperative nausea and vomiting [ Time Frame: 24 hours ] A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea
investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery. A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea to 3 sever vomating). A verbal descriptive scale (VDS) was used to assess the severity of PONV b. Secondary (subsidiary): postoperative pain and puririts. [ Time Frame: 24 hours ] c. Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Results publication: PubMed 29856176Ibrahim AS, Aly MG, Thabet ME, Abdelaziz MR. Effect of adding nalbuphine to intrathecal bupivacaine with morphine on postoperative nausea and vomiting and pruritus after elective cesarean delivery: a randomized double blinded study. Minerva Anestesiol. 2019 Mar;85(3):255-262. doi: 10.23736/S0375-9393.18.12751-9. Epub 2018 May 30.
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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.
Questions about this trial
What is this clinical trial studying?
A study of Inguinal Hernia, run by Assiut University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rehab Marzouk, master (01022290058, e01022290058@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of IV nalbuphine on postoperative nausea and vomiting following intrathecal morphine in patients undergoing inguinal hernia repair (time frame: 1. a. Primary (main): postoperative nausea and vomiting [ Time Frame: 24 hours ] A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704673, which also lists 1 linked publication.
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 8 May 2023.