Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine
Primary Purpose
Inguinal Hernia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.
Sponsored by
About this trial
This is an interventional prevention trial for Inguinal Hernia focused on measuring nalbuphine, morphine, IV, Intrathecal
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patient refusal Allergy to the studied drugs. Patients with contraindications to spinal anesthesia ASA grade 3,4
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
group (1)
group (2)
Arm Description
who given intrathecal morphine thin IV nalbuphine and asize of 80 patients
who given intrathecal morphine onInguinal hernia druing spinal anathesia
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05704673
Brief Title
Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine
Official Title
Effect of IV Nalbuphine on Postoperative Nausea and Vomiting Following Intrathecal Morphine in Patients Undergoing Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
nalbuphine, morphine, IV, Intrathecal
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group (1)
Arm Type
Active Comparator
Arm Description
who given intrathecal morphine thin IV nalbuphine and asize of 80 patients
Arm Title
group (2)
Arm Type
Placebo Comparator
Arm Description
who given intrathecal morphine onInguinal hernia druing spinal anathesia
Intervention Type
Drug
Intervention Name(s)
nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.
Other Intervention Name(s)
nalbuphine, intrathecal morphine
Intervention Description
investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
Primary Outcome Measure Information:
Title
Effect of IV nalbuphine on postoperative nausea and vomiting following intrathecal morphine in patients undergoing inguinal hernia repair
Description
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).
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
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
males
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patient refusal
Allergy to the studied drugs.
Patients with contraindications to spinal anesthesia
ASA grade 3,4
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab Marzouk, master
Phone
01022290058
Email
e01022290058@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Fatma Asker, Professor
Phone
01005803969
Email
F.askar@aun.edu.eg
12. IPD Sharing Statement
Citations:
PubMed Identifier
29856176
Citation
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.
Results Reference
result
Learn more about this trial
Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine
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