Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine

May 5, 2023 updated by: Rehab Marzouk Gomaa, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group (1)
who given intrathecal morphine thin IV nalbuphine and asize of 80 patients
Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.
investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
Other Names:
  • nalbuphine
  • intrathecal morphine
Placebo Comparator: group (2)
who given intrathecal morphine onInguinal hernia druing spinal anathesia
Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.
investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
Other Names:
  • nalbuphine
  • intrathecal morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17101956

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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