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NCT Number: NCT06720506

Comparsion Between Intrathecal Fentanyl and Intravenous Nalbuphine as a Postoperative Analgesia in Lower Limb Surgeries

Postoperative pain management has been a major challenge and there has been great interest about it ., there have been persistent efforts to bring out the best possible analgesic technique with the least side effects. The popularity of lower limb surgeries owing to its higher incidence, orthopedic and vascular surgerise. Inadequate postoperative pain relief is associated with undesirable side effects resulting in chronic persistent pain, delayed recovery Concern about opioid has powerful effect in relief post operative pain.

the aim of this study is to Compare between fentanyl intrathecal and nalbuphine IV as a postoperative analgesia in lower limb surgeries

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Fentanyl, a potent lipid-soluble opioid which was first synthesized more than 40years ago, is still the most popular opioid used as post operative analgesia t. Fentanyl given intrathecally use in many acute and chronic pain conditions. inspite of its side effects fentanyl remains the mainstay of anesthesiologists in post operative period analgesia.

Anesthetic methods of Lower limb surgery such as orthopedic and vascular surgeries, for example in the use of local infiltration, spinal anesthesia, caudal anesthesia, or general anesthesia Among them, spinal anesthesia is commonly used for lower limb surgery which does not need a sophisticated machine and which has been performed for years before anesthetic equipment such as mechanical ventilators and monitoring devices was produced. The development of new local anesthetic agents, the use of opioids, and an interest in acute and chronic pain management have universalized spinal anesthesia. Immediate pain is very severe in lowerlimb surgery and difficul to control. Moreover, due to the short hospitalization period, there is a limit in the application of patient-controlled analgesia that permits patients to treat pain by directly activating doses of opoids .

Nalbuphine...

Nalbuphine is an agonist-antagonist opioid and provides prolonged duration of analgesia with

fewer side effects of fentanyl such as pruritus, nausea, and vomiting.

Nalbuphine has a powerful effect in decreasing postoperative pain nNalbuphine IS asynthetic agonistant agonist opioid, demonstrated to attenuate mu-opioid receptor-related adverse events such as pruritis, nausea/emesis, constipation respiratory depression, undesirable sedation, and the development of toler ance and dependence. With several clinical reports, nalbuphine has been recognized as a safe and highly efficacious opioid analgesic that possesses remarkably low narcotic abuse liability. As a result, nalbuphine provides an alternative choice to replace strong opioids for the clinical practice of post- operative pain managemen

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male and female pt between 18 and 600 year
  • pt with lower limb surgeries with no. Indication for general anathesia
  • patient with no contraindication for spinal anatthesia

Exclusion criteria

  • pt who refuses
  • pt with hypersensivity to any drug
  • pt addicts opiods
  • chronic use of opiod
  • Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.

Treatment and study plan

Fentanyl

Drug

Fentanyl will be given intrathecal with dose 10-20ug

Nalbuphine

Drug

Nalbuphine will given IV as shot in Dose 1mg /kg

Primary outcomes

  1. first request of rescue analgesia

    Time frame: 24 hours

    Duration of analgesia until first analgesic request

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Khaled Helmy Abdelbasser, resident doctor

CONTACT

[email protected]

+2 01146445677

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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