a Small Dose of Naloxone,Minimize Intrathecal Morphine Side Effects

NCT ID: NCT03230474

Last Updated: 2017-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-04-30

Brief Summary

I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis, nausea/emesis, constipation, urinary retention, respiratory depression and undesirable sedation) so using it as additive to intrathecal morphine in patients undergoing anal surgeries under spinal anesthesia may be beneficail

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, therefore, various additives have been used along with bupivacaine for the prolongation of its effect, to improve the quality of analgesia, and to minimize the requirement for postoperative analgesics .

Opioids may be added to local anesthetic solutions to enhance surgical anesthesia and provide postoperative analgesia . This effect is mediated at the dorsal horn of the spinal cord, where opioids mimic the effect of endogenous enkephalins. The use of intrathecal (IT) morphine (0.1 to 0.5 mg) can provide effective control of postoperative pain for roughly 24 hours . However, the use of IT morphine may result in serious side effects e.g. pruritus 53%, nausea and vomiting 43%.urinary retention 43% and delayed respiratory depression . These side effects may lead to patient discomfort and prolonged hospital stay thus limiting the usefulness of IT morphine.

Naloxone has an extremely high affinity for μ-opioid receptors in the central nervous system (CNS). Naloxone is a μ-opioid receptor (MOR) competitive antagonist, and its rapid blockade of those receptors often produces rapid onset of withdrawal symptoms. Naloxone also has an antagonist action, though with a lower affinity, at κ- (KOR) and δ-opioid receptors (DOR). Unlike other opioid receptor antagonists, naloxone is essentially a pure antagonist with no agonist properties.

I.V naloxone decreases incidence and severity of the common morphine side effects (pruritis, nausea/emesis, constipation, urinary retention, respiratory depression and undesirable sedation) The addition of naloxone to morphine decreases the opioid related side effects without affection of postoperative analgesia. This combination can be used for the treatment of severe refractory chronic low back pain.

Conditions

Post-Op Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group 1

50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 0.5 ml as placebo (total volume 2 mL)

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 0.5 ml as placebo (total volume 2 mL)

group 2

50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 5ng\\ kg naloxone in 0.5 ml volume (total volume 2mL).

Group Type: ACTIVE_COMPARATOR

Morphine-Naloxone

Intervention Type: DRUG

50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 5ng\\ kg naloxone in 0.5 ml volume (total volume 2mL).

Interventions

Morphine

50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 0.5 ml as placebo (total volume 2 mL)

Intervention Type: DRUG

Morphine-Naloxone

50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 5ng\\ kg naloxone in 0.5 ml volume (total volume 2mL).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ASA physical status I - II
• undergoing anal surgery with spinal anesthesia

Exclusion Criteria

• Renal ,hepatic and cardiac patients -Infection at the site of injection.-
• Coagulopathy or other bleeding diathesis. -Preexisting neurologic deficits.-
• History of hypersensitivity to any of the given the drugs.
• Inability to communicate with the investigator and the hospital staff.
• History of chronic opioid use.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Emad Zarief , MD

Lecturer of anesthesia and ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emad Zarief Kamel Said

Asyut, , Egypt

Countries

Egypt

Other Identifiers

IRB00009914

Identifier Type: -

Identifier Source: org_study_id