Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia

NCT05389813 | Unknown Phase 2 DMC

• 1 other identifier: Preemptive Analgesia
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The research will be conducted between March 2021 and June 2023. All patients scheduled electively for one of four surgeries (Laparoscopic Cholecystectomy, Submucosal resection, Breast lumpectomy, and median laparotomy) at that period of time at An-Najah National University hospital will be included in the research sample, unless not meeting with the criteria put. Primary objectives are: To evaluate the effectiveness of preemptive analgesia on postoperative pain relief and shorter hospital stay for adults undergoing surgical procedures, according to the type of surgery and the type of drug. To compare the effect of a single oral preemptive dose of Pregabalin versus Oxycodone on postoperative pain relief, in terms of pain intensity as assessed by pain numeric rating scale (NRS)

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (5)

• Preoperative pain

  The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening. This will have 2 contents: * NRS at rest. * NRS at movement.

  30 minutes preoperative

• Postoperative pain

  The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening.

  at 0 hour postoperative

• Postoperative pain

  The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening.

  at 1 hour postoperative

• Postoperative pain

  The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening.

  at 4 hour postoperative

• Postoperative pain

  The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), has become the most widely used instrument for pain screening.

  at 8 hour postoperative

Secondary Outcomes (10)

• Sedation

  30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.

• Heart rate

  30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.

• Respiratory rate

  30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.

• Temperature

  30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.

• Blood pressure

  30 minutes preoperative, at 0 hour postoperative, at 1 hour postoperative 4, at 8 hour postoperative.

Study Arms (3)

Oxycodone

ACTIVE COMPARATOR

20 mg oxycodone hydrochloride and 10 mg naloxone hydrochloride given as 1 tablet only once, 30 minutes preoperatively.

Drug: Oxycodone 20 Mg Oral Tablet

Pregabalin

ACTIVE COMPARATOR

150 mg Pregabalin given as 1 tablet only once, 30 minutes preoperatively.

Drug: Pregabalin 150mg

Multivitamin

PLACEBO COMPARATOR

Abecedin Multivitamins\&Minerals given as 1 tablet only once, 30 minutes preoperatively.

Drug: Multivitamin with Minerals

Interventions

Oxycodone 20 Mg Oral Tablet DRUG

Oxycodone is a semi-synthetic, morphine-like opioid alkaloid with analgesic activity. Oxycodone exerts its analgesic activity by binding to the mu-receptors in the central nervous system (CNS), thereby mimicking the effects of endogenous opioids. Binding of the opiate receptor stimulates the exchange of GTP for GDP on the G-protein complex and inhibits adenylate cyclase, thereby preventing cAMP production. Subsequently, the release of nociceptive neurotransmitters, such as substance P, gamma-aminobutyric acid (GABA), dopamine, acetylcholine, and noradrenaline, is inhibited. Oxycodone also inhibits the release of vasopressin, somatostatin, insulin, and glucagon. In addition, oxycodone closes N-type voltage-gated calcium channels and opens G-protein-coupled inwardly rectifying potassium channels resulting in hyperpolarization and reduction of neuronal excitability.

Also known as: Targin

Oxycodone

Pregabalin 150mg DRUG

Pregabalin is a gabapentinoid and acts by inhibiting certain calcium channels. Specifically it is a ligand of the auxiliary α2δ subunit site of certain voltage-dependent calcium channels (VDCCs), and thereby acts as an inhibitor of α2δ subunit-containing VDCCs. There are two drug-binding α2δ subunits, α2δ-1 and α2δ-2, and pregabalin shows similar affinity for (and hence lack of selectivity between) these two sites. Pregabalin is selective in its binding to the α2δ VDCC subunit. Despite the fact that pregabalin is a GABA analogue. r synthesizing GABA, and hence may have some indirect GABAergic effects by increasing GABA levels in the brain. In accordance, inhibition of α2δ-1-containing VDCCs by pregabalin appears to be responsible for its anticonvulsant, analgesic, and anxiolytic effects.

Also known as: Lyrica

Pregabalin

Multivitamin with Minerals DRUG

Vit A 3000 IU, Vit B1 2.5mg, Vit B2 2.0mg, Vit B12 10mcg, Vit C 150mg, Vit D3 400 IU, Vit E10 IU, Biotin 25mcg, Nicotimamide 30mg, Calcium Pantothenate 3mg, Folic acid 800mcg, Iron Fumarate 18mg, Calcium 125mg, Magnesium Oxide 10mg, Iodine Potassium 150mcg, Manganese sulfate 0.5mg, Phosphorus 23.8mg, Copper sulfate 1.0mg, Molybdinium Sodium 0.10mg, Zinc Sulfate 5.0mg.

Also known as: Abecedin

Multivitamin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18-year-old.
• Patients undergoing elective surgeries under general anesthesia.
• American Society of Anesthesiology grade 1 or 2.
• BMI 18-35 Kg/m2
• Reliable participant (he/she can give history by him/herself)

You may not qualify if:

• Current Pregnancy or breastfeeding.
• Chronic use of analgesia (use of any analgesic drug for most days in the last three months).
• Current use of analgesia (within last 24 hours).
• Allergy to any medication used in the study.
• Smoking or Nargila use within last 24 hour before surgery and until discharge.
• History of psychiatric medication or disease.
• Discharge from hospital within 6 hours after surgery.
• Participants transferred from the ward to ICU or other wards.
• Known case of liver or kidney impairment.
• History of alcohol use or illicit drug.
• Any complication during surgery leads to changes in protocol of the study.

Sponsors & Collaborators

• An-Najah National University: lead

Study Sites (1)

An-Najah National University Hospital

Nablus, Wes-Bank, 7704, Palestinian Territories

Location

MeSH Terms

Interventions

Oxycodone; Tablets; Pregabalin; Geritol; Minerals

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Inorganic Chemicals

Study Officials

• Zaher Nazzal

  An-Najah National University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: May 25, 2022
• Study Start: August 15, 2021
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

PA (1)