Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia

NCT ID: NCT05389813

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2024-05-01

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)

Detailed Description

• After signing the informed consent, each participant will undergo standard care for any surgical patient (general examination, vital signs recording, history taking, and cannula insertion). Then, a nurse will teach him\her how to use the NRS for pain scores.
• Patients will be randomly allocated by computer-generated list to Group A (oxycodone 20 mg orally), Group B (pregabalin 150 mg orally), or Group C (multivitamins pill orally).
• The medication will be given 30 minutes before operation by an anesthesiology resident who is not aware of the study design in a closed envelope with a code similar to the file code of the participant and he will make sure that the participant ingests the pill with a sip of water and get rid of the envelope immediately.
• The participant then will be transferred to the preparation room before surgery, baseline scores will be recorded for the following parameter: pain scale (NRS) during rest and movement, Modified Ramsay Sedation Score (MRSS), and vital signs.
• Patient then will be transferred to the operation room, and induction of anaesthesia will begin.

The anaesthetic protocol will be standardized.

• The anaesthetists will record the duration of surgery as the time between induction of anaesthesia and arrival to Post-Anesthetic Care Unit (PACU). Arrival to PACU will be recorded as 0 times.
• The participant will be sent to the ward after collecting 8 points or greater or return to baseline on Post-Anesthesia Recovery Score (PARS). Time in PACU will be reported.
• A postoperative patient evaluation will be performed by an anaesthetist who will be unaware of the study design.
• Postoperative pain treatment will be with patient-controlled IV morphine 2.5 mg bolus (rescue analgesia). Nausea will be treated with ondansetron.
• Morphine consumption, pain intensity at rest and during mobilization, nausea and vomiting, sedation, dizziness, and consumption of ondansetron will be recorded at 0, 1, 4, and 8 h after operation.
• On discharge, time and date of discharge and satisfaction of analgesia score will be recorded.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Oxycodone

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

Group Type: ACTIVE_COMPARATOR

Oxycodone 20 Mg Oral Tablet

Intervention Type: 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.

Pregabalin

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

Group Type: ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type: 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.

Multivitamin

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

Group Type: PLACEBO_COMPARATOR

Multivitamin with Minerals

Intervention Type: 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.

Interventions

Oxycodone 20 Mg Oral Tablet

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.

Intervention Type: DRUG

Pregabalin 150mg

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.

Intervention Type: DRUG

Multivitamin with Minerals

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.

Intervention Type: DRUG

Other Intervention Names

Targin; Lyrica; Abecedin

Eligibility Criteria

Inclusion Criteria

1. Age > 18-year-old.

2. Patients undergoing elective surgeries under general anesthesia.

3. American Society of Anesthesiology grade 1 or 2.

4. BMI 18-35 Kg/m2

5. Reliable participant (he/she can give history by him/herself)

Exclusion Criteria

1. Current Pregnancy or breastfeeding.

2. Chronic use of analgesia (use of any analgesic drug for most days in the last three months).

3. Current use of analgesia (within last 24 hours).

4. Allergy to any medication used in the study.

5. Smoking or Nargila use within last 24 hour before surgery and until discharge.

6. History of psychiatric medication or disease.

7. Discharge from hospital within 6 hours after surgery.

8. Participants transferred from the ward to ICU or other wards.

9. Known case of liver or kidney impairment.

10. History of alcohol use or illicit drug.

11. Any complication during surgery leads to changes in protocol of the study.

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

Sponsors

An-Najah National University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zaher Nazzal

Role: STUDY_DIRECTOR

An-Najah National University

Locations

An-Najah National University Hospital

Nablus, Wes-Bank, Palestinian Territories

Countries

Palestinian Territories

Other Identifiers

Preemptive Analgesia

Identifier Type: -

Identifier Source: org_study_id