Intrathecal Pethidine Plus Dexamethasone for Distal Lower Orthopedic Surgeries

NCT05303311 | Completed Phase 4

• 1 other identifier: 8035-7-11-2021
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Bupivacaine is commonly used as a sole agent for spinal anesthesia unlike pethidine. Pethidine (meperidine) is a unique opioid. In addition to its analgesic activity, it also has significant local anesthetic activity. This property enables it to be used as the sole agent for spinal anesthesia

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The Time of the first need for Rescue Analgesia

  the time from the end of the intrathecal injection of the study drugs to the first report of pain that reached NRS 4 as described by the patient.

  24 hours postoperative

Secondary Outcomes (7)

• Intraoperative changes in the blood pressure measurements (The incidence of hypotension )

  duration of the procedure

• Intraoperative changes in the heart rate measurements (The incidence of bradycardia)

  duration of the procedure

• The onset of the sensory block

  duration of the procedure

• The onset of the motor block

  duration of the procedure

• The time of regression of sensory block to the 5th lumbar dermatome

  Up to 12 hours postoperative

Study Arms (2)

Bupivacaine group

ACTIVE COMPARATOR

Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone.

Drug: Bupivacaine Hydrochloride

pethidine plus dexamethasone group

ACTIVE COMPARATOR

Patients will be anesthetized by spinal anesthesia by intrathecal injection of 1mg/kg preservative-free pethidine plus 4mg dexamethasone diluted to a volume of 3 ml with 0.9% sodium chloride

Drug: Pethidine plus Dexamethasone

Interventions

Bupivacaine Hydrochloride DRUG

intrathecal injection of bupivacaine alone

Also known as: Heavy marcaine

Bupivacaine group

Pethidine plus Dexamethasone DRUG

Intrathecal injection of pethidine plus dexamethasone

Also known as: meperidine and decadron

pethidine plus dexamethasone group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance.
• Patients scheduled for lower extremity orthopedic surgery
• Both sex
• Patient's age \>18 years.
• Patients with American Society of Anaesthesia (ASA)physical status I, II.

You may not qualify if:

• Patient's age ≤18 years.
• Uncooperative patients and patients with psychological problems.
• Patients with contraindications to spinal anesthesia.
• Patients with contraindications to bupivacaine or dexamethasone or pethidine.
• Patients with ASA physical status III and IV.
• Morbid obesity (BMI \>35).

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine , Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Meperidine; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Salwa S ElSherbeny, Lecturer

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Intensive Care and pain management, Faculty of Medicine, Zagazig University

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 31, 2022
• Study Start: January 15, 2022
• Primary Completion: January 15, 2024
• Study Completion: March 15, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (1)