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NCT Number: NCT05303311

Intrathecal Pethidine Plus Dexamethasone for Distal Lower Orthopedic Surgeries

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine , Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

About this study

pethidine compared favorably with bupivacaine as the sole anesthetic agent, providing excellent conditions for lower abdominal and pelvic surgery. Some studies showed that intrathecal pethidine has short motor recovery and prolonged postoperative analgesia in comparison to intrathecal bupivacaine. The side effects of pethidine in spinal anesthesia are pruritus nausea, vomiting and respiratory depression. A dose of 1mg/kg intrathecal pethidine provides surgical anesthesia .However, its effects are not widely available in recent studies.

Dexamethasone is used as an adjuvant to local anesthetic during spinal anesthesia and other techniques of regional anesthesia, it reduces pain and prolongs the duration of post-operative analgesia. It was shown that intrathecal dexamethasone reduces the complications of spinal anesthesia such as arterial hypotension, nausea, vomiting and shivering. The investigators suppose that addition of intrathecal dexamethasone to pethidine may be a better alternative to intrathecal bupivacaine during spinal anesthesia for lower extremity orthopedic surgery with better outcome and less side effects

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Bupivacaine Hydrochloride

Drug

intrathecal injection of bupivacaine alone

Other names: Heavy marcaine

Pethidine plus Dexamethasone

Drug

Intrathecal injection of pethidine plus dexamethasone

Other names: meperidine and decadron

Primary outcomes

  1. The Time of the first need for Rescue Analgesia

    Time frame: 24 hours postoperative

    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.

Secondary outcomes

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

    Time frame: duration of the procedure

    The incidence of hypotension "defined as the mean arterial blood pressure decreased by > 20 % from its value before intrathecal injection of the study drugs"

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

    Time frame: duration of the procedure

    bradycardia "defined as the reduction of heart rate by > 20% of the basal reading".

  3. The onset of the sensory block

    Time frame: duration of the procedure

    The sensory level was checked using the pinprick technique every min for 10 min then at 2-min intervals until a constant block was obtained

  4. The onset of the motor block

    Time frame: duration of the procedure

    The Motor Block was checked using Modified Bromage Score "Bromage 0 means full movement of the hip, knee, and ankle, Bromage 1 means loss of the ability to raise the leg against gravity but able to bend the knee and the ankle joints, Bromage 2 lost the ability to flex the hip and knee joints but preserved flexion of the ankle, Bromage 3 lost the ability to flex the hip, knee, and ankle joints but preserved movement of the toes, Bromage 4 indicates full paralysis of the legs". every min for 10 min then at 2-min intervals until a Bromage score 4 was obtained

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

    Time frame: Up to 12 hours postoperative

    The sensory level was checked using the pinprick technique every 15 min until sensations were gained back to the 5th lumbar dermatome

  6. The time of regression of motor block to full motor function "Bromage score 0".

    Time frame: Up to 12 hours postoperative

    The Motor Block was checked using Modified Bromage Score every 15 min until full motor function was restored. "Bromage score 0"......

    Modified Bromage Score: "Bromage 0 means full movement of the hip, knee, and ankle, Bromage 1 means loss of the ability to raise the leg against gravity but able to bend the knee and the ankle joints, Bromage 2 lost the ability to flex the hip and knee joints but preserved flexion of the ankle, Bromage 3 lost the ability to flex the hip, knee, and ankle joints but preserved movement of the toes, Bromage 4 indicates full paralysis of the legs".

  7. The incidence of perioperative adverse events

    Time frame: duration of the procedure and 24 hours postoperative

    Assess the frequency of perioperative nausea, vomiting, sedation, shivering, pruritis, and respiratory depression.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Comparing the Analgesic Properties of Intrathecal Pethidine Plus Dexamethasone Versus Intrathecal Bupivacaine Alone for Distal Lower Extremity Orthopedic Surgeries: A Randomized Comparative Study.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Jul 30, 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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