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Completed

NCT Number: NCT02001948

Intrathecal Morphine for Inguinal Hernia Repair.

The aim of this study was to compare the effects of two different doses of intrathecal morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative block regression times, postoperative analgesia and the severity of side effects, for inguinal hernia repairs.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Pruritus Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara University Faculty of Medicine, Ibni Sina Hospital general surgery OR

Ankara, 06700, Turkey (Türkiye)

About this study

The purpose of this study was to compare spinal anesthesia with low dose heavy bupivacaine combined with 0.1 mg or 0.4 mg of morphine in inguinal hernia repair surgeries. Anesthesia onset time (sensory and motor blocks) as well as postoperative recovery (first mobilisation, first voiding) time were compared. Also the postoperative pain management and side effects (nausea, vomiting and pruritus) were assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anaesthesiology physical status I-II patients
  • aged 18-65 years
  • undergoing elective unilateral open inguinal hernia repair surgery

Exclusion criteria

  • contraindications to spinal anesthesia
  • central or peripheral neuropathies
  • severe respiratory or cardiac diseases
  • chronic analgesic use
  • history of substance abuse
  • allergy to local anesthetics

Treatment and study plan

intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg

Drug

intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg

Drug

standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland

Device

electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure

intravenous cannulation and premedication

Drug

18-gauge intravenous cannula was inserted at the forearm opposite to the surgical side and routine iv premedication (midazolam 0.03 mg/kg) was given

Primary outcomes

  1. Sensory and motor block

    Time frame: The change in motor block and sensory block levels will be assessed after performing spinal block, every 5 minutes for 30 minutes and then at the end of the procedure.

    Sensory and motor block produced by the spinal anaesthesia will be assessed prior the procedure to define readiness for surgery and then once the procedure is over, sensory and motor block levels will be assessed one more time to follow up the block regression times. Motor block will be assessed with Bromage scale (0: no motor block, 1: hip blocked; 2: hip and knee blocked; 3: hip, knee and ankle blocked). Sensory block will be assessed using loss of pinprick sensation. The onset of surgical anesthesia is defined as loss of pinprick sensation at ≥ T10 with a Bromage score ≥ 2.

Secondary outcomes

  1. first mobilisation, first urination and first analgesic times

    Time frame: after the procedure, during the first 24 hours

    all patients will be followed up during the first postoperative 24 hours to assess the first mobilisation, first voiding and first analgesic requirement times.

Other outcomes

  1. postoperative nausea, vomiting and pruritus

    Time frame: after the procedure, during the first 24 hours

    All patients will be followed up for the first postoperative 24 hours to determine the nausea, vomiting and pruritus incidences.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

The Comparison of Two Different Doses of Morphine Added to Spinal Bupivacaine for Inguinal Hernia Repair.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2013
Registry last updated
Dec 5, 2013

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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