Intrathecal Morphine for Inguinal Hernia Repair.

Phase 4CompletedNCT02001948

Ankara University46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Inguinal Hernia Nausea Vomiting Pruritus Postoperative Pain

Interventions

intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mgDRUG

intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mgDRUG

standard monitoring with Datex Ohmeda anesthesia monitor, GE, FinlandDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Sensory and motor block

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.

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.

Secondary Outcomes

first mobilisation, first urination and first analgesic times

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

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

Data from ClinicalTrials.gov

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