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Intrathecal Morphine for Inguinal Hernia Repair.

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02001948
Enrollment
46
Registered
2013-12-05
Start date
2009-07-31
Completion date
2010-07-31
Last updated
2013-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia, Nausea, Postoperative Pain, Pruritus, Vomiting

Keywords

Spinal anaesthesia, morphine, postoperative analgesia, vomiting

Brief summary

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.

Detailed description

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.

Interventions

DRUGintrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg
DRUGintrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg
DEVICEstandard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland

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

DRUGintravenous cannulation and premedication

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

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensory and motor blockThe 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

MeasureTime frameDescription
first mobilisation, first urination and first analgesic timesafter the procedure, during the first 24 hoursall patients will be followed up during the first postoperative 24 hours to assess the first mobilisation, first voiding and first analgesic requirement times.

Other

MeasureTime frameDescription
postoperative nausea, vomiting and pruritusafter the procedure, during the first 24 hoursAll patients will be followed up for the first postoperative 24 hours to determine the nausea, vomiting and pruritus incidences.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026