Intrathecal Morphine for Inguinal Hernia Repair.

Ankara University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Vomiting; Nausea; Inguinal Hernia; Pruritus

Treatments: Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland; Drug: intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg; Drug: intravenous cannulation and premedication; Drug: intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02001948

11-02-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

intrathecal morphine 0.1 mg

Active Comparator group

Description:

After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive a spinal anaesthesia with 0.1 mg morphine combined with 7.5 mg heavy bupivacaine

Treatment:

Drug: intravenous cannulation and premedication

Drug: intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg

Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland

0.4 mg of intrathecal morphine

Active Comparator group

Description:

After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive spinal anesthesia with 0.4 mg of morphine combined with 7.5 mg of heavy bupivacaine.

Treatment:

Drug: intravenous cannulation and premedication

Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland

Drug: intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg