Intrathecal Morphine for Inguinal Hernia Repair.

Phase 4

Completed

• Conditions: Pruritus; Inguinal Hernia; Nausea; Postoperative Pain; Vomiting
• Interventions: Drug: intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg; Drug: intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg; Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland; Drug: intravenous cannulation and premedication

• Registration Number: NCT02001948
• Lead Sponsor: Ankara University

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2013-11
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-29
• Last Update Submitted: 2013-11-29
• Study First Posted: 2013-12-05
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrathecal morphine 0.1 mg	intravenous cannulation and premedication	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
0.4 mg of intrathecal morphine	intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg	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.
0.4 mg of intrathecal morphine	standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland	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.
intrathecal morphine 0.1 mg	intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg	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
intrathecal morphine 0.1 mg	standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland	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
0.4 mg of intrathecal morphine	intravenous cannulation and premedication	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.

Primary Outcome Measures

Name	Time	Method
Sensory and motor block	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 Outcome Measures

Name	Time	Method
first mobilisation, first urination and first analgesic times	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.

Trial Locations

Locations (1)

Ankara University Faculty of Medicine, Ibni Sina Hospital general surgery OR; 🇹🇷 Ankara, Turkey