Intrathecal Morphine for Inguinal Hernia Repair.

NCT02001948 | Completed Phase 4

• 1 other identifier: 11-02-09
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Nausea; Vomiting; Pruritus; Postoperative Pain

Keywords

Spinal anaesthesia; morphine; postoperative analgesia; vomiting

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• first mobilisation, first urination and first analgesic times

  after the procedure, during the first 24 hours

Other Outcomes (1)

• postoperative nausea, vomiting and pruritus

  after the procedure, during the first 24 hours

Study Arms (2)

intrathecal morphine 0.1 mg

ACTIVE COMPARATOR

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

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

0.4 mg of intrathecal morphine

ACTIVE COMPARATOR

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.

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

Interventions

intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg DRUG

intrathecal morphine 0.1 mg

intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg DRUG

0.4 mg of intrathecal morphine

standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland DEVICE

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

0.4 mg of intrathecal morphine; intrathecal morphine 0.1 mg

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

0.4 mg of intrathecal morphine; intrathecal morphine 0.1 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

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

Ankara, 06700, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal; Nausea; Vomiting; Pruritus; Pain, Postoperative

Interventions

Premedication

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Basak Ceyda Meco

  Ankara University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DESA

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 5, 2013
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 5, 2013

Record last verified: 2013-11

Locations

TU (1)