Intrathecal Morphine for Inguinal Hernia Repair.

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001948
• Other study ID #: 11-02-09
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2013
• Last updated: November 29, 2013
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2013
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

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

Device:
• standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland
electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure

Drug:
• intravenous 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

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine, Ibni Sina Hospital general surgery OR	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative nausea, vomiting and pruritus	All patients will be followed up for the first postoperative 24 hours to determine the nausea, vomiting and pruritus incidences.	after the procedure, during the first 24 hours	No
Primary	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.	No
Secondary	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.	after the procedure, during the first 24 hours	No