Intrathecal Opioid Study

NCT02577809 | Completed Phase 4

• 1 other identifier: M141181
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional drug trail to evaluate the effect of different intrathecal opioids on post-operative pain experiences in women who have undergone caesarean section surgery.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (6)

• Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump

  The total administered morphine dose administered to the patient through the PCA pump will be documented. This is documented at 24 hours after surgery.

  For 24 hours after surgery

• Patient Pain Score measured by the Numeric Pain Rating scale

  The instrument consists of 11 numbered points ( 0 to 10) each of which represent a different pain level for the patient. The scale ranges from 0=NO PAIN up to 10= worst pain possible. This is assessed at 24 hours after surgery.

  24 hours after surgery

• Patient sedation scores measured by a 4 point sedation scale

  The instrument consists of 4 numbered points ( 0 to 3) each of which represent a different level of sedation for the patient. The scale ranges as follows: 0 =awake, 1 = mild drowsiness, 2 = moderate drowsiness, easily awaken, 3 =difficult to arouse.This is assessed at 24 hours after surgery.

  24 hours

• Patient post-operative nausea and vomiting score using a 4 point scale

  The instrument consists of 4 numbered points ( 0 to 3) each of which represent a different level of nausea for the patient. The scale ranges as follows: 0 = No Nausea, 1 = presence of nausea without vomiting, 2 = mild to moderate vomiting (not requiring treatment), 3 = severe vomiting (treatment required). This is assessed at 24 hours after surgery.

  24 hours

• Patient post-operative pruritis Score using a 2 point scale

  The instrument consists of 3 numbered points ( 0 to 2) each of which represent a different level of pruritus for the patient. The scale ranges as follows: 0 = no pruritus, 1 = mild to moderate pruritus (not requiring treatment), 2 = severe pruritus (treatment required). This is assessed at 24 hours after surgery.

  24 hours

• Patient respiratory rate measured by counting the respiratory rate over a one minute period

  The patients respiratory rate will be counted by the investigator at the time of evaluation at 24hours after surgery. The resulted will be documented as a rate per minute.

  24 hours

Secondary Outcomes (1)

• The Impact of the patients pain on their activity measured using an 11 point scale

  24 hours

Study Arms (3)

Morphine100

ACTIVE COMPARATOR

1.8ml 0.5% hyperbaric bupivacaine with 0.1mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space

Drug: Morphine100; Drug: Hyperbaric Bupivicaine; Drug: Indomethacin

Morphine50

ACTIVE COMPARATOR

1.8ml 0.5% hyperbaric bupivacaine with 0.05mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space

Drug: Morphine50; Drug: Hyperbaric Bupivicaine; Drug: Indomethacin

Fentanyl25

ACTIVE COMPARATOR

1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space

Drug: Fentanyl; Drug: Hyperbaric Bupivicaine; Drug: Indomethacin

Interventions

Morphine100 DRUG

100mcg added to the spinal anaesthetic

Also known as: Morphine 100 mcg

Morphine100

Morphine50 DRUG

50mcg added to the spinal anaesthetic

Also known as: Morphine 50mcg

Morphine50

Fentanyl DRUG

25mcg Fentanyl added to the spinal anaesthetic

Also known as: Fentanyl 25mcg

Fentanyl25

Hyperbaric Bupivicaine DRUG

1.8ml 0.5% spinal bupivicaine with dextrose

Also known as: Spinal Bupivicaine

Fentanyl25; Morphine100; Morphine50

Indomethacin DRUG

100mg Indomethacin suppository

Also known as: Indomethacin Suppository

Fentanyl25; Morphine100; Morphine50

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients \> 18years having caesarean section surgery under single shot spinal neuraxial anaesthesia at Rahima Moosa Mother and Child Hospital

You may not qualify if:

• Pre-operative:
• b) Patient refusal or inability to give informed consent c) Severe pre-eclampsia d) Eclampsia e) Patient unable to understand how to use the Patient Controlled Analgesia (PCA) pump, after appropriate counselling and training
• Intra-operative:
• a) Obstetric Complications: i) Post-partum Haemorrhage ii) Ruptured Uterus iii) Still Birth b) Conversion to general anaesthesia intra-operatively c) Administration of supplementary intravenous opioid analgesics
• Post-operative:
• Patients who have babies that require additional care, for a prolonged period, after birth eg. Neonatal ICU admission for ≥ 12hours or congenital abnormalities
• Patients who require ICU or High care admission postoperatively for any intra-operative complications

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead

Study Sites (1)

Rahima Moosa Mother and Child Hospital

Johannesburg, Gauteng, 2000, South Africa

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; Fentanyl; Indomethacin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Indoles; Heterocyclic Compounds, 2-Ring

Study Officials

• Sean Chetty, FCA(SA)

  University of Witwatersrand, South Africa

  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: Senior Clinical Lecturer

Study Record Dates

• First Submitted: October 10, 2015
• First Posted: October 16, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

ZA (1)