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Intrathecal Opioid Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577809
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Sean Chetty, University of Witwatersrand, South Africa

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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: Morphine100 Drug: Morphine50 Drug: Fentanyl Drug: Hyperbaric Bupivicaine Drug: Indomethacin Phase 4

Detailed Description:
  1. To evaluate the effect of three different intrathecal opioid mixtures on post-operative pain experiences in women who have undergone caesarean section surgery, relating specifically to:

    1. Post-operative analgesic requirements at two time points (12 hours and 24 hours) after surgery
    2. Pain scores at two time points (12 hours and 24 hours) after surgery
    3. Sedation scores at two time points (12 hours and 24 hours) after surgery
    4. Post-operative nausea scores at two time points (12 hours and 24 hours) after surgery
    5. Post-operative pruritis scores at two time points (12 hours and 24 hours) after surgery
  2. To determine the impact that the patients' post-operative pain has on their activities in the first 24 hours after surgery

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Investigation of the Influence of Different Intrathecal Opioids on the Post-operative Pain Experiences of Woman at Rahima Moosa Mother and Child Hospital
Study Start Date : July 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Active Comparator: Morphine100
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
100mcg added to the spinal anaesthetic
Other Name: Morphine 100 mcg

Drug: Hyperbaric Bupivicaine
1.8ml 0.5% spinal bupivicaine with dextrose
Other Name: Spinal Bupivicaine

Drug: Indomethacin
100mg Indomethacin suppository
Other Name: Indomethacin Suppository

Active Comparator: Morphine50
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
50mcg added to the spinal anaesthetic
Other Name: Morphine 50mcg

Drug: Hyperbaric Bupivicaine
1.8ml 0.5% spinal bupivicaine with dextrose
Other Name: Spinal Bupivicaine

Drug: Indomethacin
100mg Indomethacin suppository
Other Name: Indomethacin Suppository

Active Comparator: Fentanyl25
1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space
Drug: Fentanyl
25mcg Fentanyl added to the spinal anaesthetic
Other Name: Fentanyl 25mcg

Drug: Hyperbaric Bupivicaine
1.8ml 0.5% spinal bupivicaine with dextrose
Other Name: Spinal Bupivicaine

Drug: Indomethacin
100mg Indomethacin suppository
Other Name: Indomethacin Suppository




Primary Outcome Measures :
  1. Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump [ Time Frame: For 24 hours after surgery ]
    The total administered morphine dose administered to the patient through the PCA pump will be documented. This is documented at 24 hours after surgery.

  2. Patient Pain Score measured by the Numeric Pain Rating scale [ Time Frame: 24 hours after surgery ]
    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.

  3. Patient sedation scores measured by a 4 point sedation scale [ Time Frame: 24 hours ]
    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.

  4. Patient post-operative nausea and vomiting score using a 4 point scale [ Time Frame: 24 hours ]
    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.

  5. Patient post-operative pruritis Score using a 2 point scale [ Time Frame: 24 hours ]
    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.

  6. Patient respiratory rate measured by counting the respiratory rate over a one minute period [ Time Frame: 24 hours ]
    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.


Secondary Outcome Measures :
  1. The Impact of the patients pain on their activity measured using an 11 point scale [ Time Frame: 24 hours ]
    The instrument consists of 11 numbered points ( 0 to 10) each of which represent a different levels of interference with the patients activity since surgery. The scale ranges from 0= DID NOT INTERFERE up to 10= COMPLETELY INTERFERED. This is assessed at 24 hours after surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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:

    1. Patients who have babies that require additional care, for a prolonged period, after birth eg. Neonatal ICU admission for ≥ 12hours or congenital abnormalities
    2. Patients who require ICU or High care admission postoperatively for any intra-operative complications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577809


Locations
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South Africa
Rahima Moosa Mother and Child Hospital
Johannesburg, Gauteng, South Africa, 2000
Sponsors and Collaborators
University of Witwatersrand, South Africa
Investigators
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Principal Investigator: Sean Chetty, FCA(SA) University of Witwatersrand, South Africa
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Responsible Party: Sean Chetty, Senior Clinical Lecturer, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT02577809    
Other Study ID Numbers: M141181
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Indomethacin
Fentanyl
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors