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Intrathecal Opioid Study

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Phase 4
Locations
South Africa
Study Type
Interventional
Intervention
Morphine100
Morphine50
Fentanyl
Hyperbaric Bupivicaine
Indomethacin
Sponsored by
University of Witwatersrand, South Africa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rahima Moosa Mother and Child Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Morphine100

Morphine50

Fentanyl25

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2015
Last Updated
October 14, 2015
Sponsor
University of Witwatersrand, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT02577809
Brief Title
Intrathecal Opioid Study
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witwatersrand, South Africa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine100
Arm Type
Active Comparator
Arm Description
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
Arm Title
Morphine50
Arm Type
Active Comparator
Arm Description
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
Arm Title
Fentanyl25
Arm Type
Active Comparator
Arm Description
1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space
Intervention Type
Drug
Intervention Name(s)
Morphine100
Other Intervention Name(s)
Morphine 100 mcg
Intervention Description
100mcg added to the spinal anaesthetic
Intervention Type
Drug
Intervention Name(s)
Morphine50
Other Intervention Name(s)
Morphine 50mcg
Intervention Description
50mcg added to the spinal anaesthetic
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Fentanyl 25mcg
Intervention Description
25mcg Fentanyl added to the spinal anaesthetic
Intervention Type
Drug
Intervention Name(s)
Hyperbaric Bupivicaine
Other Intervention Name(s)
Spinal Bupivicaine
Intervention Description
1.8ml 0.5% spinal bupivicaine with dextrose
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Other Intervention Name(s)
Indomethacin Suppository
Intervention Description
100mg Indomethacin suppository
Primary Outcome Measure Information:
Title
Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump
Description
The total administered morphine dose administered to the patient through the PCA pump will be documented. This is documented at 24 hours after surgery.
Time Frame
For 24 hours after surgery
Title
Patient Pain Score measured by the Numeric Pain Rating scale
Description
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.
Time Frame
24 hours after surgery
Title
Patient sedation scores measured by a 4 point sedation scale
Description
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.
Time Frame
24 hours
Title
Patient post-operative nausea and vomiting score using a 4 point scale
Description
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.
Time Frame
24 hours
Title
Patient post-operative pruritis Score using a 2 point scale
Description
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.
Time Frame
24 hours
Title
Patient respiratory rate measured by counting the respiratory rate over a one minute period
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The Impact of the patients pain on their activity measured using an 11 point scale
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Chetty, FCA(SA)
Organizational Affiliation
University of Witwatersrand, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rahima Moosa Mother and Child Hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2000
Country
South Africa

12. IPD Sharing Statement

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Intrathecal Opioid Study

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