Intrathecal Opioid Study

An Investigation of the Influence of Different Intrathecal Opioids on the Post-operative Pain Experiences of Woman at Rahima Moosa Mother and Child Hospital

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Morphine100; Drug: Hyperbaric Bupivicaine; Drug: Indomethacin; Drug: Morphine50; Drug: Fentanyl

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2000
      • Rahima Moosa Mother and Child Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Morphine 100 mcg; Drug: Hyperbaric Bupivicaine; 1.8ml 0.5% spinal bupivicaine with dextrose; Other Names: Spinal Bupivicaine; Drug: Indomethacin; 100mg Indomethacin suppository; Other Names: 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: Hyperbaric Bupivicaine; 1.8ml 0.5% spinal bupivicaine with dextrose; Other Names: Spinal Bupivicaine; Drug: Indomethacin; 100mg Indomethacin suppository; Other Names: Indomethacin Suppository; Drug: Morphine50; 50mcg added to the spinal anaesthetic; Other Names: Morphine 50mcg
Active Comparator: Fentanyl25; 1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space	Drug: Hyperbaric Bupivicaine; 1.8ml 0.5% spinal bupivicaine with dextrose; Other Names: Spinal Bupivicaine; Drug: Indomethacin; 100mg Indomethacin suppository; Other Names: Indomethacin Suppository; Drug: Fentanyl; 25mcg Fentanyl added to the spinal anaesthetic; Other Names: Fentanyl 25mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Collaborators and Investigators

• Sponsor: University of Witwatersrand, South Africa
• Investigators: Principal Investigator: Sean Chetty, FCA(SA), University of Witwatersrand, South Africa

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 10, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Fentanyl; Bupivacaine; Morphine; Indomethacin
• Other Study ID Numbers: M141181