Clinical trial NCT02577809: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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

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:

  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

Primary outcomes:
measure: Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump
timeFrame: For 24 hours after surgery
measure: Patient Pain Score measured by the Numeric Pain Rating scale
timeFrame: 24 hours after surgery
measure: Patient sedation scores measured by a 4 point sedation scale
timeFrame: 24 hours
measure: Patient post-operative nausea and vomiting score using a 4 point scale
timeFrame: 24 hours
measure: Patient post-operative pruritis Score using a 2 point scale
timeFrame: 24 hours
measure: Patient respiratory rate measured by counting the respiratory rate over a one minute period
timeFrame: 24 hours
Secondary outcomes:
measure: The Impact of the patients pain on their activity measured using an 11 point scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Rahima Moosa Mother and Child Hospital
state: Gauteng
Study officials:
affiliation: University of Witwatersrand, South Africa
name: Sean Chetty, FCA(SA)
role: PRINCIPAL_INVESTIGATOR
References: