Intrathecal Opioid Study

University of Witwatersrand

Status and phase: Completed; Phase 4

Conditions: Post-operative Pain

Treatments: Drug: Hyperbaric Bupivicaine; Drug: Morphine50; Drug: Fentanyl; Drug: Morphine100; Drug: Indomethacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02577809

M141181

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

Morphine100

Active Comparator group

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

Treatment:

Drug: Indomethacin

Drug: Morphine100

Drug: Hyperbaric Bupivicaine

Morphine50

Active Comparator group

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

Treatment:

Drug: Indomethacin

Drug: Morphine50

Drug: Hyperbaric Bupivicaine

Fentanyl25

Active Comparator group

Description:

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

Treatment:

Drug: Indomethacin

Drug: Fentanyl

Drug: Hyperbaric Bupivicaine