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Completed

NCT Number: NCT02577809

Intrathecal Opioid Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Rahima Moosa Mother and Child Hospital

Johannesburg, Gauteng, 2000, South Africa

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine100

Drug

100mcg added to the spinal anaesthetic

Other names: Morphine 100 mcg

Morphine50

Drug

50mcg added to the spinal anaesthetic

Other names: Morphine 50mcg

Fentanyl

Drug

25mcg Fentanyl added to the spinal anaesthetic

Other names: Fentanyl 25mcg

Hyperbaric Bupivicaine

Drug

1.8ml 0.5% spinal bupivicaine with dextrose

Other names: Spinal Bupivicaine

Indomethacin

Drug

100mg Indomethacin suppository

Other names: Indomethacin Suppository

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Witwatersrand, South Africa

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2015
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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