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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02577809

Enrollment

100

Registered

2015-10-16

Start date

2015-07-31

Completion date

2015-09-30

Last updated

2015-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

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

Interventions

DRUGMorphine100

100mcg added to the spinal anaesthetic

DRUGMorphine50

50mcg added to the spinal anaesthetic

DRUGFentanyl

25mcg Fentanyl added to the spinal anaesthetic

DRUGHyperbaric Bupivicaine

1.8ml 0.5% spinal bupivicaine with dextrose

DRUGIndomethacin

100mg Indomethacin suppository

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Patient sedation scores measured by a 4 point sedation scale	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.
Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump	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.
Patient Pain Score measured by the Numeric Pain Rating scale	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.
Patient respiratory rate measured by counting the respiratory rate over a one minute period	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.
Patient post-operative nausea and vomiting score using a 4 point scale	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.
Patient post-operative pruritis Score using a 2 point scale	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.

Secondary

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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026