Intrathecal Opioid Study

Post-operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577809
• Other study ID #: M141181
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2015
• Last updated: October 14, 2015
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Witwatersrand, South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Morphine100
100mcg added to the spinal anaesthetic
• Morphine50
50mcg added to the spinal anaesthetic
• Fentanyl
25mcg Fentanyl added to the spinal anaesthetic
• Hyperbaric Bupivicaine
1.8ml 0.5% spinal bupivicaine with dextrose
• Indomethacin
100mg Indomethacin suppository

Locations

Country	Name	City	State
South Africa	Rahima Moosa Mother and Child Hospital	Johannesburg	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No