NCT02577809

An Investigation of the Influence of Different Intrathecal Opioids on the Post-operative Pain Experiences of Woman at Rahima Moosa Mother and Child Hospital

Completed Phase 4 Last updated 14 October 2015

What this trial tests

Phase 4 trial testing Morphine100 in Post-operative Pain in 100 participants. Completed in 1 September 2015.

Timeline

1 July 2015

Primary endpoint
1 September 2015

1 September 2015

Quick facts

Lead sponsor	University of Witwatersrand, South Africa
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	1 July 2015
Primary completion	1 September 2015
Estimated completion	1 September 2015
Sites	1 location across South Africa

Drugs / interventions tested

• Morphine100 — full drug profile →
• Morphine50 — full drug profile →
• Fentanyl (fentanyl) — full drug profile →
• Hyperbaric Bupivicaine — full drug profile →
• Indomethacin (INDOMETHACIN) — full drug profile →

Conditions studied

• Post-operative Pain — all drugs for Post-operative Pain →

Sponsor

University of Witwatersrand, South Africa

Who can join

18 and older, female only, with Post-operative Pain. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.