intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain

Postoperative Pain Clinical Trial

Official title:

Effects of Intrathecally Administered Ketamine, Morphine and Their Combination in Patients Undergoing Major Abdominal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726828
• Other study ID #: 165
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 30, 2016
• Last updated: January 25, 2017
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesia (ASA) I-III patients.

• aged 30-50 years.

• scheduled for major abdominal cancer surgery.

Exclusion Criteria:

• Patients with a known allergy to the study drugs.

• significant cardiac, respiratory, renal or hepatic disease.

• coagulation disorders.

• infection at or near the site of intrathecal injection.

• drug or alcohol abuse.

• BMI > 30 kg/m2.

• psychiatric illnesses that may interfere with perception and assessment of pain.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• intrathecal morphine
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.
• intrathecal ketamine
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.
• intrathecal morphine + ketamine
patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and intrathecal morphine + ketamine 0.3 mg and 0.1 mg/kg respectively in 1 ml volume.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) scores	postoperative pain measured by this score.	24 hours postoperative
Primary	time to first analgesic request	the time passed till the first request of rescue analgesia by the patients	24 hours postoperative
Primary	total analgesic consumption	the total amount of rescue analgesic drug used allover follow up period	24 hours postoperative
Secondary	side effects	the type and rate of incidence of side effects during the follow up period	24 hours postoperative