Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03276325
• Date of registration: 06/09/2017
• Prospective Registration: Yes
• Primary sponsor: Mansoura University
• Public title: Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery
• Scientific title: Epidural Steroids Combined With Intrathecal Nalbuphine: Analgesic and Side Effects Concept in Lower Abdominal Surgical Oncology Procedures
• Date of first enrolment: September 15, 2017
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03276325
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Care Provider, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Egypt

Contacts

• Name: Mohamed A Ghanem, MD
• Affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care

Key inclusion & exclusion criteria

Inclusion Criteria:

- American Society of Anesthesiologists physical class I or II.

- Undergoing laparotomy

- Undergoing oophorectomy

- Undergoing hysterectomy

- Undergoing rectal mass excision

Exclusion Criteria:

- Patient refusal.

- Hypersensitivity to amide local anesthetics.

- General contraindications to spinal anesthesia.

- Cardiac diseases.

- Hepatic failure.

- Renal failure.

- Respiratory failure.

- Communication barriers.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lower Abdominal Oncologic Surgery

Intervention(s)

Drug: Placebo-nalbuphine

Drug: Dexamethasone-nalbuphine

Primary Outcome(s)

Pain score [Time Frame: For 24 hours after surgery]

Secondary Outcome(s)

Motor recovery [Time Frame: For 5 hours after induction of anaesthesia]

Nausea and vomiting [Time Frame: For 24 hours after surgery]

Sensory recovery [Time Frame: For 5 hours after induction of anaesthesia]

Cumulative use of rescue intravenous ketorolac [Time Frame: for 24 hrs after surgery]

Postoperative heart rate changes [Time Frame: For 24 hours after surgery]

Cumulative use of rescue intravenous nalbuphine [Time Frame: For 24 hours after surgery]

Cumulative use of antiemetic [Time Frame: for 24 hrs after surgery]

First analgesic request [Time Frame: For 12 hours after induction of anaesthesia]

Intraoperative heart rate changes [Time Frame: For 3 hours after induction of anaesthesia]

Intraoperative mean arterial blood pressure changes [Time Frame: For 3 hours after induction of anaesthesia]

Postoperative mean arterial blood pressure changes [Time Frame: For 24 hours after surgery]

Secondary ID(s)

R/17.04.127

Source(s) of Monetary Support

Please refer to primary and secondary sponsors