Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery

Lower Abdominal Oncologic Surgery Clinical Trial

Official title:

Epidural Steroids Combined With Intrathecal Nalbuphine: Analgesic and Side Effects Concept in Lower Abdominal Surgical Oncology Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276325
• Other study ID #: R/17.04.127
• Status: Completed
• Phase: N/A
• First received: September 6, 2017
• Last updated: January 7, 2018
• Start date: September 15, 2017
• Est. completion date: January 7, 2018

Study information

• Verified date: January 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine & IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8 mg nalbuphine compared with (IT) 0.4 mg nalbuphine.

Description:

So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg with the addition of epidural dexamethasone could augment the postoperative analgesia and reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably more effective than lower doses to control moderate to severe post-operative pain. Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated blood glucose level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 7, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Abdominal Oncologic Surgery

Intervention

Drug:
• Placebo-nalbuphine
Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
• Dexamethasone-nalbuphine
Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%

Locations

Country	Name	City	State
Egypt	Mansoura University, Faculty of Medicine	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Pain visual analog score (0: no pain, 100: worst imaginable pain)	For 24 hours after surgery
Secondary	Nausea and vomiting	(0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting)	For 24 hours after surgery
Secondary	Sensory recovery	Regression to S1 spinal segment as tested with cold sensation	For 5 hours after induction of anaesthesia
Secondary	Motor recovery	The time until decreased a modified Bromage score of 0 (i.e. full leg movement)	For 5 hours after induction of anaesthesia
Secondary	First analgesic request	Time to first request of rescue analgesic	For 12 hours after induction of anaesthesia
Secondary	Intraoperative heart rate changes	Changes in heart rate during surgery	For 3 hours after induction of anaesthesia
Secondary	Intraoperative mean arterial blood pressure changes	Changes in mean arterial blood pressure during surgery	For 3 hours after induction of anaesthesia
Secondary	Postoperative heart rate changes	Changes in heart rate after surgery	For 24 hours after surgery
Secondary	Postoperative mean arterial blood pressure changes	Changes in mean arterial blood pressure after surgery	For 24 hours after surgery
Secondary	Cumulative use of antiemetic	Cumulative use of metoclopramide and ondansetron after surgery	for 24 hrs after surgery
Secondary	Cumulative use of rescue intravenous ketorolac	Rescue use of ketorolac in case of severe pain conditions	for 24 hrs after surgery
Secondary	Cumulative use of rescue intravenous nalbuphine	Rescue use of nalbuphine in case of severe pain conditions	For 24 hours after surgery