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Completed

NCT Number: NCT03276325

Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery

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.

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Key information

Conditions

Lower Abdominal Oncologic Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University, Faculty of Medicine

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo-nalbuphine

Drug

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

Drug

Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%

Primary outcomes

  1. Pain score

    Time frame: For 24 hours after surgery

    Pain visual analog score (0: no pain, 100: worst imaginable pain)

Secondary outcomes

  1. Nausea and vomiting

    Time frame: For 24 hours after surgery

    (0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting)

  2. Sensory recovery

    Time frame: For 5 hours after induction of anaesthesia

    Regression to S1 spinal segment as tested with cold sensation

  3. Motor recovery

    Time frame: For 5 hours after induction of anaesthesia

    The time until decreased a modified Bromage score of 0 (i.e. full leg movement)

  4. First analgesic request

    Time frame: For 12 hours after induction of anaesthesia

    Time to first request of rescue analgesic

  5. Intraoperative heart rate changes

    Time frame: For 3 hours after induction of anaesthesia

    Changes in heart rate during surgery

  6. Intraoperative mean arterial blood pressure changes

    Time frame: For 3 hours after induction of anaesthesia

    Changes in mean arterial blood pressure during surgery

  7. Postoperative heart rate changes

    Time frame: For 24 hours after surgery

    Changes in heart rate after surgery

  8. Postoperative mean arterial blood pressure changes

    Time frame: For 24 hours after surgery

    Changes in mean arterial blood pressure after surgery

  9. Cumulative use of antiemetic

    Time frame: for 24 hrs after surgery

    Cumulative use of metoclopramide and ondansetron after surgery

  10. Cumulative use of rescue intravenous ketorolac

    Time frame: for 24 hrs after surgery

    Rescue use of ketorolac in case of severe pain conditions

  11. Cumulative use of rescue intravenous nalbuphine

    Time frame: For 24 hours after surgery

    Rescue use of nalbuphine in case of severe pain conditions

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 8, 2017
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.