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Clinical Trials/NCT02660632
NCT02660632
Completed
Not Applicable

Effect of Thoracic Epidural Analgesia vs Rectus Sheath Catheters on Postoperative Pulmonary Function After Midline Laparotomy: A Prospective Randomized Controlled Study

Mansoura University1 site in 1 country100 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Surgeries
Sponsor
Mansoura University
Enrollment
100
Locations
1
Primary Endpoint
Changes in forced expiratory volume in 1 second (FEV1)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Pulmonary complications are among the most important postoperative complications after midline incisions, for which different analgesic modalities have been tried.

Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery owing to the proved superior analgesia, reduction of opioid related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility However, it is not without complications.

Rectus sheath block provides several advantages over epidural anesthesia. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for somatic analgesia after major abdominal surgeries. Although patients with rectus sheath block may experience some visceral pain, it is usually minimal by 24 hours after surgery.

Detailed Description

The aim of this study is to compare the effects of thoracic epidural analgesia and rectus sheath blockade on postoperative pulmonary functions, pain scores, duration of analgesia, sedation scores, patients' satisfaction and adverse effects. FEV1, FEV1/FVC ratio will be measured by a bed side spirometer. * Induction of anesthesia: propofol 1.5-2.5 mg kg-1. * Muscle Relaxants: rocuronium 0.6 mg kg-1 for induction. * Maintenance: Sevoflurane 0.7-1.5 MAC vaporized in air-oxygen (40% inspired fraction). Radial artery catheterization: under complete aseptic conditions 20G cannula will be inserted into the radial artery of non-dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2% . Thoracic epidural catheter will be inserted before induction of general anaesthesia under aseptic insertion conditions and using loss of resistance to air technique with the patient in the sitting position at T9- T11 interspaces. The Rectus sheath catheters will be inserted bilaterally using ultrasound (SonoSite M-Turbo®, Sonosite , USA) guidance as described by Webster after induction of general anaesthesia.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
May 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists physical class I to III.
  • Patients scheduled for elective midline laparotomy.

Exclusion Criteria

  • Morbid obese patients.
  • Severe or uncompensated cardiovascular disease.
  • Significant renal disease.
  • Significant hepatic disease.
  • Pregnancy.
  • Lactating.
  • Allergy to the study medications.
  • Psychological disorder.
  • Neurological disorder.
  • Communication barrier.

Outcomes

Primary Outcomes

Changes in forced expiratory volume in 1 second (FEV1)

Time Frame: Before and for 72 hours after surgery

Changes in ratio between forced expiratory volume in 1 s and forced vital capacity (FEV1/FVC)

Time Frame: Before and for 72 hours after surgery

Secondary Outcomes

  • Cumulative tramadol use(For 48 hours after surgery)
  • Postoperative wound infection(For 21 days after surgery)
  • Changes in arterial blood gases(Before and for 72 hours after surgery)
  • Postoperative nausea and vomiting(for 48 hours after surgery)
  • Time to hospital discharge(for 15 days after surgery)
  • Intraoperative use of ephedrine(For 5 hours after induction of anesthesia)
  • Sedation score(for 48 hours after surgery)
  • Return of bowel function(for 72 hours after surgery)
  • Visual analog pain scores(for 48 hours after surgery)
  • Overall patient's satisfaction(For 48 hours after surgery)
  • Postoperative cardio-respiratory complications(For 7 days after surgery)

Study Sites (1)

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