Clinical trial NCT02660632: Epidural Block vs. Rectus Sheath Block on Postoperative Pulmonary Function
Official title: Effect of Thoracic Epidural Analgesia vs Rectus Sheath Catheters on Postoperative Pulmonary Function After Midline Laparotomy: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Surgeries
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.
* Mental disorders.
* Epilepsy.
* FEV1 or FEV1/FVC ratio less than 50%, dyspnea with a New York Heart Association class IV.
* Drug or alcohol abuse.
* Contraindications to epidural anaesthesia.
* Opioid analgesic medication within 24 h before the operation.

Primary outcomes:
measure: Changes in forced expiratory volume in 1 second (FEV1)
timeFrame: Before and for 72 hours after surgery
measure: Changes in ratio between forced expiratory volume in 1 s and forced vital capacity (FEV1/FVC)
timeFrame: Before and for 72 hours after surgery
Secondary outcomes:
measure: Changes in arterial blood gases
timeFrame: Before and for 72 hours after surgery
measure: Visual analog pain scores
timeFrame: for 48 hours after surgery
measure: Sedation score
timeFrame: for 48 hours after surgery
measure: Postoperative nausea and vomiting
timeFrame: for 48 hours after surgery
measure: Return of bowel function
timeFrame: for 72 hours after surgery
measure: Time to hospital discharge
timeFrame: for 15 days after surgery
measure: Cumulative tramadol use
timeFrame: For 48 hours after surgery
measure: Overall patient's satisfaction
timeFrame: For 48 hours after surgery
measure: Intraoperative use of ephedrine
timeFrame: For 5 hours after induction of anesthesia
measure: Postoperative cardio-respiratory complications
timeFrame: For 7 days after surgery
measure: Postoperative wound infection
timeFrame: For 21 days after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university
state: DK
Study officials:
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
name: Samah Elkenany, MD
role: PRINCIPAL_INVESTIGATOR
References: