Epidural Block vs. Rectus Sheath Block on Postoperative Pulmonary Function

Study 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.

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

Conditions
-----------------
Abdominal Surgeries

Intervention / Treatment
-----------------
* Other: Thoracic epidural analgesia (TEA)
* Other: Rectus sheath catheter block


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Thoracic epidural analgesia (TEA)<br>Patients who will be subjected for midline laparotomy, will receive epidural analgesia through an inserted thoracic epidural catheter before induction of general anesthesia | Other: Thoracic epidural analgesia (TEA)<br>* Epidural catheter will be inserted at T9-T11. Then, epidural analgesia will be activated with administering bolus of 10 mls 0.25% bupivacaine in conjunction with100 mcg fentanyl to establish a block. This will be followed by an infusion of 0.125% bupivacaine in conjunction with 2 mcg/ ml fentanyl at a rate of 10 mls /hour and then titrated to effect for up to 48 hour postoperative<br>|
| Active Comparator: Rectus sheath catheter block<br>After insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected on each side, then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively. | Other: Rectus sheath catheter block<br>* Following insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected through each one. Then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in forced expiratory volume in 1 second (FEV1) |  | Before and for 72 hours after surgery | 
| Changes in ratio between forced expiratory volume in 1 s and forced vital capacity (FEV1/FVC) |  | Before and for 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in arterial blood gases |  | Before and for 72 hours after surgery | 
| Visual analog pain scores | Postoperative pain will be assessed on rest and with cough and during movements for both of visceral and parietal pain | for 48 hours after surgery | 
| Sedation score | Sedation scores using a sedation scale (awake and alert= 0; quietly awake= 1; asleep but easily roused= 2; deep sleep= 3. | for 48 hours after surgery | 
| Postoperative nausea and vomiting | The degree of nausea and vomiting. Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3). The number of vomiting episodes and the number of anti-emetics received | for 48 hours after surgery | 
| Return of bowel function | The times to first flatus, defecation, intake of clear liquid and solid food tolerance | for 72 hours after surgery | 
| Time to hospital discharge | from the end of anesthesia | for 15 days after surgery | 
| Cumulative tramadol use |  | For 48 hours after surgery | 
| Overall patient's satisfaction | Patient overall satisfaction will be assessed before hospital discharge using the visual analog score | For 48 hours after surgery | 
| Intraoperative use of ephedrine |  | For 5 hours after induction of anesthesia | 
| Postoperative cardio-respiratory complications |  | For 7 days after surgery | 
| Postoperative wound infection |  | For 21 days after surgery |