Epidural Block vs. Rectus Sheath Block on Postoperative Pulmonary Function

Abdominal Surgeries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660632
• Other study ID #: R / 15.12.48
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2018

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Surgeries

Intervention

Other:
• Thoracic epidural analgesia (TEA)
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
• Rectus sheath catheter block
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.

Locations

Country	Name	City	State
Egypt	Mansoura university	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	Changes in forced expiratory volume in 1 second (FEV1)		Before and for 72 hours after surgery
Primary	Changes in ratio between forced expiratory volume in 1 s and forced vital capacity (FEV1/FVC)		Before and for 72 hours after surgery
Secondary	Changes in arterial blood gases		Before and for 72 hours after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Return of bowel function	The times to first flatus, defecation, intake of clear liquid and solid food tolerance	for 72 hours after surgery
Secondary	Time to hospital discharge	from the end of anesthesia	for 15 days after surgery
Secondary	Cumulative tramadol use		For 48 hours after surgery
Secondary	Overall patient's satisfaction	Patient overall satisfaction will be assessed before hospital discharge using the visual analog score	For 48 hours after surgery
Secondary	Intraoperative use of ephedrine		For 5 hours after induction of anesthesia
Secondary	Postoperative cardio-respiratory complications		For 7 days after surgery
Secondary	Postoperative wound infection		For 21 days after surgery