Epidural Block vs. Rectus Sheath Block on Postoperative Pulmonary Function

NCT ID: NCT02660632

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-05-31

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.

Conditions

Abdominal Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Thoracic epidural analgesia (TEA)

Patients who will be subjected for midline laparotomy, will receive epidural analgesia through an inserted thoracic epidural catheter before induction of general anesthesia

Group Type: PLACEBO_COMPARATOR

Thoracic epidural analgesia (TEA)

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Rectus sheath catheter block

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samah Elkenany, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Anesthesia and Surgical Intensive Care

Locations

Mansoura university

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

R ∕ 15.12.48

Identifier Type: -

Identifier Source: org_study_id