Epidural Block vs. Rectus Sheath Block on Postoperative Pulmonary Function

NCT02660632 | Completed DMC

• 1 other identifier: R ∕ 15.12.48
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Surgeries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Changes in arterial blood gases

  Before and for 72 hours after surgery

• Visual analog pain scores

  for 48 hours after surgery

• Sedation score

  for 48 hours after surgery

• Postoperative nausea and vomiting

  for 48 hours after surgery

• Return of bowel function

  for 72 hours after surgery

Study Arms (2)

Thoracic epidural analgesia (TEA)

PLACEBO COMPARATOR

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)

Rectus sheath catheter block

ACTIVE COMPARATOR

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

Interventions

Thoracic epidural analgesia (TEA) 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

Thoracic epidural analgesia (TEA)

Rectus sheath catheter block 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.

Rectus sheath catheter block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Samah Elkenany, MD

  Lecturer of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2016
• First Posted: January 21, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

EG (1)