Peri-operative Rectus Sheath Block Versus TEA Abdominal Surgeries

NCT03460561 | Completed Phase 3

• 1 other identifier: South Egypt Cancer Institute
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Thoracic epidural analgesia (TEA) can be considered the gold standard for postoperative analgesia in major abdominal surgeries, as proved by a lot of number of systematic reviews and meta-analyses have demonstrated that TEA was associated with superior postoperative analgesia, better patients' outcomes, reducing (systemic opiate requirements, ileus and pulmonary complications). The rectus sheath block (RSB) is effective for the surgeries that necessitated midline abdominal incisions as local anesthetics instillation will be within the posterior rectus sheath bilaterally providing intense analgesia for the middle anterior wall from the xiphoid process to the symphysis pubis in adults.

Conditions

Abdominal Cancer

Keywords

TEA; Rectus sheath block; Major abdominal cancer surgery

Outcome Measures

Primary Outcomes (1)

• assessing a change in VAS score with cough

  assessing a change in Pain severity by VAS score with cough (0-10) 0=no pain 10=worst pain ever

  at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.

Secondary Outcomes (1)

• assessing a change of MAP

  at baseline , 4, 8, 12, 18, 24, 36 and 48 hours post operative.

Study Arms (2)

TEA group

ACTIVE COMPARATOR

peri operative thoracic epidural block (TEA) via fentanyl-levo bupivacaine infusion.

Procedure: Thoracic epidural block (TEA)

RSB group

ACTIVE COMPARATOR

peri operative rectus sheath block (RSB) via fentanyl-levo bupivacaine infusion.

Procedure: Rectus sheath block (RSB)

Interventions

Thoracic epidural block (TEA) PROCEDURE

Under complete aseptic precautions and before induction of GA, thoracic epidural catheter was inserted using a 17 gauge, Tuohy epidural needle by a midline approach. T9-T10 interspace was chosen for the injection after skin infiltration by 5 mL of lidocaine 1%. The epidural space was identified by the loss of resistance technique then the catheter was introduced 2 cm into the epidural space, and epidural test dose of 3 mL of lidocaine 2% with 1:200,000 adrenaline was injected to exclude vascular or subarachnoid position.

Also known as: Thoracic epidural analgesia

TEA group

Rectus sheath block (RSB) PROCEDURE

Under aseptic technique, the rectus muscle was imaged with the ultrasound probe, A broadband (5-12 MHz) linear array probe of Sonosite ™ 3000 ultrasound (FUJIFILM, Sonosite EDGE II -UAS) in a transverse orientation at or immediately above the level of the umbilicus, with an imaging depth of 4-6 cm. Inserting the needle: An 18G Tuohy needle was introduced few millimeters from the probe using an in plane technique in an angle of 45 degrees to the skin. (posterior rectus sheath and fascia transversalis). Under direct vision, the needle tip was advanced to the desired position where 20 mL of (levo-bupivacaine 0.25% Fentanyl 30 μg) were injected causing hydro dissection of the rectus muscle away from the posterior rectus sheath. The technique is repeated on the opposite side.

RSB group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, classified as American Society of Anesthesiologists (ASA) grade II and III, scheduled for elective major abdominal cancer surgery were consecutively enrolled.

You may not qualify if:

• We excluded from the study; patients who refused the study, Patients with coagulopathy, active neurological disease, cutaneous disorders at the epidural insertion site, and who were allergic to the studied medications.

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Asyut, 0020, 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

• Alaa A. Elzohry, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: March 9, 2018
• Study Start: August 1, 2016
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

EG (1)