Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery

NCT04434339 | Completed

• 1 other identifier: MS-104-2020
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is one of the greatest patient concerns following any surgery. Although an increased emphasis has been placed on pain management, approximately 80% of surgical patients report postoperative pain with 86% of patients rating their pain as moderate, severe, or extreme. In recent years, the increasing adoption of ultrasound-guided regional anesthesia for acute pain management parallels the rapid rise in the availability of ultrasound machines, facilitating description of a number of important fascial plane blocks blocking the dorsal, lateral and anterior cutaneous nerves of the thorax and abdomen. These new descriptions in blocks are supposed to be an advance in regional anesthesia due to its simplicity and lack of complications. These include the transversus abdominis plane block, rectus sheath block, quadratus lumborum block, pectoralis nerve block, serratus plane block, retrolaminar block, and now the Erector spinae block. Although ESP and TAB blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing ovarian cancer surgery under general anesthesia thus in this randomized controlled study we are aiming to fill this gap in the literature. Hypothesis Analgesia provided by the erector spine plane block is superior to that of transversus abdominis block in patients undergoing ovarian cancer surgery under general anesthesia.

Conditions

Postoperative Pain Management

Keywords

erector spinae; block; pain; transversus; abdominis

Outcome Measures

Primary Outcomes (1)

• postoperative tramadol consumption

  postoperative tramadol consumption in mg

  within 24 hours after surgery

Study Arms (3)

group 1

EXPERIMENTAL

"ESP block group" ,Patients received preoperative US guided ESP block on BOTH sides to be operated upon 30 minutes before being transferred to the OR

Procedure: erector spinae block

group 2

EXPERIMENTAL

"TAB group" ,Patients received bilateral lower TAB 30 min before being transferred to the OR

Procedure: transversus abdominis block

group 3

NO INTERVENTION

"the control group", Patients will not receive any block.

Interventions

erector spinae block PROCEDURE

A volume of 20 ml for each side of erector spinae plane with 0.25% plain bupivacaine

Also known as: erector spinae plane block

group 1

transversus abdominis block PROCEDURE

A volume of 20 ml for each side of transversus abdominis plane with 0.25% plain bupivacaine

Also known as: transversus abdominis plane block

group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female Patients undergoing ovarian cancer surgery under general anesthesia with ASA I-II and Age ≥ 18 and ≤ 65 Years

You may not qualify if:

• Patient refusal.
• uncooperative patients
• Cardiovascular disease in the form of Uncontrolled hypertension, IHD, AF, cardiomyopathy with EF \<50%
• Cerebrovascular insufficiency in the form of TIAs, REND, stroke, cerebral hemorrhage, brain tumour, epilepsy
• Coagulation defects with INR\>1.5 platelets count\< 80000
• hepatic insufficiency with ALT and AST \> twice normal, total bilirubin \>1.5 , PC \< 80%.
• Hypersensitivity to the study drugs.
• Pregnant patients
• patients receiving vasoactive drugs or beta blockers

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

anesthesia department at Cairo University

Cairo, Manial, 11512, Egypt

Location

Related Publications (1)

• 25. .Jiří M.,et al. Postoperative Pain Management. Third updated edition.Mladá fronta a. s., Mezi Vodami 2017.1952/9 26. Tulgar S. et tal Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective,randomized, controlled clinical trial. Journal of Clinical Anesthesia .2018; (49):101-106 27. Canakci, E.et al.The Analgesic Efficacy of Transverse Abdominis Plane Block versus Epidural Block after Caesarean Delivery: Which One Is Effective? TAP Block? Epidural Block?." Pain research & management. 2018. 3562701. 28. Rodriguez CS. Pain measurement in the elderly: a review. Pain Manag Nurs 2001;(2):38-46 29. Altıparmak. B.,et tal. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial Journal of Clinical Anesthesia. 2019;(57):31-36

  BACKGROUND

MeSH Terms

Conditions

Bites and Stings; Pain

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: July 15, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 2, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)