EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial

NCT04879004 | Unknown

• 1 other identifier: 1147/7.10.2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the trial is to study the efficacy of continuous bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic colectomy.

Conditions

Pain, Postoperative; Acute Pain; Postoperative Complications; Pain; Ropivacaine; Analgesia; Regional Anesthesia; Analgesics; Anesthesia, Local; Colorectal Cancer; Perioperative Pain

Keywords

Erector Spinae Plane Block; Regional Anaesthesia; Opioid - Free Anaesthesia; Opioid Sparing Techniques; Laparoscopic Colectomy; Perioperative Pain; General Surgery

Outcome Measures

Primary Outcomes (6)

• Total Perioperative Tramadol Consumption

  Total Perioperative Tramadol Consumption

  96 hours after surgery

• Quality of Recovery

  Quality of Recovery-15 \[(QoR) -15\] Questionnaire. A questionnaire which consists of 15 questions in two Parts, rated from 0 to 10 ("0" is the worst and "10" is the best answer). The worst overall score is 0 and the best overall score is 150.

  72 hours Post - Operatively

• Mobilization Time

  Time of Mobilization of the gastrointestinal tract and of the patient

  In a time frame of up to 72 hours Post - Operatively

• Start of Oral Fluids and Nutrition

  Time of start of oral fluids and enteral nutrition

  In a time frame up to 72 hours Post - Operatively

• Satisfaction from Perioperative Analgesia

  Satisfaction Score of the patient regarding perioperative analgesia, using a numerical rating scale from 1 to 6, where "1" means not satisfied at all and "6" means completely satisfied.

  96 hours post - operatively

• Hospitalization Days

  Duration of hospital stay after surgery in days

  In a time frame up to 2 Weeks Post - Operatively

Secondary Outcomes (10)

• Pain Score, Post Operative Nausea and Vomiting Score at discharge from Post-Anesthesia Care Unit (PACU)

  Immediately Post - Operatively

• Pain Score, Post Operative Nausea and Vomiting Score 12 hours post-operatively

  12 hours post - operatively

• Pain Score, Post Operative Nausea and Vomiting Score 24 hours post-operatively

  24 hours post - operatively

• Pain Score, Post Operative Nausea and Vomiting Score 36 hours post-operatively

  36 hours post - operatively

• Pain Score, Post Operative Nausea and Vomiting Score 48 hours post-operatively

  48 hours post - operatively

Study Arms (2)

Ropivacaine Group

EXPERIMENTAL

ESPB performed with infusion of Ropivacaine 0,375% (20 ml at ech side)

Drug: Ropivacaine injection

Control Group

PLACEBO COMPARATOR

ESPB performed with infusion of N/S 0,9% (20 ml at each side)

Drug: Ropivacaine injection

Interventions

Ropivacaine injection DRUG

Effect of continuous ESPB performed with Ropivacaine 0,375% infusion, in patients undergoing elective laparoscopic colectomy.

Control Group; Ropivacaine Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I, II, III Laparoscopic colectomy Elective surgery

You may not qualify if:

• Patient refusal Known allergies to local anesthetics Other contraindications to regional anesthesia Infection or anatomic anomalies on injection site Uncontrolled hypertension Severe liver or kidney disease Pregnancy Known depression or psychiatric disorders, dementia Drug or alcohol abuse Inadequate command of Greek language

Sponsors & Collaborators

• Democritus University of Thrace: lead
• Aristotle University Of Thessaloniki: collaborator

Study Sites (1)

Georgios Papanikolaou, General Hospital of Thessaloniki

Thessaloniki, Thessaloniki, 57010, Greece

RECRUITING

Related Publications (7)

• Kwon HM, Kim DH, Jeong SM, Choi KT, Park S, Kwon HJ, Lee JH. Does Erector Spinae Plane Block Have a Visceral Analgesic Effect?: A Randomized Controlled Trial. Sci Rep. 2020 May 21;10(1):8389. doi: 10.1038/s41598-020-65172-0.

  PMID: 32439926 BACKGROUND

• Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.

  PMID: 30868029 BACKGROUND

• Beck DE, Margolin DA, Babin SF, Russo CT. Benefits of a Multimodal Regimen for Postsurgical Pain Management in Colorectal Surgery. Ochsner J. 2015 Winter;15(4):408-12.

  PMID: 26730224 BACKGROUND

• Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.

  PMID: 23052794 BACKGROUND

• Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.

  PMID: 18443635 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• De Cassai A, Cin SD, Zarantonello F, Ban I. Erector spinae plane block as a rescue therapy for uncontrolled pain after laparotomic surgery: A report of two cases. Saudi J Anaesth. 2019 Jan-Mar;13(1):66-68. doi: 10.4103/sja.SJA_449_18.

  PMID: 30692892 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Postoperative Complications; Pain; Agnosia; Colorectal Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Freideriki Sifaki, M.D., MSc

CONTACT

00306970721829; frida1sif1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Msc

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 10, 2021
• Study Start: January 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)