Pain Clinical Trial
— EFFECTOfficial title:
Effectiveness of Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Colectomies -A Randomized, Controlled, Double Blind, Prospective Trial
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: ASA I, II, III Laparoscopic colectomy Elective surgery Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Georgios Papanikolaou, General Hospital of Thessaloniki | Thessaloníki | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Democritus University of Thrace | Aristotle University Of Thessaloniki |
Greece,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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(®)) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Perioperative Tramadol Consumption | Total Perioperative Tramadol Consumption | 96 hours after surgery | |
Primary | 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 | |
Primary | Mobilization Time | Time of Mobilization of the gastrointestinal tract and of the patient | In a time frame of up to 72 hours Post - Operatively | |
Primary | 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 | |
Primary | 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 | |
Primary | Hospitalization Days | Duration of hospital stay after surgery in days | In a time frame up to 2 Weeks Post - Operatively | |
Secondary | Pain Score, Post Operative Nausea and Vomiting Score at discharge from Post-Anesthesia Care Unit (PACU) | Pain score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting. | Immediately Post - Operatively | |
Secondary | Pain Score, Post Operative Nausea and Vomiting Score 12 hours post-operatively | Pain score 12 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 12 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting. | 12 hours post - operatively | |
Secondary | Pain Score, Post Operative Nausea and Vomiting Score 24 hours post-operatively | Pain score 24 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 24 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting. | 24 hours post - operatively | |
Secondary | Pain Score, Post Operative Nausea and Vomiting Score 36 hours post-operatively | Pain score 36 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 36 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting. | 36 hours post - operatively | |
Secondary | Pain Score, Post Operative Nausea and Vomiting Score 48 hours post-operatively | Pain score 48 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 48 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting. | 48 hours post - operatively | |
Secondary | Total Desflurane Consumption | Total intraoperative Desflurane Consumption | Intra - Operatively | |
Secondary | Total Remifentanyl Consumption | Total intraoperative Remifentanyl Consumption | Intra - Operatively | |
Secondary | Post Anesthesia Care Unit (PACU) Duration of stay | Duration of patient stay at PACU | Immediately post-operatively | |
Secondary | Total Cost | Total cost of surgery, anesthesia and hospitalization | Perioperatively | |
Secondary | TNF-a, IL-1, IL-6 levels post-operatively | Comparison of TNF-a, Interleukine-1 and Interleukine-6 levels preoperatively and post - operatively (the first and fourth day after surgery) | Pre-operatively and the 1st and 4th day post-operatively |
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