Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy

NCT05706233 | Completed

• 1 other identifier: 2021.11.254
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy, one of the most commonly performed abdominal surgeries, is a gold standard therapy for surgical treatment of benign biliary diseases. Erector spinae plane block (ESPB) was first presented in 2016 as the treatment of neuropathic pain in a case series, and gained popularity very quickly due to its safety applicability, and effect on both the visceral and parietal component of pain by providing paravertebral, transforaminal and epidural spread. Preoperative application of ESPB has taken its place as a part of multimodal analgesia in laparoscopic cholecystectomy cases over time and has been shown to reduce postoperative pain scores and opioid consumption and to improve quality of recovery scores. However, there is no data regarding the use of ESPB in the postoperative period as a rescue therapy.

Conditions

Regional Anesthesia Morbidity; Cholecystitis, Chronic

Outcome Measures

Primary Outcomes (1)

• effect of ESPB applied postoperatively on the meperidine consumption in PACU

  As part of the standardized perioperative care management, the pain intensity is evaluated with the numeric pain rating scale (NRS). If the NRS is \> 3 meperidine bolus or ESPB is applied in line with the patients' selection and the patients are evaluated in every 5 min in terms of their NRS scores until NRS \< 4 is achieved. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied. All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS \> 3, 20 mg if NRS \> 5, 30 mg if NRS \> 8. NRS scores and meperidine boluses applied are recorded on the PACU follow-up form.

  1 HOUR

Secondary Outcomes (1)

• effect of ESPB applied postoperatively on numeric rating scores in PACU

  1 HOUR

Study Arms (2)

Erector Spina Plane Block (ESPB)

Procedure: Erector Spina Plane Group

Intravenous Group (IV)

Procedure: IV analgesic intervention

Interventions

Erector Spina Plane Group PROCEDURE

ESPB had been applied postoperatively: from T8 level, 20mL bupivacaine %0,5 + 5ml %2 lidocaine was applied.

Erector Spina Plane Block (ESPB)

IV analgesic intervention PROCEDURE

IV analgesics had been applied: All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS \> 3, 20 mg if NRS \> 5, 30 mg if NRS \> 8. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied.

Intravenous Group (IV)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing laparoscopic cholecystectomy

You may qualify if:

• Patients undergoing laparoscopic cholecystectomy
• Patients with NRS\>3 scores in the PACU

You may not qualify if:

• ASA \> 2
• Violation of standart protocol (anesthesia and analgesia)
• application of ESPB preoperatively
• age \> 65
• Surgery duration \>90min or \<45min

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Istanbul Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholecystitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 31, 2023
• Study Start: February 15, 2022
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)