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

Effect of Postoperative Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy: A Historical Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Regional Anesthesia Morbidity; Cholecystitis, Chronic
• Intervention / Treatment: Procedure: Erector Spina Plane Group; Procedure: IV analgesic intervention

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Basaksehir Cam and Sakura City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients undergoing laparoscopic cholecystectomy

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Erector Spina Plane Block (ESPB)	Procedure: Erector Spina Plane Group; ESPB had been applied postoperatively: from T8 level, 20mL bupivacaine %0,5 + 5ml %2 lidocaine was applied.
Intravenous Group (IV)	Procedure: IV analgesic intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of ESPB applied postoperatively on numeric rating scores 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

Collaborators and Investigators

• Sponsor: Istanbul Saglik Bilimleri University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): May 15, 2022

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: 2021.11.254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No