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

Regional Anesthesia Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706233
• Other study ID #: 2021.11.254
• Status: Completed
• Start date: February 15, 2022
• Est. completion date: May 15, 2022

Study information

• Verified date: June 2023
• Source: Istanbul Saglik Bilimleri University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Chronic
• Regional Anesthesia Morbidity

Intervention

Procedure:
• Erector Spina Plane Group
ESPB had been applied postoperatively: from T8 level, 20mL bupivacaine %0,5 + 5ml %2 lidocaine was applied.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Basaksehir Cam and Sakura City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Saglik Bilimleri University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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