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

Completed

• Conditions: Regional Anesthesia Morbidity; Cholecystitis, Chronic
• Interventions: Procedure: IV analgesic intervention; Procedure: Erector Spina Plane Group

• Registration Number: NCT05706233
• Lead Sponsor: Istanbul Saglik Bilimleri University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Primary Completion: 2022-05-15
• Study Completion: 2022-05-15
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intravenous Group (IV)	IV analgesic intervention	-
Erector Spina Plane Block (ESPB)	Erector Spina Plane Group	-

Primary Outcome Measures

Name	Time	Method
effect of ESPB applied postoperatively on the meperidine consumption in PACU	1 HOUR	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.

Secondary Outcome Measures

Name	Time	Method
effect of ESPB applied postoperatively on numeric rating scores in PACU	1 HOUR	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.

Trial Locations

Locations (1)

Istanbul Basaksehir Cam and Sakura City Hospital; 🇹🇷 Istanbul, Turkey