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OpenTrials
Completed

NCT Number: NCT05706233

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

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.

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Key information

Conditions

Regional Anesthesia Morbidity Biliary Tract Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cholecystitis Cholecystitis, Chronic Digestive System Diseases Gallbladder Diseases Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spina Plane Group

Procedure

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

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.

Primary outcomes

  1. effect of ESPB applied postoperatively on the meperidine consumption in PACU

    Time frame: 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 outcomes

  1. effect of ESPB applied postoperatively on numeric rating scores in PACU

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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