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

Sponsor
Istanbul Saglik Bilimleri University (Other)
Overall Status
Completed
CT.gov ID
NCT05706233
Collaborator
(none)
108
1
2.9
36.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector Spina Plane Group
  • Procedure: IV analgesic intervention

Study Design

Study Type:
Observational
Actual Enrollment :
108 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Effect of Postoperative Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy: A Historical Cohort Study
Actual Study Start Date :
Feb 15, 2022
Actual Primary Completion Date :
May 15, 2022
Actual Study Completion Date :
May 15, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Basaksehir Cam and Sakura City Hospital Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Saglik Bilimleri University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taner Abdullah, Specialist, Istanbul Saglik Bilimleri University
ClinicalTrials.gov Identifier:
NCT05706233
Other Study ID Numbers:
  • 2021.11.254
First Posted:
Jan 31, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2023