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Pain Management in Laparoscopic Cholecystectomies

Comparison of the Effects of Erector Spina Plan Block and Paravertebral Block in Laparoscopic Cholecystectomies on Pain Management.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05837702
Enrollment
90
Registered
2023-05-01
Start date
2022-01-10
Completion date
2023-01-10
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve Block

Keywords

Erector Spinae Plane Block, Paravertebral Block, Laparoscopic Cholecystectomy

Brief summary

Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.

Detailed description

The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.

Interventions

PROCEDUREESPB

Erector spinae plane block

PROCEDUREPVB

Paravertebral Block

PROCEDURECONTROL

No block has been done

Sponsors

Giresun University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* aged \>18 years * patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery

Exclusion criteria

* Did not provide informed consent, * Had any psychiatric or mental problem that prevented understanding of the informed consent form * They were planned to undergo emergency cholecystectomy, * Had any allergy or hypersensitivity to local anaesthetic, * Had an infection in the needle entry area * History of coagulopathy or the use of anticoagulants

Design outcomes

Primary

MeasureTime frameDescription
Total tramadol consumption24 hours postoperativelyConsumption at the end of 24 hours will be monitored by planning a 10mg bolus, a 10-minute lock-in time, through a patient-controlled analgesia device.

Secondary

MeasureTime frameDescription
Analgesic drug consumption other than tramadol24 hours postoperativelyin mg
Heart Ratepreoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)beats /min
Visual analog scale (VAS) at rest and when coughingat 0, 5, 10,20 minutes and 1, 2,4 , 6, 12 and 24 hours postoperatively11-point scale where 0=no pain and 10=worst pain
Incidence of postoperative nausea & vomiting (PONV)24 hours postoperativelyNumber of patients developing PONV
Shoulder pain24 hours postoperativelyNumber of patients developing shoulder pain
Mean arterial pressure (MAP)preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)mm-hg

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026