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Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy

M

Maltepe University

Status

Completed

Conditions

Postoperative Pain

Treatments

Procedure: ESP Block
Procedure: OSTAP block
Other: Standard Pain Followup and Monitorization

Study type

Interventional

Funder types

Other

Identifiers

NCT03508531
ESPvsOSTAP

Details and patient eligibility

About

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic.Oblique subcostal transverse abdominis plane block (OSTAP) is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and OSTAP in laparoscopic cholecystectomy.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

-Elective laparoscopic Cholecystectomy, ASA status 1-2 -

Exclusion criteria

  • Patient refusal
  • Contraindications to regional anesthesia
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Use of any anti-coagulants
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Inability to operate PCA system
  • Patient with psychiatric disorders

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

60 participants in 3 patient groups

ESP Block
Active Comparator group
Description:
Ultrasound-guided bilateral Erector spinae plane block performed at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.
Treatment:
Other: Standard Pain Followup and Monitorization
Procedure: ESP Block
OSTAP Block
Active Comparator group
Description:
Ultrasound-guided bilateral OSTAP block performed at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.
Treatment:
Other: Standard Pain Followup and Monitorization
Procedure: OSTAP block
Control
Sham Comparator group
Description:
Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed. No block will be performed in this group.
Treatment:
Other: Standard Pain Followup and Monitorization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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