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Analgesic Effect of Erector Spinea Plane Block Compared to Peritoneal Block in Laparoscopic Cholecystectomy

M

Mansoura University

Status

Completed

Conditions

Laparoscopic Cholecystectomy

Treatments

Procedure: Ultrasound guided erector spinae plane block
Procedure: Peritoneal block
Other: General anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT04064138
MS ∕ 19.01.436

Details and patient eligibility

About

The aim of this study is to detect weather peritoneal block or erector spinae plane block will provide the most ideal analgesia for patients undergoing laparoscopic cholecystectomy. Peritoneal block by instillation of local anesthetic into the peritoneal cavity will act by blocking the free afferent nerve endings in the peritoneum and the systemic absorption of local anesthetic from the peritoneal cavity may also play a part in reduced pain.

On the other hand ,the erector spinae plane block is a novel analgesic technique that provide both visceral and somatic analgesia due to its communication with the paravertebral space. Local anesthetic mixture of lidocaine , magnesium sulphate and epinephrine will be used for both techniques.

Full description

The pain that a patient feels after laparoscopic cholecystectomy results from three different and clinically separate components: somatic pain due to trocar insertion sites , visceral pain due to surgical dissection and tissue handling at the gall bladder bed, and shoulder pain due to retention of carbon dioxide in the abdomen, which irritates the phrenic nerve and diaphragm. Ineffective treatment of post laparoscopic cholecystectomy pain may delay recovery and mandate inpatient admission and therapy and increase the cost of such care.

The aim of this study is to evaluate the analgesic effect of Erector spinea plane block in comparison with peritoneal block for laparoscopic cholecystectomy. Serum level of cortisol as a stress biomarker ,perioperative primary hemodynamics ,visual analogue scale , patient request for rescue analgesia and occurrence of side effects are the parameters for comparison between both techniques. Each patient will be followed up for 24 hours postoperatively.

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American physical status classes I and II

Exclusion criteria

  • Patient refusal.
  • Pregnancy
  • Neuromuscular diseases (as myopathies, myasthenia gravies...)
  • Hematological diseases.
  • Bleeding diseases.
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection at site of the block.
  • Local skin sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m2.
  • Chronic renal disease.
  • Chronic hepatic disease.
  • Preexisting neurological deficit.
  • Conversion to open cholecystectomy
  • Excessively long surgical times (> 90 min)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

Peritoneal block
Active Comparator group
Description:
patients will receive peritoneal block as an adjuvant analgesic technique.
Treatment:
Other: General anesthesia
Procedure: Peritoneal block
Ultrasound guided erector spinae plane block
Active Comparator group
Description:
Patients will receive ultrasound guided erector spinae plane block
Treatment:
Procedure: Ultrasound guided erector spinae plane block
Other: General anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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