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

Not Applicable

Completed

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Procedure: Ultrasound guided erector spinae plane block; Procedure: Peritoneal block; Other: General anesthesia

• Registration Number: NCT04064138
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2019-12
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• American physical status classes I and II

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peritoneal block	General anesthesia	patients will receive peritoneal block as an adjuvant analgesic technique.
Ultrasound guided erector spinae plane block	Ultrasound guided erector spinae plane block	Patients will receive ultrasound guided erector spinae plane block
Peritoneal block	Peritoneal block	patients will receive peritoneal block as an adjuvant analgesic technique.
Ultrasound guided erector spinae plane block	General anesthesia	Patients will receive ultrasound guided erector spinae plane block

Primary Outcome Measures

Name	Time	Method
Time for first requirement of rescue analgesia	for 24 hours after surgery	an analgesic (nalbuphine 10 mg ) will be administer postoperatively on patient request in case of the pain score ≥ 4/10 on VAS. It represent the end point of the study which determines the duration of analgesia

Secondary Outcome Measures

Name	Time	Method
heart rate	one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.	Number of heart beats per minute. Lower heart rate implies better cardiovascular fitness and less stress.
Intensity of Abdominal Pain: visual analogue scale	immediately after recovery ,then every 4 hours for 24 hour.	Postoperative assessment of abdominal pain using visual analogue scale (1-10), where 1 equals no pain and 10 indicates the worst possible pain.
Intensity of Shoulder Pain: five point scale	immediately after recovery ,then every 4 hours for 24 hour.	shoulder pain score scale: 1. no pain( the best outcome); 2. discomfort in shoulder but no pain; 3. light pain ( analgesia not required); 4. moderate pain ( analgesia required); 5. sever pain ( analgesia and sedation required ) (the worst outcome)
end tidal CO2	immediately after intubation and ever 10 min till the end of surgery.	amount of carbon dioxide in each breathe .
serum cortisol level	preoperative and one hour postoperative.	a steroid hormone secreted from adrenal cortex in response to stress.
nausea	immediately after recovery and every 4 hours for 24 hour postoperatively	four point verbal rating score to assess the incidence of nausea and vomiting where 1 indicate they did not happen , 2 indicate nausea and 3 indicate vomiting for once and 4 indicate repeated vomiting
Peripheral oxygen saturation	one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.	estimate of oxygenated hemoglobin concentration in the blood , measured by pulse oximeter device
mean arterial blood pressure	one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.	The average pressure in the arteries during one cardiac cycle.
circumoral numbness	immediately after recovery and every 4 hours for 24 hour postoperatively	a questionnaire will be collected to detect the incidence of occurrence of circumoral numbness
tinitus	immediately after recovery and every 4 hours for 24 hour postoperatively	a questionnaire will be collected to detect the incidence of occurrence of tinnitus
Post-operative total analgesic requirement	for 24 hours postoperatively.	total amount of nalbuphine consumed by the patient from the time of first analgesic requirement till the end of 24 hours.
vomiting	immediately after recovery and every 4 hours for 24 hour postoperatively	four point verbal rating score to assess the incidence of nausea and vomiting where 1 indicate they did not happen , 2 indicate nausea and 3 indicate vomiting for once and 4 indicate repeated vomiting.
dizziness	immediately after recovery and every 4 hours for 24 hour postoperatively	a questionnaire will be collected to detect the incidence of occurrence of dizziness

Trial Locations

Locations (1)

Mansoura University, Central Hospital, gastroenterology surgery centre; 🇪🇬 Mansoura, DK, Egypt