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

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Erector Spinea Plane Block Versus Peritoneal Block Analgesia in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064138
• Other study ID #: MS / 19.01.436
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: December 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Procedure:
• Peritoneal block
At the beginning of surgery, immediately after insertion of the first port 2 mg/kg lidocaine and 25mg/kg magnesium sulfate and 1/200 000 epinephrine in a total volume 50 ml (completed with saline .9%) will be given intra-peritoneal 10 min before the surgeon proceeds . At the end of the surgery another similar lidocaine-magnesium-epinephrine injection will be instillated before removal of the last port and the drain will be kept closed for 30 min.
• Ultrasound guided erector spinae plane block
Before general anesthesia, ESPB will be performed under ultrasound guidance. The linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. The patient's skin will be anesthetized with 3 mL of 2% lidocaine. A 21 gauge 10cm needle will be inserted using an in plane superior to inferior. The tip of the needle will be placed into the facial plane on the deep aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process on ultrasonographical imaging. The calculated dose of lidocaine (2mg/kg) with 150 mg MgSo4 and 1/200 000 epinephrine will be injected on each side.

Other:
• General anesthesia
General anesthesia

Locations

Country	Name	City	State
Egypt	Mansoura University, Central Hospital, gastroenterology surgery centre	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

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