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

Erector Spinea Plane Block Versus Peritoneal Block Analgesia in Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Other: General anesthesia; Procedure: Peritoneal block; Procedure: Ultrasound guided erector spinae plane block

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University, Central Hospital, gastroenterology surgery centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peritoneal block; patients will receive peritoneal block as an adjuvant analgesic technique.	Other: General anesthesia; General anesthesia; 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.
Active Comparator: Ultrasound guided erector spinae plane block; Patients will receive ultrasound guided erector spinae plane block	Other: General anesthesia; General anesthesia; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
end tidal CO2	amount of carbon dioxide in each breathe .	immediately after intubation and ever 10 min till the end of surgery.
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.
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.
serum cortisol level	a steroid hormone secreted from adrenal cortex in response to stress.	preoperative and one hour postoperative.
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.
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mohammed A Sultan, MD, Professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: MS ∕ 19.01.436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: individual participant data will be available.; all individual participant data collected during the trial after deidentification will be shared.; The data will be shared with anyone who wishes to access the data for any purpose .
• IPD Sharing Time Frame: data will be available immediately following publication with no end date
• IPD Sharing Access Criteria: individual participant data will be available.; all individual participant data collected during the trial after deidentification will be shared.; study protocol, statistical analysis and informed consent form will be available.; data will be available immediately following publication with no end date.; the data will be shared with anyone who wishes to access the data for any purpose.; data will be available at www.researchgate.net/profile/Sameh_Ghareeb3
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No