Clinical trial NCT04064138: Analgesic Effect of Erector Spinea Plane Block Compared to Peritoneal Block in Laparoscopic Cholecystectomy
Official title: Erector Spinea Plane Block Versus Peritoneal Block Analgesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time for first requirement of rescue analgesia
timeFrame: for 24 hours after surgery
Secondary outcomes:
measure: Peripheral oxygen saturation
timeFrame: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.
measure: mean arterial blood pressure
timeFrame: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.
measure: heart rate
timeFrame: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.
measure: end tidal CO2
timeFrame: immediately after intubation and ever 10 min till the end of surgery.
measure: Intensity of Abdominal Pain: visual analogue scale
timeFrame: immediately after recovery ,then every 4 hours for 24 hour.
measure: Intensity of Shoulder Pain: five point scale
timeFrame: immediately after recovery ,then every 4 hours for 24 hour.
measure: serum cortisol level
timeFrame: preoperative and one hour postoperative.
measure: Post-operative total analgesic requirement
timeFrame: for 24 hours postoperatively.
measure: nausea
timeFrame: immediately after recovery and every 4 hours for 24 hour postoperatively
measure: vomiting
timeFrame: immediately after recovery and every 4 hours for 24 hour postoperatively
measure: dizziness
timeFrame: immediately after recovery and every 4 hours for 24 hour postoperatively
measure: tinitus
timeFrame: immediately after recovery and every 4 hours for 24 hour postoperatively
measure: circumoral numbness
timeFrame: immediately after recovery and every 4 hours for 24 hour postoperatively
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University, Central Hospital, gastroenterology surgery centre
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Mohammed A Sultan, MD
role: STUDY_CHAIR
References: