NCT04064138

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laparoscopic Cholecystectomy

Interventions

Type	Name	Description
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.
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.
OTHER	General anesthesia	General anesthesia

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2019-08-21
• Last updated: 2020-09-04

Locations

1 site across 1 country: Egypt