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

NCT04064138 | Completed DMC

• 1 other identifier: MS ∕ 19.01.436
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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.

• 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.

• 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.

• end tidal CO2

  immediately after intubation and ever 10 min till the end of surgery.

• Intensity of Abdominal Pain: visual analogue scale

  immediately after recovery ,then every 4 hours for 24 hour.

Study Arms (2)

Peritoneal block

ACTIVE COMPARATOR

patients will receive peritoneal block as an adjuvant analgesic technique.

Procedure: Peritoneal block; Other: General anesthesia

Ultrasound guided erector spinae plane block

ACTIVE COMPARATOR

Patients will receive ultrasound guided erector spinae plane block

Procedure: Ultrasound guided erector spinae plane block; Other: General anesthesia

Interventions

Peritoneal block PROCEDURE

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.

Peritoneal block

Ultrasound guided erector spinae plane block PROCEDURE

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.

Ultrasound guided erector spinae plane block

General anesthesia OTHER

General anesthesia

Peritoneal block; Ultrasound guided erector spinae plane block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American physical status classes I and II

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Central Hospital, gastroenterology surgery centre

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Mohammed A Sultan, MD

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: \- Single blind (participant) study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: August 21, 2019
• Study Start: July 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 4, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: data will be available immediately following publication with no end date
• Access Criteria: 1. individual participant data will be available. 2. all individual participant data collected during the trial after deidentification will be shared. 3. study protocol, statistical analysis and informed consent form will be available. 4. data will be available immediately following publication with no end date. 5. the data will be shared with anyone who wishes to access the data for any purpose. 6. data will be available at www.researchgate.net/profile/Sameh\ Ghareeb3

Locations

EG (1)