Skip to main content
OpenTrials
Completed

NCT Number: NCT04064138

Analgesic Effect of Erector Spinea Plane Block Compared to Peritoneal Block 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laparoscopic Cholecystectomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University, Central Hospital, gastroenterology surgery centre

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

General anesthesia

Other

General anesthesia

Primary outcomes

  1. Time for first requirement of rescue analgesia

    Time frame: for 24 hours after surgery

    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

Secondary outcomes

  1. Peripheral oxygen saturation

    Time frame: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.

    estimate of oxygenated hemoglobin concentration in the blood , measured by pulse oximeter device

  2. mean arterial blood pressure

    Time frame: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.

    The average pressure in the arteries during one cardiac cycle.

  3. heart rate

    Time frame: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.

    Number of heart beats per minute. Lower heart rate implies better cardiovascular fitness and less stress.

  4. end tidal CO2

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

    amount of carbon dioxide in each breathe .

  5. Intensity of Abdominal Pain: visual analogue scale

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

    Postoperative assessment of abdominal pain using visual analogue scale (1-10), where 1 equals no pain and 10 indicates the worst possible pain.

  6. Intensity of Shoulder Pain: five point scale

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

    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)

  7. serum cortisol level

    Time frame: preoperative and one hour postoperative.

    a steroid hormone secreted from adrenal cortex in response to stress.

  8. Post-operative total analgesic requirement

    Time frame: for 24 hours postoperatively.

    total amount of nalbuphine consumed by the patient from the time of first analgesic requirement till the end of 24 hours.

  9. nausea

    Time frame: immediately after recovery and every 4 hours for 24 hour postoperatively

    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

  10. vomiting

    Time frame: immediately after recovery and every 4 hours for 24 hour postoperatively

    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.

  11. dizziness

    Time frame: immediately after recovery and every 4 hours for 24 hour postoperatively

    a questionnaire will be collected to detect the incidence of occurrence of dizziness

  12. tinitus

    Time frame: immediately after recovery and every 4 hours for 24 hour postoperatively

    a questionnaire will be collected to detect the incidence of occurrence of tinnitus

  13. circumoral numbness

    Time frame: immediately after recovery and every 4 hours for 24 hour postoperatively

    a questionnaire will be collected to detect the incidence of occurrence of circumoral numbness

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Erector Spinea Plane Block Versus Peritoneal Block Analgesia in Laparoscopic Cholecystectomy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2019
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.