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Clinical Trials/NCT04167176
NCT04167176
Completed
Not Applicable

Comparison of Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block With Port Site Infiltration Following Laparoscopic Cholecystectomy

Assiut University1 site in 1 country44 target enrollmentSeptember 15, 2020

Overview

Phase
Not Applicable
Intervention
Erector spinae plane block
Conditions
Postoperative Pain
Sponsor
Assiut University
Enrollment
44
Locations
1
Primary Endpoint
Total postoperative opioid consumption.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.

Registry
clinicaltrials.gov
Start Date
September 15, 2020
End Date
September 17, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Magdy Mohammed Mahdy Sayed

Principal Investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • patients with the American Society of Anesthesiologists (ASA) physical status I/II,
  • Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,
  • Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria

  • Allergy to local anaesthetics,
  • Infection at the site of injection,
  • , Coagulopathy,
  • Chronic pain syndromes,
  • Prolonged opioid medication,
  • Patients who received any analgesic 24 h before surgery

Arms & Interventions

Erector spinae plane block

ultrasound guided ESP Block after anaesthesia induction

Intervention: Erector spinae plane block

Erector spinae plane block

ultrasound guided ESP Block after anaesthesia induction

Intervention: Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)

Erector spinae plane block

ultrasound guided ESP Block after anaesthesia induction

Intervention: Bupivacaine 0.5%

Erector spinae plane block

ultrasound guided ESP Block after anaesthesia induction

Intervention: Lidocaine 2%

Port site infiltration technique

After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites

Intervention: Port site infiltration

Port site infiltration technique

After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites

Intervention: Bupivacaine 0.5%

Port site infiltration technique

After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites

Intervention: Lidocaine 2%

Outcomes

Primary Outcomes

Total postoperative opioid consumption.

Time Frame: 24 hours postoperatively

Nalbuphine consumption in mg.(equivalent to morphine dose)

Secondary Outcomes

  • Pain scores;Numerical Rating Scale (NRS) at rest and when coughing(at 1, 2,4 , 8, 16 and 24 hours postoperatively.)
  • •Cumulative postoperative analgesic consumption(24 hours postoperatively)
  • •Heart Rate (HR)(Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery)
  • •Mean Arterial Pressure (MAP)(Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery)
  • Incidence and severity Postoperative nausea & vomiting (PONV).(24 hours postoperatively)

Study Sites (1)

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