Comparison of Erector Spinae Plane Block and Rectus Sheath Block

Comparison of Intraoperative and Postoperative Effects of Erector Spinae Plane Block and Rectus Sheath Block

In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Other: bupivacaine

Detailed Description

Following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered to all patients. Patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Nilüfer
    • Bursa, Nilüfer, Turkey, 16059
      • Bursa Uludag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18-75 years
• American Society of Anesthesiologists (ASA) classes I-III

Exclusion Criteria:

• Local anesthetic allergy
• Coagulopathy
• Injection site infection
• History of abdominal surgery
• Severe neurological or psychiatric disorder
• Severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2)
• chronic opioid use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group ESPB; Erector spinae plane block	Other: bupivacaine; used for peripheral block
Active Comparator: Group RSB; Rectus sheath block	Other: bupivacaine; used for peripheral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative hemodynamic data and administered opioid doses	Intraoperative hemodynamic values (peripheric oxigen saturation, mean arterial pressure, heart rate) of the patients and intraoperative opioid consumption (mg) were compared.	150 minutes
postoperative visual analog scales at rest and during coughing	Postoperatively, both coughing and resting visual analog scale values (A rating between 0 and 10 was made. 0 no pain 10 severe pain) of the patients were recorded and compared between the groups.	48 hours
time to first patient controlled analgesia (PCA) dose	The times when patients used the PCA device for the first time were recorded and compared between groups.	48 hours
postoperative morphine consumption	Total morphine (mg) consumptions used with postoperative PCA were recorded and compared between groups.	48 hours
need for rescue analgesics	Bolus-dose morphine administration was provided to patients with VAS ≥4 upon questioning in the clinic or in line with patients' complaints, and patients' VAS scores during the first use of PCA were recorded. It was planned for rescue analgesic to be administered in patients with VAS ≥4 despite PCA, firstly as 20 mg IV tenoxicam (Tilcotil®, Deva, Tekirdağ, Turkey), and secondly as 50 mg IV tramadol (Tramosel®, Haver, Istanbul, Turkey) if VAS was still ≥4 one hour after tenoxicam administration.	48 hours
duration time until first mobilization	The times until the first mobilization of the patients were recorded and it was investigated whether there was a difference between the groups in terms of mobilization times.	48 hours
opioid side effects	Side effects (nausea, vomiting and sedation) that may occur due to opioid use in patients were recorded. And it was investigated whether there was a difference between the groups.	48 hours
patient and surgeon satisfaction	Patient and surgical team satisfaction were recorded using a 5-point Likert scale (A rating of 1 to 5 was requested. 1- not at all satisfied 2- somewhat satisfied 3- undecided 4- satisfied 5- very satisfied).The difference between the groups was investigated.	48 hours

Collaborators and Investigators

• Sponsor: Bursa Uludag Universitesi
• Investigators: Principal Investigator: Emre SALMAN, MD, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): August 11, 2021
• Study Completion (Actual): September 9, 2021

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: pain management; erector spinae plane block; rectus sheath block; midline laparotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: TurkishARD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No