Comparison of Erector Spinae Plane Block and Rectus Sheath Block

NCT05225766 | Completed

• 1 other identifier: TurkishARD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain, Acute

Keywords

erector spinae plane block; rectus sheath block; pain management; midline laparotomy

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Group ESPB

ACTIVE COMPARATOR

Erector spinae plane block

Other: bupivacaine

Group RSB

ACTIVE COMPARATOR

Rectus sheath block

Other: bupivacaine

Interventions

bupivacaine OTHER

used for peripheral block

Group ESPB; Group RSB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University

Bursa, Nilüfer, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Emre SALMAN, MD

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: February 7, 2022
• Study Start: February 25, 2021
• Primary Completion: August 11, 2021
• Study Completion: September 9, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)