Erector Spinalis Plane Block in Bariatric Surgery

NCT04915521 | Completed

• 1 other identifier: 09.2020.128
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Background/objective: Bariatric surgery is often associated with moderate to severe pain. In obese individuals, opioids have the potential to induce ventilatory impairment; thus, opioid use needs to be limited. This study aimed to compare the novel ultrasound-guided erector spinalis plane block (ESPB) technique with controls in terms of intraoperative opioid consumption and postoperative pain control. Methods: A total of 63 patients with morbid obesity who underwent laparoscopic bariatric surgery were included in this randomized study. Patients were randomly assigned to the bilateral erector spina plane block (ESPB) group or the control group. To evaluate perioperative pain and to adjust opioid dose, analgesia nociception index (ANI) was monitored during surgery. Total opioid dose was recorded for each patient. In addition, pain was evaluated using visual analogue scale (VAS) scores for 24 hours following the operation.

Conditions

Postoperative Pain; Opioid Consumption

Keywords

bariatric surgery; morbid obesity; ultrasound-guidance; erector spinalis plane block (ESPB); visual analogue scale (VAS) score; opioids

Outcome Measures

Primary Outcomes (1)

• total intraoperative opioid consumption,

  To evaluate intraoperatif opioid consumption, ANI was continuously monitored throughout the surgical procedure.

  postoperatif first 24 hours

Secondary Outcomes (1)

• measure vas the change in postoperative pain

  up to 6, 12, and 24 hours.

Study Arms (2)

erector spinae plane block group

ACTIVE COMPARATOR

ESPB group received ultrasound-guided bupivacaine and lidocaine injection at T9 vertebral level before anesthesia induction.

Other: erector spina plane block (ESPB) group

non block control group

NO INTERVENTION

Control group received 5 ml 0.5% bupivacaine injection to each trocar site (total of 25 ml) at the beginning of the operation.

Interventions

erector spina plane block (ESPB) group OTHER

An experienced anesthesiologist performed ESPB in all patients in sitting position bilaterally. A linear ultrasound probe (6-13 MHz) was used for ultrasound guidance. Injection was done using in-plane technique. A 22G block needle (100mm, B-Braun, Germany) was inserted 3- cm lateral to the T9 spinous process and advanced in cranio-caudal direction. To separate erector spina muscle from the transverse process, initially 1-2 ml saline was injected; then 20 ml 0.5% bupivacaine and 5 ml 0.2% lidocaine were injected following separation. Diffusion of the drugs in erector spina plane at cranio-caudal line was ensured. No analgesic or sedative was used during the procedure.

Also known as: non-block control group

erector spinae plane block group

Eligibility Criteria

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

You may qualify if:

• Patients were required to have a BMI ≥40 kg/m
• ASA physical status class 2 or 3.

You may not qualify if:

• any complication (allergic reaction or local anesthesia-related complication)
• failure, or patient refusal during the block procedure
• switch to open surgery or a change in the planned surgical protocol
• analgesia nociception index (ANI) and/or bispectral index (BIS) monitoring not possible

Sponsors & Collaborators

• Meliha Orhon: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Obesity, Morbid

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• MELIHA ORHON ERGUN

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: June 7, 2021
• Study Start: January 10, 2020
• Primary Completion: January 3, 2021
• Study Completion: February 10, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)