Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.

NCT04438369 | Completed

• 1 other identifier: 2018/2239
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Ventral hernia repair is associated with significant postoperative pain, and regional anesthetic techniques are of potential benefit. The postoperative mobility and training is of utmost importance in this patient group, and could be increased using local anesthetics instead of opioids. Inadequate post-operative pain control can lead to adverse consequences for patients, such as the development of chronic pain, immunosuppression, poorer healing of surgical wounds, as well as adrenergic activation and its consequences in the form of coronary incidents or gastrointestinal obstruction and postoperative nausea and vomiting (PONV). Moreover, lack of mobility can result in thrombosis and embolism. These complications affect hospital functioning, which leads to decreased patient satisfaction, a worse reputation for the hospital, longer stays in the recovery room, prolonged hospitalizations, higher incidence of re-surgeries and re-admissions, and higher costs for care and treatment. Erector spinae plane block (ESPB) is the latest of the truncal blocks and was first described in 2016. The efficacy of bilateral ESPB at the T7 level has been described in a study of 4 cases, moreover effective analgesia with ESPB after bariatric surgery has been described in a study of 3 cases. When performed at the level of the T7 transverse process, studies show the potential to block both supra-umbilical and infra-umbilical dermatomes. So far there are mostly case studies done in this field of study, and internationally there is a call for research into the effect of this technique and randomized controlled trials. The objective of this study is to compare ESPB to multimodal analgesia in patients undergoing ventral hernia repair.

Conditions

Ventral Hernia; Postoperative Pain; Regional Anesthesia

Keywords

Erector Spinae Plane Block; Postoperative pain; Ventral hernia repair

Outcome Measures

Primary Outcomes (1)

• Opiat consumption

  The opioid consumption measured in orale morphine equivalents after one hour postoperatively.

  Postoperatively at one hour.

Secondary Outcomes (4)

• Postopertive nausea

  Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.

• Postoperative sedation

  Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.

• Postoperative pain

  Postoperatively at 1-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.

• Quality of recovery 15

  24 hours, 48 hours and 7 days.

Study Arms (2)

Erector spinae block

ACTIVE COMPARATOR

Group ESPB: Multimodal analgesia comprising of preoperative paracetamol adjusted for weight (2000 milligrams (mg) \>70 kilograms (kg) \<70 years, 1500 mg \<70 kg \>70 years, 1000 mg \<50 kg) and diclofenac adjusted for weight (100 mg \>70 kg \<70 years, 50 mg \<70 kg \>70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodon 1 mg/ml. Preoperatively positioned bilateral catheters at level T7 injected with ropivacaine 2,5 mg/ml, 30 ml on each side. Postoperative maintenance treatment with injection of 2 mg/ml ropivacaine 30 ml on each side every 6 hours postoperatively. Maximum allowed bolus preoperative ropivacaine dose is 3 mg/kg body weight (BW), while the maximum 24 hour dose postoperatively is 11 mg/kg to avoid local anesthesia systemic toxicity (LAST). The catheter will be discontinued 24 hours after the original procedure. The container with ropivacaine will be masked for blinding of the personnel on the ward.

Procedure: Erector Spinae Plane Block

Control

PLACEBO COMPARATOR

Control group with standard multimodal analgesia: Preoperative paracetamol adjusted for weight (2000 milligrams (mg) \>70 kilograms (kg) \<70 years, 1500 mg \<70 kg \>70 years, 1000 mg \<50 kg) and diclofenac adjusted for weight (100 mg \>70 kg \<70 years, 50 mg \<70 kg \>70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodone 1 mg/ml. Insertion of bilateral catheters preoperatively. Injection of 30 ml saline preoperatively and every 6 hours postoperatively. The catheter will be discontinued 24 hours after the original procedure. The container with saline will be masked for blinding of the personnel on the ward.

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

Cathether based Erector Spinae Plane Block for postoperative pain management.

Control; Erector spinae block

Eligibility Criteria

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

You may qualify if:

• Age \>18
• BMI (body mass index) 18,5 - 40 and weight \>65 kg
• ASA (American Association of Anesthesiologists Classification system for physical status) I-III .
• Scheduled for elective ventral hernia operation
• Planned hospital stay \>24 hrs

You may not qualify if:

• Allergy to latex, local anesthesia, Non-Steroidal Anti-Inflammatory Drugs or opioids
• Diabetes
• Chronic pain with daily opiate use
• Patients with severe renal and/or hepatic disease
• Local infection at the site of injection
• Systemic infection
• AV block 2-3
• Inability to understand written or spoken Norwegian
• Inability to cooperate
• Dementia
• Known abuse of alcohol or medication
• Pregnancy
• Weight under 65 kg

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

Study Sites (1)

Ostfold Hospital Trust, Moss

Moss, Østfold fylke, 1535, Norway

Location

Related Publications (1)

• Sorenstua M, Raeder J, Vamnes JS, Leonardsen AL. Evaluation of the Erector spinae plane block for postoperative analgesia in laparoscopic ventral hernia repair: a randomized placebo controlled trial. BMC Anesthesiol. 2024 May 29;24(1):192. doi: 10.1186/s12871-024-02566-x.

  PMID: 38811911 DERIVED

MeSH Terms

Conditions

Hernia, Ventral; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marie Soerenstua, MD

  Sykehuset Ostfold HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization was done through a computer-generated block randomization process (randomization.com) to reduce bias. The block sizes were randomly chosen to 2, 4 and 6. The total patients randomized were 60 patients to account for missing data and protocol violations. A study nurse prepared and placed the notes of study allocation covered with aluminum foil into opaque envelopes. The envelopes were numbered from 1- 70.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is planned as a randomized controlled trial (RCT) with two study arms. One arm is the intervention arm, who will receive the active treatment. The other arm is the control arm, who will receive a placebo treatment.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: September 1, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 31, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At publication date and for three months.

Locations

NO (1)