Efficacy of Erector Spinae Plane (ESP) Block in Patients With Inflammatory Bowel Disease (IBD)

S

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Enrolling

Conditions

Opioid Use

Treatments

Drug: normal saline
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06230003
20-0272-A

Details and patient eligibility

About

This will be a prospective, double-blind randomized controlled clinical trial. There will be two arms of treatment: intervention and control group. Preoperatively patients will be allocated at random to receive ultrasound guided bilateral ESP block either with the local anesthetic (intervention group) normal saline (control group). The aim of this study is to examine the effect of ESP block to increase the Quality of Recovery (measured via QoR-15 total score) and decrease opioid consumption.

Full description

Inclusion and Exclusion criteria: Adults (18-85 years old), diagnosed with IBD with ASA physical status I-III, coming for IBD abdominal laparoscopic assisted surgeries under general anesthesia, will be enrolled at SHS. Patients will be excluded from the study if they are unable to communicate in English, unstable requiring emergency surgery, open laparotomies, morbidly obese, pregnant, on chronic opioid treatment and known allergies to local anesthetics, altered mental status and concomitant injuries. Work Plan: This prospective trial would include IBD patients undergoing laparoscopic or laparoscopic assisted abdominal surgery. Patients generally have pre-anesthetic visits 1-2 weeks prior to their scheduled operation. Patients identified by the clinical Research Study Assistant (CRSA) based on inclusion and exclusion criteria, will be approached regarding this study in the pre-anesthetic clinic. Patients will be made aware of the components of the study and the CRSA will be present to answer any questions. Patients will be allocated at random to receive ultrasound guided ESP block either with the local anesthetic of 0.5% of Ropivicane 20 mL bilaterally (intervention group) or normal saline (control group) before surgery which will take 5-10 minutes in a 1:1 ratio. Anesthesiologist and patients will be blinded of the allocation. Allocation sequence will be concealed using opaque, sealed, consecutively numbered envelopes. Written informed consent will be obtained from all participants after confirmation of eligibility. Baseline measurements will be made by the CRSA in the pre-anesthetic Clinic. The study coordinator will collect the data once a day for maximum 10 minutes each time up to 3 days postoperatively. There will be a virtual (via telephone) follow up data for quality of life (QoL) at "6 weeks" post-discharge. Sample Size: Sample size justification was based on the primary outcome, QoR15, and the primary objective. According to the previous report10 and our preliminary data, the mean (std) of the total score of QoR15 was conservatively assumed as 98 for patients in control group. The investigators estimated a sample size of 84 (42 per group) will achieve 80% power to detect an absolute 10 point increase in total score of QoR15 for patients in intervention group compared to the control group. A two-sided two-sample equal-variance t-test was used for the power analysis assuming a significance level of 0.05. To account for possible 5% lost follow up, the investigators will recruit a total of 90 patients for this study. Performance of ESP block: Patient Selection. A thorough history, physical exam, and informed consent are carried out. Altered mental status, concomitant injuries, and intubation/ ventilation are considerations primarily with regard to the ability to position the patient safely and access the Paraspinal area to perform the block. The investigators do not view coagulopathy or the use of anticoagulants or antiplatelet drugs as absolute contraindications to ESP block because the theoretical risk of clinically significant hemorrhage or hematoma is very low; however, an individualized risk-benefit assessment should be performed for every patient. Block Equipment and Preparation. In the majority of patients, the investigators will use a high-frequency (10-15 MHz) linear-array transducer because it provides a higher-resolution image; however, a low-frequency (5-2 MHz) curvilinear probe is useful in more obese patients where the transverse processes lie at a depth greater than 4 cm. The block is performed before induction of anesthesia with full aseptic precautions, and the usual precautions for any regional anesthesia procedures will be applied. Scanning Technique. After patients are positioned optimally (sitting or lateral decubitus), the affected area is identified along with the target transverse process. The ultrasound transducer is placed in a longitudinal parasagittal orientation, about 3 cm lateral to the spinous processes, allowing for visualization of adjacent transverse processes (TP) in an in-plane approach. These are recognizable as flat, squared-off acoustic shadows with only a very faint image of the pleura visible. After correct TP identification, an 22-gauge echogenic needle (Pajunk E-Cath, Pajunk Medical Systems) is inserted using an in-plane, cranial-to-caudal approach to contact the bony shadow of the TP with the tip deep to the fascial plane of the erector spinae muscle. The correct location of the needle tip is confirmed by injecting 0.5-1 ml of normal saline 0.9% and observing linear fluid spread lifting the erector spinae muscle off the tip of the TP. Once the fascial plane is recognized, 20 mL of ropivacaine 0.5% is injected and cranial and caudal spread of local anesthetic can be visualized. Anticipated outcomes and measures: The primary outcome is the Quality of Recovery (via QoR-15) total score (Hypothesis 1). This will be measured via QoR-15. (At baseline, 24 hrs, 48 hrs and 72 hrs postoperatively). The secondary outcomes are: (a) The intensity of postoperative pain (Hypothesis 2). Pain will be measured by Visual Analog Scale (VAS) at rest and movement once a day using categorical pain scoring system. (At baseline, 24 hrs, 48 hrs and 72 hrs postoperatively). (b)Opioid consumption (Hypothesis 3) Total opioid consumption will be measured as 24-hour PCA usage each day up to 3 days postoperatively, i.e. postoperatively at 24, 48, 72 hours. (c) Opioid related side effects (hypothesis 4): The side effects of opioids will be measured using Opioid-related symptom Distress Scale (ORSDS). (At baseline, 24 hrs, 48 hrs and 72 hrs postoperatively). (d) The hospital LOS (Hypothesis 5) (In hours). Statistical analysis: The data will be analyzed based on the intention-to-treat principle. The baseline patients' characteristics will be descriptively compared between intervention and control groups according to the suggestion of the CONSORT statement. The primary outcome, total score of QoR15, will be compared between the two groups using student t test. Secondary outcomes, including the subscales of QoR15, such as physical well-being score and Mental well-being, and score, opioid consumption, opioid-related side effects and, the hospital length of stay (LOS) will be compared between two groups using student t test or Wilcoxon rank sum test as appropriate for continuous outcome and chi-square test for categorical outcomes. Repeated measurement outcomes (i.e. pain scores) will be compared between two groups using mix-effect model for repeated measures. Multivariable generalized linear regression model will be further conducted to compare the outcomes between two groups adjusted for the baseline characteristics if applicable. SAS 9.4 (SAS institute Inc. Cary) will be used for the data management and all statistical analysis. A two-sided p-value of <0.05 will be considered statistical significance.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Adults (18-85 years old) diagnosed with IBD
  2. ASA physical status I-III
  3. IBD abdominal laparoscopic assisted surgeries under general anesthesia

Exclusion criteria

  1. Unable to communicate in English
  2. Unstable requiring emergency surgery
  3. Open laparotomies
  4. Morbidly obese
  5. Pregnant
  6. On chronic opioid treatment
  7. Known allergies to local anesthetics
  8. Altered mental status
  9. Concomitant injuries.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 2 patient groups, including a placebo group

Intervention group
Active Comparator group
Description:
Ultrasound guided bilateral ESP block either with local anesthetic
Treatment:
Drug: Ropivacaine
Control group
Placebo Comparator group
Description:
Ultrasound guided bilateral ESP block either with normal saline
Treatment:
Drug: normal saline

Trial contacts and locations

1

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Central trial contact

Siddiqui

Data sourced from clinicaltrials.gov

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