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Postoperative PainNCT04915521

Erector Spinalis Plane Block in Bariatric Surgery

A study testing erector spina plane block (ESPB) group in people with Postoperative Pain and Opioid Consumption, run by Meliha Orhon at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Postoperative Pain, Opioid Consumption
What is being tested?
erector spina plane block (ESPB) group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jan 2020to 10 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
  • patient does not provide consent or withdraws consent at any point after inclusion.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul, Maltepe, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Ultrasound-guided Erector Spinalis Plane Block on Postoperative Pain and Intraoperative Opioid Consumption in Bariatric Surgery

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.

Read the detailed description

Obesity represents a major disease burden and healthcare challenge globally due to its increasing prevalence over the last decades. From 1980 to 2013, worldwide prevalence of overweight/obesity increased by 27·5% for adults and 47·1% for children, resulting in an estimated global total number of obese/overweight individuals slightly more than two billion. Obesity is associated with serious conditions including cardiovascular disease, diabetes, some cancers, kidney disease, sleep apnea, gout, osteoarthritis, hepatobiliary disease, resulting in increased mortality and decreased life expectancy among obese individuals. On the other hand, weight loss leads to improvement of these conditions and outcomes. Life-style modifications with diet, exercise, and behavioral therapy, pharmacotherapy, and surgery are used for the management of obesity. Bariatric surgery represents an effective and a sustainable treatment modality in patients with morbid obesity, laparoscopic sleeve gastrectomy and gastric bypass being the most common procedures. However, these procedures are mostly associated with moderate to severe postoperative pain, which is often a combination of abdominal wall pain and visceral pain.Postoperative pain, when not adequately controlled, has unfavorable consequences such as impaired quality of life and recovery as well as increased risk of surgical complications and persistent postsurgical pain. Patients with morbid obesity represent a special group when it comes to perioperative pain management. These patients have a higher incidence of sleep-disordered breathing; therefore, opioids have the potential to induce ventilatory impairment resulting in increased morbidity/mortality. Stepwise and severity based-multi-modal analgesia with opioid-sparing approach can improve safety; thus, Enhanced Recovery After Surgery (ERAS) guidelines for bariatric surgery currently recommend opioid reduction in bariatric surgery. Both systemic analgesics and regional approaches such as transversus abdominis plane (TAP) block, intraperitoneal and wound modalities, and neuraxial techniques are being used for postoperative pain control in bariatric surgery with some success.

Ultrasound-guided erector spinae plane block is a novel regional anesthesia technique where local anesthetic agent is injected deep into the erector spinae muscle to the fascial plane and allowed to diffuse in caudal and cranial direction. It has been shown effective in a number of conditions such as thoracic surgery/trauma, painful conditions of the limbs, cardiac surgery, breast surgery, and abdominal surgery. To date, only few studies examined the use of ESPB in bariatric surgery, all indicating potential benefits of the technique in terms of opioid sparing and pain control.

This study aimed to compare bilateral ultrasound-guided erector spinalis plane block technique with controls who received bupivacaine injection to the trocar sites, in terms of intraoperative opioid consumption, postoperative pain control in the first 24 hours, and need for rescue analgesic.

METHODS

Patients Sixty-two patients with morbid obesity who underwent laparoscopic bariatric/metabolic surgery (sleeve gastrectomy or gastric bypass) were included in this randomized study.

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

Exclusion/drop-out criteria were as follows: 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; or patient does not provide consent or withdraws consent at any point after inclusion.

The study protocol was approved by local ethics committee (Ethics Committee for Clinical Studies, Marmara University, Medical Faculty; date, January 3, 2020; number, 09.2020.128).

All patients provided informed consent prior to study entry and the study was conducted in accordance with the Declaration of Helsinki.

Randomization to the study groups Patients were randomly assigned to the erector spina plane block (ESPB) group or the control group using sealed envelopes with 1:1 ratio. ESPB group received ultrasound-guided bupivacaine and lidocaine injection at T9 vertebral level before anesthesia induction. Control group received 5 ml 0.5% bupivacaine injection to each trocar site (total of 25 ml) at the beginning of the operation.

Erector spinalis plane block technique

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 20ml 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.

Intraoperative anesthesia management Anesthesia was induced with propofol 2.5-3.5 mg/kg and 1 mcg/kg bolus dose of remifentanil, which was followed by rocuronium 0.6 mg/kg to aid intubation. Corrected body weight (CBW) was used for the dose adjustment of propofol, and ideal body weight (IBW) was used for the dose adjustments of remifentanil and rocuronium. Total intravenous anesthesia with propofol and remifentanil was used for maintenance and the initial doses were as follows: propofol 6-10 mg/kg/h and remifentanil 0.5 mcg/kg/h. Propofol and remifentanil dose was adjusted to keep BIS between 40 and 45, and ANI between 50 and 70, respectively. Electrocardiography, non-invasive blood pressure, bispectral index (BIS, Medtronic, Mineapolis), and ANI were continuously monitored and recorded at every 30 minutes.

To evaluate perioperative pain and to adjust opioid dose, ANI was continuously monitored throughout the surgical procedure. Two ANI electrodes were placed on the sternum and at the level of left nipple (to the same places with V1 and V5 ECG electrodes, respectively). Total remifentanil dose was recorded for each patient. Depth of anesthesia was monitored to adjust propofol dose using BIS (Aspect Medical Systems, Natick, Mass, ABD).

Fifteen minutes before the completion of the surgical procedure, both groups received 1 g paracetamol and the control group received 150 mg tramadol.

Assessments The primary outcome measure was total intraoperative opioid consumption, and the secondary outcome measure was the change in postoperative pain as assessed by 10-point visual analogue scale (VAS). A blinded investigator recorded self-assessed VAS scores of the patients upon awakening and at 6, 12, and 24 hours. In case VAS ≥ 4, rescue analgesic was given (100 mg tramadol). Timing of first analgesic requirement was recorded.

Statistical analysis Data were analyzed using SPSS (Statistical Package for Social Sciences) version 21 software. Mean ± standard deviation or median (range) was used to express descriptive data. Both hypothesis tests and graphical method were used to test the distribution of continuous variables. Student t test for independent samples or Mann-Whitney U test was used to test between-group differences. Fisher's exact test was used to compare the two groups in terms of complication frequencies. Two-way ANOVA test for repeated measurements was used to examine the significance of differences between groups in postoperative VAS scores and intraoperative measurements over time. Two-sided p values \<0.05 were considered indication of statistical significance.

Being tested
erector spina plane block (ESPB) group
Keywords
bariatric surgery, morbid obesity, ultrasound-guidance, erector spinalis plane block (ESPB), visual analogue scale (VAS) score, opioids
Medical subject headings
Pain, Postoperative, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erector spina plane block (ESPB) groupOther

    Also called non-block control group

    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.

Study groups in NCT04915521
Study groupRoleWhat they receive
erector spinae plane block groupActive comparatorESPB group received ultrasound-guided bupivacaine and lidocaine injection at T9 vertebral level before anesthesia induction.
Receives: Other: erector spina plane block (ESPB) group
non block control groupNo interventionControl group received 5 ml 0.5% bupivacaine injection to each trocar site (total of 25 ml) at the beginning of the operation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total intraoperative opioid consumption,

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

    Measured: postoperatif first 24 hours

Secondary outcomes (1)
  1. measure vas the change in postoperative pain

    measure vas the change in postoperative pain as assessed by 10-point visual analogue scale (VAS).

    Measured: up to 6, 12, and 24 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2021
  2. Study start10 Jan 2020
  3. Primary completion3 Jan 2021
  4. Study completion10 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04915521
Sponsor's protocol ID
09.2020.128
Status last verified
Jun 2021
First submitted
19 Apr 2021
Last updated
7 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing erector spina plane block (ESPB) group in people with Postoperative Pain and Opioid Consumption, run by Meliha Orhon at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total intraoperative opioid consumption, (time frame: postoperatif first 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.

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