Clinical trial NCT06798103: Comparing Perioperative Analgesia After Ultrasound Guided Bilateral Erector Spinae Plane Block and Thoracic Paravertebral Block in Laparoscopic Sleeve Gastrectomy Patients
Official title: Comparative Study Between Efficacy of Ultrasound-Guided Bilateral Erector Spinae Plane Block and Thoracic Paravertebral Block on Perioperative Analgesia and Fast Recovery of Patients Undergoing Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Laparoscopic Sleeve Gastrectomy (LSG)
Erector Spinae Plane Block
Thoracic Paravertebral Block
Keywords: Laparoscopic Sleeve Gastrectomy (LSG)
Erector Spinae Plane Block
Thoracic Paravertebral block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of ultrasound-guided bilateral erector spinae plane block and thoracic paravertebral block on perioperative analgesic control for 24 hours postoperative and fast recovery of patients undergoing laparoscopic sleeve gastrectomy using the Visual Analogue Scale.

Detailed description: Obesity was ranked as the 5th preventable cause of death and is associated with certain diseases as non-insulin dependent diabetes mellitus, hypertension, ischemic heart disease, hyperlipidemia, and sleep apnea. Egypt has the world's 18th highest obesity prevalence, according to the World Health Organization (WHO).

Bariatric surgery has been advocated for adults with severe obesity for weight reduction purposes and lowering the health risks linked to obesity. Laparoscopic sleeve gastrectomy (LSG) is considered an efficient approach to bariatric surgery which provides an apparent weight loss and an improved weight-related quality of life with reduced postoperative morbidity but is frequently complicated by moderate to severe pain especially in the immediate postoperative period.

The Enhanced Recovery After Surgery (ERAS) recommendations for bariatric surgery currently advocate the utilization of regional anesthesia techniques, which constitute a valuable component of opioid sparing multimodal analgesia strategies to reduce intraoperative and postoperative narcotics consumption. Poorly controlled postsurgical pain is linked to decreased quality of care, surgical complications, prolonged immobility, rehabilitation and hospitalization, development of chronic pain, higher treatment costs, and a heavy burden on the healthcare system.

In 2016, the ultrasound (US)-guided erector spinae plane block (ESPB) was first described to treat thoracic neuropathic pain. The ESPB local anesthetic injectant into the fascial plane deep to the erector spinae muscle with craniocaudal distribution has an analgesic impact on somatic and visceral pain. It causes both somatic and visceral sensory blockade via acting on the ventral and dorsal rami of spinal nerves. The ESPB can provide analgesia to abdominal operations performed at a lower thoracic vertebral level (T7 or T8). However, the main concern with the ESPB is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.

Thoracic paravertebral block (TPVB) is a classic trunk block with definite analgesic effect for both somatic and visceral pain through injecting local anaesthetic alongside the thoracic vertebrae and close to where the spinal nerves emerge from the intervertebral foramen. It produces ipsilateral, somatic and sympathetic nerve blockade in multiple contiguous thoracic dermatomes that culminate in high-quality afferent nociceptive blockade. Despite its wide use in thoracic procedures, to date, few studies have assessed the effectiveness of Thoracic paravertebral block (TPVB) in laparoscopic abdominal surgeries in an adult population.

Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid consumption and length of hospital stay in patients undergoing laparoscopic sleeve gastrectomy.

Eligibility criteria: Inclusion Criteria:

1. Age: 21 to 60 years.
2. Sex: males and females
3. Patients with American Society of Anesthesiologists physical status 4.classifications II-III undergoing laparoscopic sleeve gastrectomy under general anaesthesia.

Exclusion Criteria:

1. Patient refusing to participate in the study.
2. Patients with bleeding disorders.
3. A history of relevant local anaesthetic allergy.
4. Patients with muscle diseases.
5. Evidence of local infection at site of injection.
6. Pre-existing chronic pain or cognitive dysfunction (which would impede accurate engagement with postoperative quality of recovery and analgesia assessment)

Primary outcomes:
measure: Time to first Rescue Analgesia
timeFrame: Postoperative pain will be assessed using Visual Analogue Scale at rest (VAS-R) and with movement (VAS-M) at 30 minutes postoperative and 2, 4, 6, 8, 12, and 24 hours after surgery and Meperidine will be given accordingly.
Secondary outcomes:
measure: mean Meperidine consumption
timeFrame: 24 hours postoperatively
measure: Heart rate
timeFrame: 24 hours postoperatively
measure: Visual Analogue Scale for pain
timeFrame: Postoperative pain will be assessed using Visual Analogue Scale at rest (VAS-R) and with movement (VAS-M) at 30 minutes postoperative and 2, 4, 6, 8, 12, and 24 hours after surgery.
measure: Time to perform the block
timeFrame: Time needed to perform the block intraoperative before induction of general anaesthesia will be recorded.
measure: Time to first ambulation
timeFrame: 24 hours postoperatively
measure: Systolic, Diastolic and Mean arterial blood pressures
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, Ain Shams University
name: Farouk Kamaleldin Abdelaziz, MD, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: