Comparing Perioperative Analgesia After Ultrasound Guided Bilateral Erector Spinae Plane Block and Thoracic Paravertebral Block in Laparoscopic Sleeve Gastrectomy Patients

NCT06798103 | Completed DMC

• 1 other identifier: FMASU MD335/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Sleeve Gastrectomy (LSG); Erector Spinae Plane Block; Thoracic Paravertebral Block

Keywords

Laparoscopic Sleeve Gastrectomy (LSG); Erector Spinae Plane Block; Thoracic Paravertebral block

Outcome Measures

Primary Outcomes (1)

• Time to first Rescue Analgesia

  25 mg IV Meperidine (Pethidine) will be given as a rescue analgesia if patients complained of postoperative pain and their Visual Analogue Scale for pain ≥ 3 and to be repeated if patients continue to complain. Time to first rescue analgesia will be recorded. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient will be asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark defines the subject's pain. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]).

  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 (6)

• mean Meperidine consumption

  24 hours postoperatively

• Heart rate

  24 hours postoperatively

• Visual Analogue Scale for pain

  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.

• Time to perform the block

  Time needed to perform the block intraoperative before induction of general anaesthesia will be recorded.

• Time to first ambulation

  24 hours postoperatively

Study Arms (2)

Erector spinae plane block group (ESPB)

ACTIVE COMPARATOR

Group (I): 15 participants will be injected with 30 mL of 0.25% bupivacaine deep to the erector spinae muscle.

Procedure: Erector Spinae Plane Block

Thoracic paravertebral block group (TPVB)

ACTIVE COMPARATOR

Group (II): 15 participants will be injected with 25 ml of 0.25% bupivacaine into paravertebral space of T7 vertebra.

Procedure: Thoracic paravertebral block

Interventions

Erector Spinae Plane Block PROCEDURE

Erector spinae plane block will be performed using an ultrasound machine with a high frequency linear probe. The patients will be in sitting position to perform the block, the skin is sterilized and the transducer will be placed across the T7 spinous process then move laterally to identify transverse process of T7. Thereafter, the probe will be moved to a parasagittal plane to visualize skin and subcutaneous tissue layers, trapezius muscle, and lastly the erector spinae muscle just superficial to the transverse processes. The in-plane technique will be used, and the tip of the needle will be inserted in the fascial plane deep to the erector spinae muscle. After 2-3 mL of normal saline injection for hydro dissection to verify the correct needle tip placement, 30 mL of 0.25% bupivacaine will be injected deep to the erector spinae muscle. The same technique will be repeated on the contralateral side.

Also known as: ESPB

Erector spinae plane block group (ESPB)

Thoracic paravertebral block PROCEDURE

Thoracic paravertebral block will be performed using an ultrasound machine with a high frequency linear probe. The patients will be in sitting position to perform the block, the skin is sterilized and the transducer will be placed across the T7 spinous process then move laterally to identify transverse process of T7. Thereafter, the probe will be moved 3-5 cm laterally to identify the paravertebral space as the target injection site. After probe being rotated into transverse orientation, the needle will be inserted using the out-plane technique. Once the needle threads the internal intercostal membrane and arrives in the paravertebral space, 3 ml of normal saline will be injected firstly. If displacement sign of the pleura occurs, 25 ml of 0.25% bupivacaine will be then injected into the confirmed paravertebral space. The same technique will be repeated on the contralateral side.

Also known as: TPVB

Thoracic paravertebral block group (TPVB)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams University hospitals

Cairo, 02, Egypt

Location

Study Officials

• Farouk Kamaleldin Abdelaziz, MD, Lecturer

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 29, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)