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Comparison Between Retrolaminar Block Combined With Erector Spinae Plane Block, and Erector Spinae Plane Block Alone for Post-thoracotomy Pain

Comparison Between Retrolaminar Block Combined With Erector Spinae Plane Block, and Erector Spinae Plane Block Alone for Post-thoracotomy Pain

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05791539
Enrollment
32
Registered
2023-03-30
Start date
2023-02-02
Completion date
2023-11-30
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-thoracotomy Pain Syndrome

Brief summary

Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post thoracotomy pain

Detailed description

Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The surgical incision produces post-thoracotomy pain (PTP) via damage to the ribs and intercostal nerves, inflammation of the chest wall, pleura or pulmonary parenchyma cutting, and placement of the intercostal chest tube. Acute PTP inhibits the ability to breathe and cough normally. Numerous analgesic techniques are used to relieve PTP, including systemic opioids, regional techniques (such as paravertebral nerve blockade, intercostal nerve blockade, intrapleural analgesia, and epidural opioids with or without local analgesia), cryo-analgesia, and transcutaneous electrical nerve stimulation (TENS). Emerging research has shown that the novel erector spinae plane block (ESPB) can be employed as a simple and safe alternative analgesic technique for acute post-surgical, post-traumatic, and chronic neuropathic thoracic pain in adults. ESPB was first reported in 2016 for ipsilateral thoracic analgesia. It was found to be a safe and effective block that can be performed by an emergency physician in the emergency department setting for addressing acute pain due to multiple rib fractures. Retrolaminar block (RLB) was first reported in 2006 as an alternative approach to PVB. RLB is performed with US imaging or the landmark technique. The efficacy of continuous RLB has been reported for breast cancer surgery . However, the efficacy of ESPB has been described in a greater number of clinical reports than has RLB: a rib fracture, breast surgery, thoracoscopic surgery, lumbar spinal surgery, and laparoscopic abdominal surgery. In contrast to RLB, most of the literature on ESPB reported the use of the single-shot technique (80.2%). The local anesthetic was postulated to infiltrate the ventral and dorsal rami of the spinal nerve. However, Ueshima et al. reported that ESPB could not provide adequate analgesia of the anterior branch of the intercostal nerve. The rationale of the study is that to the best of our knowledge each of ESPB and RLB has limitations regarding sensory block and distribution so our hypothesis is combining both will provide more solid block regarding sensory distribution, time interval of the block efficacy, and postoperative morphine consumption in patients undergoing thoracic surgeries. Few studies evaluated the efficacy of ultrasound (US) guided erector spinae plane block on post-thoracotomy analgesia, however for the best of our knowledge no one compared the effect of ultrasound (US) guided retrolaminar block combined with erector spinae plane block and ultrasound (US) guided erector spinae plane block alone in patients undergoing thoracic surgeries.

Interventions

PROCEDUREErector spinae plane block

Patients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA.

PROCEDUREerector spinae plane block + retrolaminar block

Patients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Randomization will be accomplished through the use of computer-generated random numbers and closed opaque envelopes. Another anesthesiologist who will not be involved in the other parts of the study will open the envelopes to enroll patients. and both patients and outcome assessors will be blinded to the assignment of groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 1\. Inclusion criteria * Age from 18-65 years. * body mass index (BMI) ranged between 20 and 40 kg/m2 * ASA I, II patients undergoing open thoracic surgery through a posterolateral thoracotomy 2.

Exclusion criteria

* Patient refusal. * Sensitivity or contraindication to local anesthetic drugs. * History of psychological disorders and/or chronic pain. * Localized infection at the site of the block. * Coagulopathies, patients on anticoagulants and antiplatelets, and significant liver or renal insufficiency

Design outcomes

Primary

MeasureTime frameDescription
Total amount of morphine consumption in the first 24-hour postoperative in the two groups.24 hours20ml for ESPB compared to 10ml ESPB added to 10ml RLB.

Secondary

MeasureTime frameDescription
•Pain score according to VAS score24 hoursPain score according to VAS score at 30min, 2h, 4h, 8h, 12h, 24h postoperative.
• Heart rateintraoperative• Heart rate(Bpm) at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.
Incidence of complications24 hours•Incidence of complications as hypotension, bradycardia, postoperative nausea, vomiting (PONV) and pruritis.
.First request of analgesia postoperative24 hoursfirst time to request analgesia in the first 24 hrs
MAPintraoperativeMean arterial blood pressure in mmhg at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.

Countries

Egypt

Contacts

Primary Contactsherif mamdouh, MD
s25041989@hotmail.com01141235049

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026