A Phase 4 interventional study of General Anesthesia (GA) and Rhomboid Intercostal Block in Retrolaminar Block and Intercostal Nerve Block, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
Retrolaminar block (RLB)(a modified form of paravertebral block (PVB) and The ultrasound-guided rhomboid intercostal block (UG-RIB) used to alleviate the postoperative pain in video assisted thoracic surgery (VATS). We hypothesized that RLB may offer superior analgesic coverage and efficacy compared to The ultrasound-guided rhomboid intercostal block (UG-RIB) in the context of VATS.
1. INTRODUCTION/ REVIEW (Maximum 1000 words) "References are needed" Thoracic surgery is specialized in the study of the chest organs and mainly refers to the lung, esophagus, and mediastinum diseases diagnosis and treatment, such as chest trauma, lung tumors, esophageal tumors, chronic obstructive emphysema, tuberculosis, esophageal functional diseases, diaphragmatic diseases, and congenital diseases of the chest. So many patients need to be treated with thoracic surgery in the world. Compared to thoracotomy, video-assisted thoracic surgery (VATS) has similar therapeutic effects with less invasion and relieves postoperative pain significantly, promoting rehabilitation [1-3].
However, the VATS still causes moderate to severe postoperative pain [4, 5]. Postoperative analgesia is a critical issue in accelerating the rehabilitation of patients during the perioperative period. The thoracic epidural block (TEB) is the gold standard for analgesia for thoracic surgery. However, the complications such as hypotension and nerve injury caused by it have been a problem that cannot be ignored.(6) RLB is a modified form of paravertebral block (PVB) [7]. While PVB is increasingly used for chest and abdominal surgeries due to its precise analgesic effects, it carries a risk of serious complications, including pneumothorax, hypotension, or nerve damage [8,9]. Even with ultrasound guidance, performing a traditional PVB remains technically challenging, with its success heavily reliant on the operator's expertise. RLB, as an improved alternative to PVB, has received growing attention in recent years. It involves the ultrasound-guided injection of local anesthetic between the lamina of the thoracic vertebra and the erector spinal muscle [10]. Compared to PVB, RLB is easier to perform, associated with fewer complications such as pneumothorax, intrathecal injection, or vascular damage. However, the spread of anesthetic in RLB appears highly variable and is dose-dependent [11,12].
The ultrasound-guided rhomboid intercostal block (UG-RIB) was discovered by Elsharkawy et al. in 2016 [13]. It has been reported that UG-RIB can ensure adequate analgesia in modified radical mastectomy and VATS [14, 15]. However, a comparison of the analgesic efficacy between RIB and retrolaminar (RLB)has yet to be reported. Therefore, it is urgent to compare the clinical effects of RIB and RLB in alleviating acute pain following video-assisted thoracic surgery to provide a scientific and practical theoretical foundation for selecting a subsequent analgesic strategy. It is of great significance to improve patients' life and rehabilitation and avoid other complications after the operation.
- Inclusion Criteria:
written informed consent was obtained.
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Study Procedures : All patients will be taught how to interpret the visual analogue scale (VAS) of 0 to 10 with 0 experiencing no pain and 10 being the worst pain imaginable. All patients will fast for 8 hours prior to surgery and will be allowed to consume clear fluids for up to 2 hours before surgery. On the day of surgery. Basic monitors will be attached to the patients (NIBP, ECG, pulse oximetry, ETCO2).
Both ultrasound guided blocks will be done by experienced anesthesiologists specialized in regional anesthesia.
The patient will be kept in the lateral decubitus position. Following sterilization and draping of the skin, a high frequency ultrasound probe (Siemens Medical Solutions, Inc., Mountain View, CA 94043, USA) will be used For RLB, the ultrasound probe will be placed in a sagittal orientation on the lateral side of the posterior median line to identify the lamina, erector spine muscle, and transvers spinalis muscles at the target thoracic segment [12]. A 20G puncture needle will be inserted using an intra-plane technique in a cephalocaudal direction. Once the needle contact the lamina and aspiration reveals with no blood, gas, or cerebrospinal fluid, 20 mL of local anesthetic solution, comprising 20 mL of 0.25% bupivacaine will be administered between the transvers spinalis muscle and lamina.
The patient was kept in the lateral position, and the ipsilateral arm was extended to move the scapula laterally and open the space. The skin was sterilized and draped, followed by the placement of a linear probe (Siemens Medical Solutions, Inc., Mountain View, CA 94043, USA) in an oblique sagittal plane medial to the lower border of the scapula, the triangle of auscultation, at the level of the T5 to T6 vertebrae. The rhomboid major muscle is located beneath the trapezius muscle. The pleura, lungs and intercostal muscles were also identified [18]. Using an in-plane approach, a 22-gauge, 80 mm stimuplex needle was placed in the craniocaudal direction into the fascial plane between the rhomboid major and the inter costal muscles. The needle tip position was confirmed via hydrodissection with 1 ml of normal saline, after which 20 ml of 0.25% bupivacaine was injected underneath the rhomboid major muscle.
Participants of the two interventional groups under went sensory assessment using standardized cold sensation test with iced solutions every 5 min for 30 min after injecting LA. The data was recorded as the area of sensory loss at the midclavicular line (MCL), midaxillary line (MAL)and at scapular line (SL)compared to the ipsilateral shoulder's intact sensibility.
A block was considered successful if at least three dermatomes from T3-T6 at MAL and MAL, were covered bilaterally; otherwise, a failed block was declared after 30 min of LA injection, and this case was withdrawn from the study. The onset time of the block (from injecting LA until achieving the desired successful sensory level) and its maximum dermatomal level were recorded. An assistant who was not involved in the block performance or the following study steps conducted a block assessment
Anesthesia induction and nerve blocks for all patients were performed by a group of independent experienced anesthesiologists in the preanesthesia room according to the random number before the operation (the GA group, only performed induction). Afterwards, the patients were transferred to the operating room to start the operationThe postoperative analgesia regimen comprises an ibuprufen and patient-controlled intravenous naluphen. Postoperative VAS scores, consumption of opioids were documented to estimate the analgesic effect.
Anesthesia Introduction and Maintenance will be done by propofol until loss of verbal response, atracurium (0.5 mg/ kg), fentanyl (1mic/kg). Intubation of trachea will be done. Maintenance of anesthesia by using isoflurane (MAC1.2-1.5), mechanical ventilation (to keep ETCO2 35-40 mm. Hg), and atracurium top-up doses according to the train of four (TOF).
After that arterial cannula will be inserted with monitoring of invasive arterial blood pressure All patients will be given fluids according to the standardized guidelines. An appropriate type of antibiotics and paracetamol (15 mg/kg) will be given at the start of surgery. Ondansetron IV (4-8 mg) and ketorolac IV (30 mg) will be given at the end of surgery.
Heart rate (HR) and mean arterial blood pressure (MAP) will be measured until the end of surgery. Incremental doses of fentanyl were given if inadequate anal gesia was detected (increased HR or MAP > 20% from baseline values) after exclusion of other causes. The total dose of fentanyl consumed intraoperatively will be recorded.
Surgical Management Patients in the three groups were scheduled for wedge resection, segment resection, and lobectomy, which were determined by preoperative chest CT and intraoperative pathological results. All operations were performed by the same group of surgeons. All surgical procedures were completed by video-assisted thoracic surgery (VATS) with two ports. The trochal ports were made at the fourth/seventh intercostal levels.
All the resection material was removed by a surgical glove without excessive expansion of the incision. A chest drain (22F) was inserted at the seventh intercostal level before the skin closure. When suturing the wound, carefully identify the position of the intercostal nerve to avoid injuring the intercostal nerve. No wound retractor was used during the operation.
Reversal of muscle relaxant will be done by using neostigmine (0.07 mg/kg) and atropine (0.01 mg/kg) and extubate the patient when having the criteria of extubation. Patients then will be transferred to the post- anesthesia care unit (PACU) for 2 hr for observation of any complications and early assessment of pain then will be transferred to the ward.
. Pain Management all patients in the surgical ward received 200 mg celecoxib orally twice daily and paracetamol 1 gm/8 hours (maximum dose: 4 g/day) as standard postoperative analgesics. Rescue analgesia in the form of 0.1 mg/kg IV of nalbuphine was injected if the patient reported VAS score of ≥ 3 or was asked for more analgesia according to the VAS score during the first 24 h after surgery (the maximum single dose was 20 mg, and the maximum daily dose was 160 mg).
2.4. Outcome Measures The primary outcome The 1st rescue analgesic time was the time it took to request the first postoperative analgesic (nalbuphine) from the end of surgery until the patient reported a VAS score of ≥ 3.
The secondary outcomes include
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECEIVED GENERAL ANAESTHESIA IN VIDEO ASSISSTED THORACOCOSCOPIC SURGERY
Other: General Anesthesia (GA)
RECEIVED RHOMBOID INTERCOSTAL NERVE BLOCK IN VIDEO ASSISTED THORACOSCOPIC SURGERY
Other: Rhomboid Intercostal Block
RECEIVED RETROLAMINAR BLOCK IN VIDEO ASSISSTED THORACOSCOPIC SURGERY
Other: Retrolaminar block group
will be done by propofol until loss of verbal response, atracurium (0.5 mg/ kg), fentanyl (1mic/kg). Intubation of trachea will be done. Maintenance of anesthesia by using isoflurane (MAC1.2-1.5), mechanical ventilation (to keep ETCO2 35-40 mm. Hg), and atracurium top-up doses according to the train of four (TOF). After that arterial cannula will be inserted with monitoring of invasive arterial blood pressure All patients will be given fluids according to the standardized guidelines. An appropriate type of antibiotics and paracetamol (15 mg/kg) will be given at the start of surgery. Ondansetron IV (4-8 mg) and ketorolac IV (30 mg) will be given at the end of surgery.
The patient was kept in the lateral position, and the ipsilateral arm was extended to move the scapula laterally and open the space. The skin was sterilized and draped, followed by the placement of a linear probe (Siemens Medical Solutions, Inc., Mountain View, CA 94043, USA) in an oblique sagittal plane medial to the lower border of the scapula, the triangle of auscultation, at the level of the T5 to T6 vertebrae. The rhomboid major muscle is located beneath the trapezius muscle. The pleura, lungs and intercostal muscles were also identified \[18\]. Using an in-plane approach, a 22-gauge, 80 mm stimuplex needle was placed in the craniocaudal direction into the fascial plane between the rhomboid major and the inter costal muscles. The needle tip position was confirmed via hydrodissection with 1 ml of normal saline, after which 20 ml of 0.25% bupivacaine was injected underneath the rhomboid major muscle
For RLB, the ultrasound probe will be placed in a sagittal orientation on the lateral side of the posterior median line to identify the lamina, erector spine muscle, and transvers spinalis muscles at the target thoracic segment \[12\]. A 20G puncture needle will be inserted using an intra-plane technique in a cephalocaudal direction. Once the needle contact the lamina and aspiration reveals with no blood, gas, or cerebrospinal fluid, 20 mL of local anesthetic solution, comprising 20 mL of 0.25% bupivacaine will be administered between the transvers spinalis muscle and lamina.
The 1st rescue analgesic
time was the time it took to request the first postoperative analgesic (nalbuphine) from the end of surgery until the patient reported a VAS score of ≥ 3.
Time frame: FIRST 24 HOURS
The total dose of nalbuphine,
a rescue analgesic, was taken during the first 24 hours after surgery
Time frame: 24 HOURS
The visual analogue scale (VAS) scor
VAS) score was assessed at rest and during movement (arm movement of 90° and sitting from the lying down position) at PACU, 1 h, 3 h, 6 h, 12 h, and 24 h postoperatively.
Time frame: FIRST 24 HOURS
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