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Erector Spinae BlockNCT07624058

Erector Spina Plane Block Versus Modified Thoracoabdominal Nerve Block After Laparoscopic Cholecystectomy

A study testing bilateral ESP block and bilateral M-TAPA block in people with Erector Spinae Block and Modified Thoracoabdominal Nerve Block, run by Alexandria University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

direct comparisons between ESPB and M-TAPA for postoperative analgesia after LC remain limited. This is an important area of clinical interest because the two blocks differ significantly in their anatomical targets, mechanism of analgesia, and likely dermatomal coverage. Read more about this study

Who is it for?
Ages 30 to 65 years
What is being tested?
bilateral ESP block and bilateral M-TAPA block
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Apr 2026to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: between 30 - 65
  • American Society of Anaesthesiologists physical status: I- III
  • Body mass index: 18-35 kg.m-2

Who cannot join

  • Patient Refusal
  • Allergy to local anaesthetic agents.
  • Skin infection at the site of injection.
  • Coagulopathy.
  • Diabetes Mellitus

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

sarah m elgamal, MD contact

01005496440

sarahelgamal1990@yahoo.com

Egypt1 site, 1 recruiting
  • Alexandria University

    Alexandria

    sarah m elgamal, MD, 01005496440, sarahelgamal1990@yahoo.com

    sarah m elgamal, MD

    Recruiting

Other trials in Egypt

About this study

Official title: Erector Spinae Plane Block Versus Modified Thoracoabdominal Nerve Block For Pain Control After Laparoscopic Cholecystectomy

direct comparisons between ESPB and M-TAPA for postoperative analgesia after LC remain limited. This is an important area of clinical interest because the two blocks differ significantly in their anatomical targets, mechanism of analgesia, and likely dermatomal coverage. The ESPB provides analgesia through paravertebral spread affecting both dorsal and ventral rami, thereby offering posterior and visceral pain relief, whereas M-TAPA directly targets the thoracoabdominal nerves, resulting in better anterior and lateral abdominal wall analgesia. Understanding which technique offers superior or more balanced analgesia could help to optimise regional anaesthesia strategies in LC and to improve patient outcomes.

Read the detailed description

Laparoscopic cholecystectomy (LC) has largely replaced open cholecystectomy as the standard surgical treatment for symptomatic gallbladder disease. The minimally invasive approach is associated with significantly less postoperative pain, shorter hospital stay, faster return to normal activity, lower risk of wound infection, and better cosmetic results. (1,2) Despite these advantages, many patients still experience moderate to severe pain in the early postoperative period. This pain results from a combination of somatic pain at trocar insertion sites, visceral pain due to gallbladder bed irritation, and referred shoulder pain from diaphragmatic stretching caused by pneumoperitoneum. (3) Effective postoperative pain control is crucial not only to improve patient comfort but also to reduce opioid consumption, facilitate early ambulation, and decrease postoperative pulmonary complications. (4) Traditionally, postoperative analgesia following LC has relied on multimodal regimens including systemic non-steroidal anti-inflammatory drugs (NSAIDs), opioids, port-site local infiltration, and intraperitoneal local anaesthetic instillation. (5) While opioids remain an important analgesic option, their side effects-such as nausea, vomiting, respiratory depression, pruritus, and delayed recovery-can adversely affect the quality of postoperative recovery. (6) Consequently, there has been increasing interest in the use of ultrasound-guided regional anaesthetic techniques as part of multimodal analgesia to improve pain control and reduce opioid requirements after LC.

Among these regional approaches, the erector spinae plane block (ESPB) has gained significant attention in recent years. The ESPB involves injecting local anaesthetic into the fascial plane deep to the erector spinae muscle, typically at a thoracic vertebral level. This allows cranio-caudal spread and potential diffusion into the paravertebral and epidural spaces, resulting in both visceral and somatic analgesia across multiple dermatomes. (7) 4. It was found that bilateral Erector Spinae Plane Block has shown promising benefits for postoperative analgesia after laparoscopic cholecystectomy which includes, reduction in postoperative pain scores, reduced opioid requirements, improved recovery and improved postoperative respiratory function and these findings highlight ESPB as an effective, safe and easy to perform block for postoperative analgesia after laparoscopic cholecystectomy. (8) A newer alternative regional technique is the Modified Thoracoabdominal Nerve Block through the Perichondrial Approach (M-TAPA). First described by Tulgar et al., this block targets the anterior and lateral cutaneous branches of the thoracoabdominal nerves (T5-T12) by depositing local anaesthetic in the perichondral plane beneath the costal cartilage. (9) Its theoretical advantage lies in providing both anterior and lateral abdominal wall analgesia, which corresponds well to the sites of trocar insertion in LC. Early evidence has been promising and demonstrated that bilateral M-TAPA significantly reduced postoperative pain scores. M-TAPA significantly reduced 24-hour opioid consumption and decreased the incidence of postoperative nausea and vomiting and also shortened hospital stay and improved patient satisfaction following LC.

AIM OF THE WORK To compare the analgesic efficacy of the Erector Spinae Plane Block (ESPB) versus the Modified Thoracoabdominal Nerve Block through the Perichondrial Approach (M-TAPA) for postoperative pain control in patients undergoing laparoscopic cholecystectomy under general anaesthesia.

Primary outcome:

Time to First Analgesic request.

Secondary outcomes:

  1. Total Nalbuphine consumption.
  2. Visual analogue score (VAS) in the first 24 hours after surgery.
  3. Patient satisfaction.
  4. Quality of postoperative recovery (QOR 15).
  5. Incidence of complications or adverse events.

PATIENTS After approval of the Medical Ethical Committee of the Faculty of Medicine, Alexandria University and having an informed written consent from every patient included in this study, the present study will be carried out in Alexandria University Main Hospital on 50 patients aged between 30 and 65 years, of both sexes, belonging to American Society of Anesthesiologists classes I-III who are scheduled for laparoscopic Cholecystectomy. The study will be designed as a double-blinded, single-center prospective, randomized comparative design. The sample size is approved to be sufficient by the department of statistics, Medical Research Institute, Alexandria University.

By using SPSS program version 28, (12) A minimal total sample size of (34) patients undergoing laparoscopic cholecystectomy (17) per group is needed to detect an assumed difference of (1) (13) in mean visual analogue scale (VAS) between a group of patients receiving erector spinae plane block with an assumed mean of (2.4±1.1) vs another group receiving modified thoracoabdominal nerve block with an assumed mean of (1.4±0.9) to evaluate the efficacy of both procedures regarding pain control after laparoscopic cholecystectomy using independent t test with a significance level of (0.05) and 80% power.

Patient grouping and randomization:

Patients will be randomized by sealed envelope technique into two equal groups (25 patients each):

Group (1): Twenty-five patients will receive bilateral ESP block with injection of 20 ml 0.25% bupivacaine.

Group (2): Twenty-five patients will receive bilateral M-TAPA block with injection of 20 ml of 0.25% bupivacaine.

METHODS For every patient in the study the following will be done.

Preoperative assessment:

  1. Proper history taking.
  2. Complete clinical examination.
  3. Routine laboratory investigations and any other investigation needed.

Patient preparation:

On arrival to the operative theatre, a 20G intravenous cannula will be inserted in a peripheral vein.

The technique of anaesthesia will be explained to the patients. All patients will be premedicated with midazolam 0.05 mg/kg IV.

Monitoring:

Using a multichannel monitor (mindray patient monitor Model (iMEC10) CHINA), the patients will be monitored for:

  1. Noninvasive arterial blood pressure.
  2. Lead II electrocardiography (for rate and Rhythm).
  3. Pulse oxygen saturation (SpO2 %).
  4. End tidal CO2 (ETCO2). Standardized general anesthesia will then be induced in both groups. Anesthetic technique: Pre-oxygenation will be done for 3 minutes. Induction will be done with propofol 2 mg/kg intravenous (IV), fentanyl 2 μg/kg IV and atracurium 0.5 mg/kg IV to facilitate endotracheal intubation. Then volume control mechanical ventilation will be set, Tidal Volume 8ml/kg of ideal body weight and will be adjusted according to ETCO2 to maintain it between 35-40 mmHg. (15) Anesthesia will be maintained with 1-1.5% Isoflurane in 50% O2 and air. Muscle relaxation will be maintained with atracurium 0.1 mg/kg IV. (16) All patients will receive Dexamethasone (8 mg) intravenously as anti-emetic. (17) Regional anesthetic technique: After induction of general anaesthesia and prior to surgical incision, patients will be positioned for administration of the regional block according to their assigned study group. ● Erector Spinae Plane Block (ESPB) Group o With the patient in the lateral position, using complete aseptic techniques, the T8 spinous process will first be identified in the midline using a high-frequency linear ultrasound probe (Sonosite). The probe will then be moved 2-3 cm laterally to visualize the characteristic hyperechoic shadow of the T8 transverse process, along with the overlying erector spinae muscle. Using an in-plane technique, an 18-gauge block needle will be advanced in a cranio-caudal direction until the needle tip contacts the posterior aspect of the T8 transverse process. The correct needle placement will be confirmed by hydrodissection of the interfascial plane with 2-3 ml of 0.9% normal saline, ensuring separation between the erector spinae muscle and the transverse process. Following confirmation of correct placement, 20 ml of 0.25% bupivacaine will be injected slowly under continuous ultrasound guidance. The spread of local anaesthetic in the fascial plane, extending cranio-caudally between the erector spinae muscle and the transverse processes, will be observed in real time to confirm adequate distribution. The same process will be repeated on the other side. ● Modified Thoracoabdominal Nerve Block (M-TAPA) Group For patients allocated to the M-TAPA group, the procedure will be performed under similar aseptic and ultrasound-guided conditions, using the same type of needle and concentration of local anaesthetic. With the patient in the supine position, the ultrasound probe will be placed transversely over the costal margin at the T8-T9 level, and the perichondrial plane will be identified beneath the costal cartilage. Using an in-plane approach, the needle will be advanced until the tip reaches the desired plane, and correct positioning will be confirmed by hydrodissection with 2-3 ml of 0.9% saline. Subsequently, 20 ml of 0.25% bupivacaine will be injected, with visualization of local anaesthetic spread beneath the costal cartilage confirming proper deposition. The same process will be repeated on the other side. After the completion of surgery, residual neuromuscular blockade will be reversed with neostigmine 0.05 mg/kg and atropine 0.02 mg/kg intravenously. Following full recovery of spontaneous respiration and protective airway reflexes, patients will be extubated and transferred to the post-anesthesia care unit (PACU) for monitoring and postoperative evaluation. ● Post-operative management All patients will receive intravenous paracetamol 1 g every 6 hours, as well as Ketorolac 30 mg every 12 hours as baseline analgesia in the immediate post-operative period. If the VAS score is equal to or greater than 4, rescue analgesia in the form of intravenous nalbuphine 0.1 mg/kg will be administered and recorded. (16,18) Postoperative nausea and vomiting (PONV) will be assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at the same time intervals as pain assessment. If moderate or severe nausea occurs, intravenous ondansetron 4 mg will be administered as rescue antiemetic therapy. Post operative outcomes will be assessed in ward by Doctors who are blinded to patient group assignment and study design.
Being tested
bilateral ESP block, bilateral M-TAPA block
Keywords
pain control, erector spinae block
Medical subject headings
Agnosia

What participants receive

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

  • bilateral ESP blockOther

    bilateral ESP block with injection of 20 ml 0.25% bupivacaine.

  • bilateral M-TAPA blockOther

    bilateral M-TAPA block with injection of 20 ml of 0.25% bupivacaine.

Study groups in NCT07624058
Study groupRoleWhat they receive
group 1Active comparatorpatients will receive bilateral ESP block
Receives: Other: bilateral ESP block
group 2Experimentalpatients will receive bilateral M-TAPA block
Receives: Other: bilateral M-TAPA block

What is being measured

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

  1. Time to First Analgesic request

    minutes

    Measured: postoperative day 1

Secondary outcomes (4)
  1. Total Nalbuphine consumption

    mg

    Measured: postoperative day 1

  2. Visual analogue score

    0 no pain , 10 severe pain

    Measured: postoperative day1

  3. Quality of postoperative recovery

    QOR 15

    Measured: postoperative day 1

  4. Incidence of complications or adverse events

    local anesthetic toxicity, bleeding

    Measured: postoperative day 5

Timeline

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

  1. First posted3 Jun 2026
  2. Study start1 Apr 2026
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07624058
Sponsor's protocol ID
0109414
Status last verified
May 2026
First submitted
29 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.

    PubMed 30639940

Questions about this trial

What is this clinical trial studying?

A study testing bilateral ESP block and bilateral M-TAPA block in people with Erector Spinae Block and Modified Thoracoabdominal Nerve Block, run by Alexandria University at 1 site in Egypt.

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 3 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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 Egypt. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact sarah m elgamal, MD (01005496440, sarahelgamal1990@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Analgesic request (time frame: postoperative day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07624058, which also lists 1 linked publication.

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 3 Jun 2026.

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