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AnesthesiaNCT07280949

Posterior Transversus Abdominis Plane Block Combined With Sacral Multifidus Plane Block Versus Posterior Transversus Abdominis Plane Block for Laparoscopic Colorectal Surgery

A study testing sacral multifidus plane block and TAP Block: posterior approach in people with Anesthesia and Posterior Transversus Abdominis Plane Block, run by Cairo 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

The aim of this study is to compare perioperative analgesic efficacy and safety profile of combined SMPB and posterior TAP block versus posterior TAP block in patients undergoing laparoscopic colorectal cancer surgery. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
What is being tested?
sacral multifidus plane block and TAP Block: posterior approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
Jan 2026to Jun 2026
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 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 90 years
  • Male or female
  • ASA class I to III
  • Elective laparoscopic or robotic colorectal surgery with or without resections requiring perineal incisions.

Who cannot join

  • Patient refusal
  • History of previous abdominal surgery, preoperative bowel obstruction symptoms, and requirement for emergency surgery
  • Conversion to open laparotomy
  • Coagulopathy, infection at the injection site, allergy to local anesthetics, body mass index > 30 kg/m2, severe hepatic or renal disease, severe cardiopulmonary disease (≥ ASA IV), diabetic or other neuropathies, patients receiving opioids for chronic analgesic therapy, inability to comprehend visual analogue scale (VAS) and patients transferred to the intensive care unit (ICU) post-surgery.

Trial locations and contacts

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

Egypt1 site, 1 recruiting
  • Cairo University

    Cairo, Governorate, 002

    Nagy malak, 01552480258, nagymalak12345@gmail.com

    Mahmoud Reda Sewilam, MD

    Recruiting

Other trials in Egypt

About this study

Official title: Comparison of Posterior Transversus Abdominis Plane Block Combined With Sacral Multifidus Plane Block Versus Posterior Transversus Abdominis Plane Block for Laparoscopic Colorectal Surgery: A Randomized Controlled Trial

The aim of this study is to compare perioperative analgesic efficacy and safety profile of combined SMPB and posterior TAP block versus posterior TAP block in patients undergoing laparoscopic colorectal cancer surgery.

Read the detailed description

On arrival of the patients to operating room, patients will be secured with 20 gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure (NIBP), and pulse oximeter (SpO2). Before receiving general anesthesia, patients will be randomly assigned into one of the two study groups; SMPB with TAP block Group and TAP block Group.

Induction of general anesthesia will be induced with patients after adequate preoxygenation using 1 µg/kg fentanyl (based on lean body weight), 2 mg/kg of propofol (based on total body weight) and 0.5 mg/kg of atracurium (based on the ideal body weight), in addition to 8mg IV dexamethasone for prevention of postoperative nausea \& vomiting. Endotracheal intubation will be established. Anesthesia will be maintained by 1.2% MAC of isoflurane with oxygen (50%) in air and 0.1 mg/kg of atracuri¬um will be administered every 20 minutes as main¬tenance anesthetic drugs. Volume-controlled ventilation will be maintained with a tidal volume of 6 mL/kg of ideal body weight and the respiratory rate will be adapted to maintain ET CO2 between 30 and 40 mmHg. Moni¬toring through ECG, NIBP, pulse oximeter and capnograph (ETCO2) continued throughout the surgeries.

US (Siemens ACUSON X300 Ultrasound System) guided blocks will be administered immediately after the induction of anesthesia and prior to surgical incision by consultant anesthesiologist who had experience in regional anesthesia and were familiar with the SMPB \& TAP blocks. To achieve double blinding, patients will receive the block by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients intraoperative and postoperative.

SMPB \& TAP Block Group (ST-Group): this group will receive bilateral ultrasound-guided SMPB \& TAP block TAP block Group (T-Group): this group will receive bilateral ultrasound-guided TAP block Technique of SMPB block: sacral foramen injection technique The patient in lateral position. A curvilinear ultrasound probe (5-7 MHz) will be placed longitudinally in the midline just above the median sacral crest. After identifying the hyper echoic median sacral crest with the overlying hypo echoic latissimus dorsi muscle, the probe will be moved laterally to identify the intermediate crest, the dorsal sacral foramina (DSF), longissimus thoracic muscle, and multifidus muscle (MFM). After optimizing the image at the S2 level, a 21G 80 mm block needle will be advanced in an in plane approach until the needle reached the sacral foramen. A distinct loss of resistance will be felt once the needle pierced the fibrous covering of S2 foramen. After negative aspiration, a total of 20 mL bupivacaine 0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side(15) Technique of TAP Block: posterior approach The patient in semi-lateral position. A linear ultrasound probe (4-12MHz) will be placed posterior to the mid-axillary line between the costal margin and the iliac crest. When scanning posteriorly, transversus abdominis tailed off and turned into aponeurosis. Subsequently, a blunt-ended needle will be introduced into the TAP between the internal oblique and transversus abdominis, posterior to the mid-axillary line and near the aponeurosis. After confirmation with saline solution into the facial plane, as the appearance of a hypo echoic ellipsoid with well-defined margins on ultrasound imaging. After negative aspiration, a total of 20 mL bupivacaine0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side(16).

The surgery can begin after 15 minutes from block time which is the usual time for sterilization.

Intraoperative inadequate analgesia, indicated by increase of heart rate (HR) or mean arterial blood pressure (MAP) more than 20% above preinduction baseline values, will be managed using incremental 50 microgram doses of fentanyl with a maximum total dose of 5 mcg/kg if additional doses are required. Intraoperative fentanyl consumption will be calculated. All patients will receive 10 minutes before the end of surgery 1 mg granisetron or 4 mg ondansetron IV for antiemetic prophylaxis and ketorolac 30mg IV and paracetamol 1g for postoperative analgesia. At the end of surgery, muscle relaxant will be reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Awake Extubation will be established after adequate reversal of neuromuscular block.

Patients will be transported to post-anesthesia care unit (PACU). In the PACU, patients will be placed in the semi-sitting position, and oxygen will be given via a nonrebreathing facemask with a reservoir bag. Postoperative pain will be assessed using VAS (where 0 corresponds to no pain and 100 mm to the worst pain) at 2, 4, 6, 12, 18, 24 hours postoperatively and on hospital discharge Postoperatively, in the ward, all patients will receive regular analgesia 1 g paracetamol every 6 h, 30 mg ketorolac every 6 h, 1 mg granisetron or 4 mg ondansetron IV for postoperative nausea and vomiting and diphenhydramine 25-50 mg IV for the treatment of pruritus as needed. Intravenous rescue morphine 2 mg if needed will be carried out at patient wake-up to achieve pain control (VAS ≤ 30mm) by an attending anesthesiologist blinded to group allocation. Patients with a VAS score of ≥ 40mm and patients who will request rescue analgesia will be treated with IV morphine in 2 mg increments every 5 minutes with no upper limit for the total administered dose and total morphine consumption will be recorded. If the patient appeared sedated (Ramsay sedation scale > 2), and/or severe morphine-related side effects are encountered including respiratory depression (Spo2 < 95% and/or respiratory rate < 12 breaths/min), allergic reaction, hypotension, or severe pruritus, morphine titration will be stopped and the patient will be excluded from the study.

Being tested
sacral multifidus plane block, TAP Block: posterior approach
Keywords
transversus abdominis plane block, Sacral block, Laparoscopic, Colorectal surgeries

What participants receive

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

  • sacral multifidus plane blockProcedure or surgery

    The patient in lateral position. A curvilinear ultrasound probe (5-7 MHz) will be placed longitudinally in the midline just above the median sacral crest. After identifying the hyper echoic median sacral crest with the overlying hypo echoic latissimus dorsi muscle, the probe will be moved laterally to identify the intermediate crest, the dorsal sacral foramina (DSF), longissimus thoracic muscle, and multifidus muscle (MFM). After optimizing the image at the S2 level, a 21G 80 mm block needle will be advanced in an in plane approach until the needle reached the sacral foramen. A distinct loss of resistance will be felt once the needle pierced the fibrous covering of S2 foramen. After negative aspiration, a total of 20 mL bupivacaine 0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side

  • TAP Block: posterior approachProcedure or surgery

    The patient in semi-lateral position. A linear ultrasound probe (4-12MHz) will be placed posterior to the mid-axillary line between the costal margin and the iliac crest. When scanning posteriorly, transversus abdominis tailed off and turned into aponeurosis. Subsequently, a blunt-ended needle will be introduced into the TAP between the internal oblique and transversus abdominis, posterior to the mid-axillary line and near the aponeurosis. After confirmation with saline solution into the facial plane, as the appearance of a hypo echoic ellipsoid with well-defined margins on ultrasound imaging. After negative aspiration, a total of 20 mL bupivacaine0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side.

Study groups in NCT07280949
Study groupRoleWhat they receive
SMPB & TAP Block Group (ST-Group): bilateral ultrasound-guided SMPB & TAP blockActive comparatorPatient in lateral position. A curvilinear ultrasound probe (5-7 MHz) will be placed longitudinally in midline just above median sacral crest. After identifying hyper echoic median sacral crest with overlying hypo echoic latissimus dorsi muscle, the probe will be moved laterally to identify intermediate crest, dorsal sacral foramina (DSF), longissimus thoracic muscle, and multifidus muscle (MFM). After optimizing the image at S2 level, 21G 80 mm block needle will be advanced in plane approach until needle reached sacral foramen. A distinct loss of resistance will be felt once the needle pierced the fibrous covering of S2 foramen. After negative aspiration, a total of 20 mL bupivacaine 0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side.
Receives: Procedure: sacral multifidus plane block; Procedure: TAP Block: posterior approach
TAP block Group (T-Group): this group will receive bilateral ultrasound-guided TAP blockExperimentalTechnique of TAP Block: posterior approach The patient in semi-lateral position. A linear ultrasound probe (4-12MHz) will be placed posterior to the mid-axillary line between the costal margin and the iliac crest. When scanning posteriorly, transversus abdominis tailed off and turned into aponeurosis. Subsequently, a blunt-ended needle will be introduced into the TAP between the internal oblique and transversus abdominis, posterior to the mid-axillary line and near the aponeurosis. After confirmation with saline solution into the facial plane, as the appearance of a hypo echoic ellipsoid with well-defined margins on ultrasound imaging. After negative aspiration, a total of 20 mL bupivacaine0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side.
Receives: Procedure: TAP Block: posterior approach

What is being measured

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

  1. Visual analogue pain score (VAS)

    (VAS) at rest and during coughing at 2hr postoperative.

    Measured: 2 hours

Secondary outcomes (8)
  1. Fentanyl consumption

    Intraoperative fentanyl consumption

    Measured: 6 hours

  2. Time to first postoperative analgesic request

    Time to first postoperative analgesic request

    Measured: 24 hours

  3. Total morphine requirements

    Total morphine requirements 24 hours postoperatively

    Measured: 24 hours

  4. Visual analogue pain score (VAS)

    1. Visual analogue pain score (VAS) at rest and during coughing at 4, 6, 12, 18 and 24 hours postoperatively

    Measured: 24 hours

  5. Quality of Recovery (QoR-15) scale

    Quality of Recovery (QoR-15) scale at 24 hours after surgery.

    Measured: 24 hours

  6. Incidence of complications

    Incidence of complications related to the blocks.(infection, hematoma ,bleeding, nerve injury, local anesthetic toxicity, intravascular injection)

    Measured: 24 hours

  7. Incidence of postoperative nausea and vomiting

    Incidence of postoperative nausea and vomiting (Nausea was recorded on a graded scale, with 0 indicating no symptom, 1 indicating symptoms, 2 indicating symptoms requiring treatment, and 3 indicating a vomiting event

    Measured: 24 hours

  8. Time to first flatus & development of postoperative ileus

    Time to first flatus \& development of postoperative ileus

    Measured: 24 hours

Timeline

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

  1. First posted15 Dec 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07280949
Sponsor's protocol ID
MD-318-2025
Status last verified
Dec 2025
First submitted
1 Dec 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing sacral multifidus plane block and TAP Block: posterior approach in people with Anesthesia and Posterior Transversus Abdominis Plane Block, run by Cairo 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 4 inclusion and 4 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 15 Dec 2025. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue pain score (VAS) (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Dec 2025.

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