AzTrials
AzTrials

Laparoscopic AppendectomyNCT06220513

Erector Spinae Plane Block Versus TAP Block for Postoperative Analgesia of Laparoscopic Appendectomy

A study testing erector spinae plane block (ESP) and transversus abdominis plane block(TAP) in people with Laparoscopic Appendectomy, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Laparoscopic appendectomy is the most frequently performed surgery in patients who develop acute appendicitis. This surgical technique is more advantageous than an open appendectomy in terms of fewer complications, less postoperative pain, and a faster return to normal daily activities. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Laparoscopic Appendectomy
What is being tested?
erector spinae plane block (ESP) and transversus abdominis plane block(TAP)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteEgypt
Study dates
29 Jan 2024to 8 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients scheduled for laparoscopic appendectomy,
  • Patients aged 18-50 years,
  • American Society of Anaesthesiologists (ASA) physical status I or II.

Who cannot join

  • Declined informed consent.
  • Allergy to local anesthetics.
  • Conversion of the laparoscopic surgery to open appendectomy.
  • Coagulation disorder.
  • Pregnancy,
  • BMI more than 40 kg/m2,
Show all 10Show fewer
  • Respiratory disease, liver or kidney disease; and heart disease (heart block, Rheumatic heart or myocardial ischemia).
  • Psychiatric problems, that results in lack of communication ability.
  • Chronic alcoholism, drug abuse,
  • Infection in the area where the block will be applied.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain shams university hospitals

    Cairo

Other trials in Egypt

About this study

Official title: Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Laparoscopic Appendectomy

Laparoscopic appendectomy is the most frequently performed surgery in patients who develop acute appendicitis. This surgical technique is more advantageous than an open appendectomy in terms of fewer complications, less postoperative pain, and a faster return to normal daily activities. Even though the laparoscopic technique is minimally invasive, postoperative pain is inevitable. Furthermore, it may affect the patients' mobility and cause them to stay in the hospital for a more extended period .The study aimed to compare the effectiveness and the safety of ultrasound-guided erector spinae plane block versus ultrasound-guided transversus abdominis plane block (TAP) as postoperative analgesia methods after laparoscopic appendectomy.

Read the detailed description

Acute appendicitis develops in a progressive and irreversible manner, even if the clinical course of acute appendicitis can be temporarily modified by intentional medications. Reliable and real-time diagnosis of acute appendicitis can be made based on findings of the white blood cell count and enhanced computed tomography. Emergent laparoscopic appendectomy is considered as the first therapeutic choice for Acute appendicitis .

The reported advantages of laparoscopic appendectomy compared with open appendectomy are less postoperative pain, less wound infection, and better cosmetic results. Even though the laparoscopic technique is minimally invasive, postoperative pain is inevitable. Furthermore, it may affect the patients' mobility and cause them to stay in the hospital for a more extended period .An intraperitoneal injection of local anesthetics is one of the analgesic modalities that are used to control pain in such cases but it is insufficient analgesic in most of patients and has short duration effect .

Recently Ultrasound-guided nerve blocks were effectively used for postoperative analgesia in different types of surgical procedures .Both erector spinae plane block and oblique subcostal transversus abdominis plane block have been used effectively to reduce pain after laparoscopic appendectomy.

In ultrasound-guided Transversus Abdominis Plane (TAP) Block local anesthetic (LA) is deposited in the plane between the transversus abdominis and posterior sheath of the rectus muscle in approximately midway between the iliac crest and costal margin .To anesthetize The terminal branches of the lower six thoracic and first lumbar nerve lie within, providing analgesia of the anterior and lateral abdominal wall .This block has a low risk for serious complications such as bowel or diaphragm perforation and lacerations of the liver. Abdominal wall hematoma, vascular injury, and local anesthetic toxicity are also potential but rare complications . Owing to safety of ultrasound-guided needle placement a 'real-time' visualization through dynamic scanning is used .

The ultrasound-guided Erector Spinae Plane (ESP) block is a paraspinal fascial plane block in which local anesthetic is administered between the erector spinae muscle and the thoracic transverse processes at the levels of the T7-T9 transverse processes, resulting in spread between the T6 and T12 segmental levels, blocking the dorsal and ventral rami of the abdominal spinal nerves.

This blockage of the dorsal and ventral rami of the spinal nerves helps to achieve a multi-dermatomal sensory block of the anterior, posterior, and lateral abdominal walls.

ESP block Complications such as vascular puncture, pleural puncture and pneumothorax are the primary complications .Also local anethetic toxicity, infection at needle insertion site and allergy also can occur .

Being tested
erector spinae plane block (ESP), transversus abdominis plane block(TAP)
Keywords
transversus abdominis plane block, erector spinae plane block

What participants receive

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

  • erector spinae plane block (ESP)Procedure or surgery

    patients will receive Ultrasound-guided erector spinae plane block (ESP) block for postoperative analgesia of adult patients undergoing laparoscopic appendectomy.

  • transversus abdominis plane block(TAP)Procedure or surgery

    patients will receive Ultrasound-guided transversus abdominis plane block(TAP) Block for postoperative analgesia of adult patients undergoing laparoscopic appendectomy.

Study groups in NCT06220513
Study groupRoleWhat they receive
Group A (ESP) block groupActive comparatorthe first group (ESP) will be placed in the lateral decubitus position. The ultrasound probe will be placed in longitudinal orientation at the level of the T9spinous process and then moved the probe 3 cm laterally from the midline. The ultrasound landmarks, which included the T9 transverse process and the overlying erector spinae muscle, will be identified. Under complete aseptic conditions, an 80-mm 21-gauge block needle will be inserted in plane at an angle of 30-40° in cranial-to-caudal direction until the tip contacted the T9 transverse process. After hydro-dissection with 3 mL of isotonic saline solution confirmed the correct needle tip position, 20mL of 0.25% bupivacaine will be injected deep to the erector spinae muscle. The same procedure will be repeated with 20mL of 0.25% bupivacaine solution on the contralateral side.
Receives: Procedure: erector spinae plane block (ESP)
Group B TAP block groupActive comparatorpatients who will receive TAP block. A high-frequency ultrasound probe placed transversely, approximately midway between the iliac crest and costal margin shows the three muscle layers of the abdominal wall. A regional block needle can then be inserted anteriorly and slightly away from the probe and carefully advanced until it reaches the transversus plane. In this 'in-plane' technique. The needle and its tip are visualised throughout the procedure, as it enters the transversus plane after piercing the fascial layer below the internal oblique muscle. The needle will be directed toward the transversus abdominis fascia and injected 20 mL of 0.25% bupivacaine between the rectus abdominis and transversus abdominis muscles. The same procedure will be repeated with 20mL of 0.25% bupivacaine solution on the contralateral side.
Receives: Procedure: transversus abdominis plane block(TAP)

What is being measured

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

  1. a numerical rating scale (NRS)

    an 11-point scale where 0 indicates no pain and 10 indicates the worst imaginable pain. Patients will chose a whole number to express the degree of their pain both at rest and when moving.

    Measured: Patients will be asked to record their level of pain at 30 minutes as well as at two, four, six, eight, 12, 18 and 24 hours postoperatively.

Secondary outcomes (5)
  1. Intraoperative heart rate

    Heart rate (HR)in beat per minute will be recorded every 5 min till the end of the surgery.

    Measured: the duration of surgery

  2. Incidence of complications

    Including nerve injury, hematoma formation, Local anesthetic toxicity, and intravascular injections;

    Measured: the duration of surgery

  3. the cumulative consumption of pethidine

    At a NRS pain scores of five or above, 50 mg of intravenous pethidine was administered. The total dose of analgesics administered during the first 24 hours will be carefully recorded.

    Measured: the first 24 postoperatively

  4. The duration of time before the first request for rescue analgesia post-surgically.

    The maximum allowed dose of pethidine will be set at 5 mg/kg/24 h based on lean body weight. The blocks will be considered as failed blocks if patients require more than two doses of rescue analgesia in the first postoperative hour.

    Measured: first postoperative hour

  5. intraoperative blood pressure monitoring

    mean arterial pressure (MAP) in millimeter mercury will be recorded every 5 min till the end of the surgery.

    Measured: the duration of surgery

Timeline

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

  1. First posted24 Jan 2024
  2. Study start29 Jan 2024
  3. Primary completion8 Jul 2025
  4. Study completion8 Jul 2025

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
Model description
: a double -blinded randomized clinical study.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06220513
Sponsor's protocol ID
laparoscopic appendectomy pain
Status last verified
Jul 2025
First submitted
6 Jan 2024
Last updated
3 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Altiparmak B, Korkmaz Toker M, Uysal AI, Kuscu Y, Gumus Demirbilek S. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial. J Clin Anesth. 2019 Nov;57:31-36. doi: 10.1016/j.jclinane.2019.03.012. Epub 2019 Mar 6.

    PubMed 30851501
  • Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.

    PubMed 19020158
  • De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.

    PubMed 30621377
  • Sertcakacilar G, Yildiz GO. Analgesic efficacy of ultrasound-guided transversus abdominis plane block and lateral approach quadratus lumborum block after laparoscopic appendectomy: A randomized controlled trial. Ann Med Surg (Lond). 2022 Jun 14;79:104002. doi: 10.1016/j.amsu.2022.104002. eCollection 2022 Jul.

    PubMed 35860161
  • Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

    PubMed 29913392
  • Yu N, Long X, Lujan-Hernandez JR, Succar J, Xin X, Wang X. Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15;14:121. doi: 10.1186/1471-2253-14-121. eCollection 2014.

    PubMed 25580086
  • Mohamed Soliman EA, Abdelgani Basyoni M, Hafni Soliman AF, Abdelmawla Saleh M, Attia Sami ES. Ultrasound-Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Adult Patients Undergoing Laparoscopic Appendectomy. Anesthesiol Res Pract. 2026 May 22;2026:6654154. doi: 10.1155/anrp/6654154. eCollection 2026.

    PubMed 42180591

Questions about this trial

What is this clinical trial studying?

A study testing erector spinae plane block (ESP) and transversus abdominis plane block(TAP) in people with Laparoscopic Appendectomy, run by Ain Shams 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 10 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: finished, as of the sponsor's last update on 3 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a numerical rating scale (NRS) (time frame: Patients will be asked to record their level of pain at 30 minutes as well as at two, four, six, eight, 12, 18 and 24 hours postoperatively.). 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 NCT06220513, which also lists 7 linked publications.

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 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in