NCT06220513

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

January 29, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2025

Completed
Last Updated

February 3, 2026

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

January 6, 2024

Last Update Submit

January 31, 2026

Conditions

Keywords

transversus abdominis plane blockerector spinae plane block

Outcome Measures

Primary Outcomes (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.

    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)

  • Intraoperative heart rate

    the duration of surgery

  • Incidence of complications

    the duration of surgery

  • the cumulative consumption of pethidine

    the first 24 postoperatively

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

    first postoperative hour

  • intraoperative blood pressure monitoring

    the duration of surgery

Study Arms (2)

Group A (ESP) block group

ACTIVE COMPARATOR

the 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.

Procedure: erector spinae plane block (ESP)

Group B TAP block group

ACTIVE COMPARATOR

patients 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.

Procedure: transversus abdominis plane block(TAP)

Interventions

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

Group A (ESP) block group

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

Group B TAP block group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Declined informed consent.
  • Allergy to local anesthetics.
  • Conversion of the laparoscopic surgery to open appendectomy.
  • Coagulation disorder.
  • Pregnancy,
  • BMI more than 40 kg/m2,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university hospitals

Cairo, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 30851501BACKGROUND
  • 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.

    PMID: 19020158BACKGROUND
  • 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.

    PMID: 30621377BACKGROUND
  • 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.

    PMID: 35860161BACKGROUND
  • 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.

    PMID: 29913392BACKGROUND
  • 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.

    PMID: 25580086BACKGROUND

Study Officials

  • Amira Fathy, MD

    Ainshams university

    STUDY DIRECTOR
  • Mohsen Basyoni, MD

    Ainshams university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
\- Patients will be allocated in two groups using computer-generated table by a person who has access to the computer-generated table but is not involved in data collection or patient management perioperatively. BLock will be given by Anesthesiologist who is not involved in the study.Data collection will be carried out by a person who is completely blinded to the randomization. The person who analyzed the data statistically will not be involved in randomization or data collection.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: : a double -blinded randomized clinical study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer ofAnaesthesia, intensive care and pain management, Ain Shams university

Study Record Dates

First Submitted

January 6, 2024

First Posted

January 24, 2024

Study Start

January 29, 2024

Primary Completion

July 8, 2025

Study Completion

July 8, 2025

Last Updated

February 3, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations