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

Laparoscopic Appendectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220513
• Other study ID #: laparoscopic appendectomy pain
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: Eman Abdelnaby, master
• Phone: 01094675379
• Email: Eman_soliman[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Laparoscopic Appendectomy

Intervention

Procedure:
• erector spinae plane block (ESP)
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)
patients will receive Ultrasound-guided transversus abdominis plane block(TAP) Block for postoperative analgesia of adult patients undergoing laparoscopic appendectomy.

Locations

Country	Name	City	State
Egypt	Ain shams university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraoperative heart rate	Heart rate (HR)in beat per minute will be recorded every 5 min till the end of the surgery.	the duration of surgery
Secondary	Incidence of complications	Including nerve injury, hematoma formation, Local anesthetic toxicity, and intravascular injections;	the duration of surgery
Secondary	the cumulative consumption of pethidine	At a NRS pain scores of four or above, 50 mg of intravenous pethidine was administered. The total dose of analgesics administered during the first 24 hours will be carefully recorded.	the first 24 postoperatively
Secondary	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.	first postoperative hour
Secondary	intraoperative blood pressure monitoring	mean arterial pressure (MAP) in millimeter mercury will be recorded every 5 min till the end of the surgery.	the duration of surgery