Clinical trial NCT06088082: "Analgesic Efficacy of Combined Transversus Abdominis Plane Block and Posterior Rectus Sheath Block in Patients Undergoing Laparoscopic Appendectomy"
Official title: "Analgesic Efficacy of Combined Transversus Abdominis Plane Block and Posterior Rectus Sheath Block in Patients Undergoing Laparoscopic Appendectomy"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: ERAS
Lead sponsor: King Saud Medical City
Sponsor class: OTHER_GOV
First posted: 2023-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To evaluate the combined efficacy US-guided TAP block and PRS block in patients undergoing laparoscopic appendectomy.

Early mobilization, opioid consumption, Postoperative Nausea \& Vomiting (PONV), length of hospital stay (LOS), patient satisfaction in patients scheduled for laparoscopic appendectomy.
Primary purpose: PREVENTION

Brief summary: laparoscopic appendectomy is most common surgical procedure necessitates evidence-based clinical pathways such as Enhanced Recovery After Surgery (ERAS). The paradigm of surgery has been shifted from open to laparoscopic. Laparoscopic appendectomy is the most common procedure performed in our institute for acute and chronic appendicitis. Pain control in ERAS is one of the key factors for improved outcomes. Surgery induced acute postoperative pain, stress response, and fatigue lead to prolonged convalescence and hospital stay. Optimal titrated safe postoperative pain management in laparoscopic appendectomy patients remains a challenge.

Detailed description: Objectives: To evaluate the efficacy of combined transversus abdominis plane (TAP) and posterior rectus sheath (PRS) blocks on perioperative pain, early mobilization, opioid consumption, Postoperative Nausea \& Vomiting (PONV), length of hospital stay (LOS), patient satisfaction in patients scheduled for laparoscopic appendectomy Methods: 100 patients scheduled for Laparoscopic appendectomy will be recruited in this prospective randomized, blinded clinical study. The patients will be divided into two groups; group-1 (TAP and PRS blocks) (n= 50) will receive intraoperative combined TAP and PRS blocks with bupivacaine 0.25% 2-3 mg/kg, and Group 2 (standard care) (n= 50) will receive standard analgesic protocol in our institute. Intraoperatively, all patients will receive conventional intravenous (IV) analgesics and antiemetics (Paracetamol 1 gram + Lornoxicam 8 mg + Dexamethasone 8mg + Ondansetron 4mg). For breakthrough pain in Post Anesthesia Care Unit (PACU) and ward, all patients will be prescribed for IV PRN (as needed) morphine 2 mg maximum 10 mg, paracetamol 1 gram every 6 hours, lornoxicam 8 mg every 8 hours. During pre-anesthesia assessment patients will be instructed how to use 10 cm numerical rating scale (NRS) (0 cm no pain, 10 cm worse pain) to report pain postoperatively. On arrival to the operation room (OR), all eligible participants will have intravenous (IV) cannula in situ and monitors, according to the Association of Anesthetists of Great Britain and Ireland (AAGBI). Anesthesia will be induced with the following drugs: fentanyl 2mcg/kg, propofol 2mg/kg, followed by rocuronium 1mg/kg to facilitate tracheal intubation. Anesthesia drugs doses will be calculated according to ideal body weight (IBW) and adjusted body weight (AjBW) using this link: https://globalrph.com/medcalcs/adjusted-body-weight-ajbw-and-ideal-body-weight-ibw-calc/. General anesthesia will be maintained with Desflurane Minimum Alveolar Concentration (MAC) value of 0.7-1with Fraction of Inspired Oxygen (FIO2) 45%. Before skin incision, US guide left TAP and bilateral PRS blocks will be performed by the anesthesia consultant/senior registrar. and then at the end of surgical procedure desflurane will be discontinued and 2.5 mg of neostigmine with 0.4 micrograms of glycopyrolate will be given. All patients will be transferred to PACU after tracheal extubation. Patients will be monitored in PACU for hemodynamics, pain measured by NRS, morphine or any other analgesic consumption and for PONV antiemetics will be given as required. And in the ward 2, 6,12 and 24 hourly till discharged to home. Patients will be transferred to the ward from PACU when they achieve modified Aldrete score of 9 on two sequential measurements of 10 minutes' interval. All patients, care providers in PACU \& ward (nurses), and outcome assessors (assistant anesthesiologist) will be blinded to the group allocation. Only the assigned anesthesiologist responsible for perioperative care will be aware of the group allocation to treat any unwanted side effects during and after the operation. And in the ward 2, 6,12 and 24 hourly pain score (NRS) will be assessed till discharged to home.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist \[ASA\] I-III patients
* Age 14-60 years
* Either gender
* Patients scheduled for laparoscopic appendectomy.
* Patient weight 50kg and above.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status IV
* Patients with uncontrolled hypertension.
* Anticipated difficult intubation.
* Allergic to morphine
* Allergic to bupivacaine
* Clinically significant neurological, cardiovascular, renal hepatic disease planned for postoperative surgical intensive care (SICU) admission.
* History of drug abuse or chronic opioid use
* Laparoscopic procedure converted to open.
* The patient weighed 100 kg and above.
* Difficult anatomic landmarks on ultrasound scanning.

Primary outcomes:
measure: to assess the pain score by verbal numerical rating scale[VNRS]
timeFrame: 7 months
Secondary outcomes:
measure: opiod consumption
timeFrame: 7 months
measure: early mobility after surgery measured by john hopkins highest level of mobility scale[JH-HLM]
timeFrame: 7 months
measure: to assess the severity of postoperative [PONV] during immediate postop and after 4,6,12 and 24 hours postop.
timeFrame: 7 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Rashid Saeed Khokhar
Study officials:
affiliation: King Saud Medical City
name: rashid khokhar, fcps
role: PRINCIPAL_INVESTIGATOR
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