"Analgesic Efficacy of Combined Transversus Abdominis Plane Block and Posterior Rectus Sheath Block in Patients Undergoing Laparoscopic Appendectomy"

ERAS Clinical Trial

Official title:

"Analgesic Efficacy of Combined Transversus Abdominis Plane Block and Posterior Rectus Sheath Block in Patients Undergoing Laparoscopic Appendectomy"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06088082
• Other study ID #: E-21-6173
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 1, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: October 2023
• Source: King Saud Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 20, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• ERAS

Intervention

Drug:
• Bupivacaine Hydrochloride
Patients will be randomly assigned to receive a TAP and PRS blocks with 34 mL of 0.25% bupivacaine (study group) or standard hospital analgesia protocol (control group).

Locations

Country	Name	City	State
Saudi Arabia	Rashid Saeed Khokhar	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud Medical City

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (12)

Alizadeh R, Aghsaie Fard Z. Renal impairment and analgesia: From effectiveness to adverse effects. J Cell Physiol. 2019 Aug;234(10):17205-17211. doi: 10.1002/jcp.28506. Epub 2019 Mar 27. — View Citation

Alizadeh R, Mireskandari SM, Azarshahin M, Darabi ME, Padmehr R, Jafarzadeh A, Aghsaee-Fard Z. Oral clonidine premedication reduces nausea and vomiting in children after appendectomy. Iran J Pediatr. 2012 Sep;22(3):399-403. — View Citation

Beiranvand S, Karimi A, Vahabi S, Amin-Bidokhti A. Comparison of the Mean Minimum Dose of Bolus Oxytocin for Proper Uterine Contraction during Cesarean Section. Curr Clin Pharmacol. 2019;14(3):208-213. doi: 10.2174/1574884714666190524100214. — View Citation

Beiranvand S, Sorori MM. Pain management using nanotechnology approaches. Artif Cells Nanomed Biotechnol. 2019 Dec;47(1):462-468. doi: 10.1080/21691401.2018.1553885. — View Citation

Beverly A, Kaye AD, Ljungqvist O, Urman RD. Essential Elements of Multimodal Analgesia in Enhanced Recovery After Surgery (ERAS) Guidelines. Anesthesiol Clin. 2017 Jun;35(2):e115-e143. doi: 10.1016/j.anclin.2017.01.018. — View Citation

Khoo CK, Vickery CJ, Forsyth N, Vinall NS, Eyre-Brook IA. A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Ann Surg. 2007 Jun;245(6):867-72. doi: 10.1097/01.sla.0000259219.08209.36. — View Citation

Ma N, Duncan JK, Scarfe AJ, Schuhmann S, Cameron AL. Clinical safety and effectiveness of transversus abdominis plane (TAP) block in post-operative analgesia: a systematic review and meta-analysis. J Anesth. 2017 Jun;31(3):432-452. doi: 10.1007/s00540-017-2323-5. Epub 2017 Mar 7. — View Citation

Moradkhani M, Hejri P, Nadri S, Beiranvand S. Effects of ADJUVANT Ketamine on Induction of Anesthesia for the Cesarean Section. Curr Rev Clin Exp Pharmacol. 2021;16(2):197-200. doi: 10.2174/1574884715666200310103317. — View Citation

Muller S, Zalunardo MP, Hubner M, Clavien PA, Demartines N; Zurich Fast Track Study Group. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. 2009 Mar;136(3):842-7. doi: 10.1053/j.gastro.2008.10.030. Epub 2008 Nov 1. — View Citation

Robertson TC, Hall K, Bear S, Thompson KJ, Kuwada T, Gersin KS. Transversus abdominis block utilizing liposomal bupivacaine as a non-opioid analgesic for postoperative pain management. Surg Endosc. 2019 Aug;33(8):2657-2662. doi: 10.1007/s00464-018-6543-z. Epub 2018 Nov 2. — View Citation

Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747. — View Citation

Tupper-Carey DA, Fathil SM, Tan YK, Kan YM, Cheong CY, Siddiqui FJ, Assam PN. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy. Singapore Med J. 2017 Aug;58(8):481-487. doi: 10.11622/smedj.2016068. Epub 2016 Apr 8. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess the pain score by verbal numerical rating scale[VNRS]	to assess the pain score by using verbal numerical rating scale [0-10]in immediate postop period on arrival in PACU and then after 2,4,6,12 and 24 hours postop.between two groups.Low scores on verbal numerical rating scale will be beneficial factor in early discharge of patients from the hospital.	7 months
Secondary	opiod consumption	to measure opiods consumption in milligrams[mg] during intraop followed in PACU and after 4,6,12 and 24 hours postop.	7 months
Secondary	early mobility after surgery measured by john hopkins highest level of mobility scale[JH-HLM]	early mobility after surgery measured by john hopkins highest level of mobility scale[JH-HLM] this scale is a validated 1-item ordinal scale ranging from lying passively in bed[score=1] to walking equal or more than 250 feet [score=8] within immediate postop and within 24 hours postop.high scores on mobility scale used indicates early patient mobility and discharge from the hospital.	7 months
Secondary	to assess the severity of postoperative [PONV] during immediate postop and after 4,6,12 and 24 hours postop.	to assess the severity of postoperative [PONV]; during immediate postop and after 4,6,12 and 24 hours postop. by using numeral rating scale [0-10]for nausea as no for score 0,mild for 1-3,moderate for 4-6, and severe for 7-10 with propensity to vomiting.and document vomiting by yes or no.low scores on verbal numerical rating scale for nausea will be contributing early discharge of the patients from the hospital.	7 months