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

NCT06088082 | Unknown Phase 3

• 1 other identifier: E-21-6173
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

ERAS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• opiod consumption

  7 months

• early mobility after surgery measured by john hopkins highest level of mobility scale[JH-HLM]

  7 months

• to assess the severity of postoperative [PONV] during immediate postop and after 4,6,12 and 24 hours postop.

  7 months

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

) will receive standard routine postoperative analgesia at our institute.

TREATMENT GROUP

EXPERIMENTAL

The patients will be divided into two groups; group-1 (n= 50) will receive pre-procedure right US-guided TAP and bilateral PRS blocks with bupivacaine 0.25% 20 ml for TAP block and 10 ml for PRS block .

Drug: Bupivacaine Hydrochloride

Interventions

Bupivacaine Hydrochloride DRUG

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).

Also known as: TRASVERSE ABDOMINIS AND POSTERIOR RECTUS SHEATH BLOCKS

TREATMENT GROUP

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud Medical City: lead

Study Sites (1)

Rashid Saeed Khokhar

Riyadh, Saudi Arabia

Location

Related Publications (12)

• 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.

  PMID: 30390161 BACKGROUND

• 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.

  PMID: 32156239 BACKGROUND

• 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.

  PMID: 30916404 BACKGROUND

• 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.

  PMID: 31124424 BACKGROUND

• 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.

  PMID: 28271227 BACKGROUND

• 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.

  PMID: 30688094 BACKGROUND

• 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.

  PMID: 27056207 BACKGROUND

• 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.

  PMID: 23400517 BACKGROUND

• 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.

  PMID: 17522511 BACKGROUND

• 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.

  PMID: 19135997 BACKGROUND

• 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.

  PMID: 28059913 BACKGROUND

• 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.

  PMID: 28526156 BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• rashid khokhar, fcps

  King Saud Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: . 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant anesthetist

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: October 18, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 20, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

SA (1)