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ERASPhase 3NCT06088082

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

A Phase 3 study testing Bupivacaine Hydrochloride in people with ERAS, run by King Saud Medical City at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 60 yearsHealthy volunteers can take part
Conditions the study is for
ERAS
What is being tested?
Bupivacaine Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSaudi Arabia
Study dates
1 Oct 2023to 20 Apr 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Rashid Saeed Khokhar

    Riyadh

Other trials in Saudi Arabia

About this study

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.

Read the 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.

Conditions
ERAS
Being tested
Bupivacaine Hydrochloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine HydrochlorideDrug

    Also called TRASVERSE ABDOMINIS AND POSTERIOR RECTUS SHEATH BLOCKS

    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).

Study groups in NCT06088082
Study groupRoleWhat they receive
CONTROL GROUPNo intervention) will receive standard routine postoperative analgesia at our institute.
TREATMENT GROUPExperimentalThe 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 .
Receives: Drug: Bupivacaine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 months

Secondary outcomes (3)

  1. opiod consumption

    to measure opiods consumption in milligrams[mg] during intraop followed in PACU and after 4,6,12 and 24 hours postop.

    Measured: 7 months

  2. 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.

    Measured: 7 months

  3. 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.

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2023
  2. Study start1 Oct 2023
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion20 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06088082
Sponsor's protocol ID
E-21-6173
Status last verified
Oct 2023
First submitted
16 May 2023
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30390161

  • 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.

    PubMed 32156239

  • 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.

    PubMed 30916404

  • 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.

    PubMed 31124424

  • 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.

    PubMed 28271227

  • 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.

    PubMed 30688094

  • 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.

    PubMed 27056207

  • 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.

    PubMed 23400517

  • 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.

    PubMed 17522511

  • 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.

    PubMed 19135997

  • 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.

    PubMed 28059913

  • 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.

    PubMed 28526156

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bupivacaine Hydrochloride in people with ERAS, run by King Saud Medical City at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to assess the pain score by verbal numerical rating scale[VNRS] (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06088082, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.

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