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

October 14, 2023 updated by: Rashid Saeed Khokhar, King Saud Medical City
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL GROUP
) will receive standard routine postoperative analgesia at our institute.
Experimental: TREATMENT GROUP
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
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).
Other Names:
  • TRASVERSE ABDOMINIS AND POSTERIOR RECTUS SHEATH BLOCKS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess the pain score by verbal numerical rating scale[VNRS]
Time Frame: 7 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
opiod consumption
Time Frame: 7 months
to measure opiods consumption in milligrams[mg] during intraop followed in PACU and after 4,6,12 and 24 hours postop.
7 months
early mobility after surgery measured by john hopkins highest level of mobility scale[JH-HLM]
Time Frame: 7 months
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
to assess the severity of postoperative [PONV] during immediate postop and after 4,6,12 and 24 hours postop.
Time Frame: 7 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud Medical City

Investigators

  • Principal Investigator: rashid khokhar, fcps, King Saud Medical City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 20, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

October 14, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-21-6173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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