NCT05297981

Brief Summary

Postoperative pain after laparoscopic abdominal surgeries can be severe. Despite multimodal analgesia protocols, administration of high doses of opioids is often required hindering early mobilization and discharge of the patient from the day surgery setting and is suboptimal in an Early Recovery after Surgery setting. Settings and design A prospective randomized double blinded study. Aim To evaluate and compare the analgesic effect of ultrasound-guided erector spinae plane (ESP) block with ultrasound-guided posterior Quadratus Lumborum Block in laparoscopic abdominal surgeries. Patients and methods This randomized prospective study will be carried for 6 months on adult patients with American Society of Anesthesiologists (ASA) Physical Status Class I and II, aged between 30 and 60 years.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2022

Completed
Last Updated

April 12, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

February 16, 2022

Last Update Submit

April 5, 2022

Conditions

Keywords

Laparoscopic surgeriesErector spinae plane blockQuadratus lumborum block

Outcome Measures

Primary Outcomes (1)

  • The first time to rescue analgesia

    The time to ask for postoperative analgesia is the time from the end of operation to patient reporting Visual analogue scale ≥ 5. Pain assessments are conducted by a researcher who is unaware of the grouping

    (recorded within the first 24 hour postoperatively)

Secondary Outcomes (1)

  • Visual analogue scale (VAS)

    measured immediate after surgery, 2,6,12,24 hours postoperatively

Study Arms (2)

Group E

EXPERIMENTAL

Erector spinae plane block

Procedure: Erector spinae plane block

Group Q

EXPERIMENTAL

Quadratus lumborum block

Procedure: Quadratus lumborum block

Interventions

The patient will be placed in lateral decubitus position. A high frequency linear probe of a transportable Fuji M-Turbo ultrasound system will be placed on the spinous process at T8 level on the parasagittal plane and then slide 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle. Using the inplane technique,then 0.5 ml/kg of 0.25% bupivacaine will be injected between the muscle and transverse process. The same procedure will be performed bilaterally.

Group E

The patient will be placed in the lateral decubitus position. A low frequency curved probe of a transportable Fuji M-Turbo ultrasound system will be placed horizontally in the anterior axillary line midway between the subcostal margin and the iliac crest to identify the triple abdominal muscle layers.A 22-G, 80-mm needle echogenic needle will be inserted in plane relative to the US probe, into the posterior aspect of the QL muscle (between QL and erector spinae muscle); this is known as QLB type 2. Then, 0.5 ml/kg of 0.25% bupivacaine will be injected behind the muscle as a bolus dose. The block will be performed bilaterally.

Group Q

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients will be included in the study aged 30-60 years.
  • ASA Physical Status Class I and II.
  • Elective laparoscopic abdominal surgery under general anesthesia.

You may not qualify if:

  • Infection at injection site.
  • History of allergy to local anesthetics.
  • Coagulation disorders.
  • Physical or mental diseases which may interfere with the evaluation of pain scores.
  • Kidney failure or liver cell failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelrahman Mohamed

Cairo, 11311, Egypt

RECRUITING

Related Publications (1)

  • 1. Ljungqvist O, Scott M, Fearon KC. Enhanced recovery after surgery: a review. JAMA Surg.2017;152(3):292-298. 2. Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007; 35:616-7. 3. M. Forero, S. D. Adhikary, H. Lopez, C. Tsui, and K. J. Chin, "The erector spinae plane block a novel analgesic technique in thoracic neuropathic pain," Regional Anesthesia and Pain Medicine, vol. 41, no. 5, pp. 621-627, 2016. 4. K. J. Chin, S. Adhikary, N. Sarwani, and M. Forero, "The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair," Anaesthesia, vol. 72, no. 4, pp. 452-460, 2017 5. Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Børglum J, et al. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015; 32:764- 70 6. El-Boghdadly K, Elsharkawy H, Short A, Chin KJ. Quadratus lumborum block nomenclature and anatomical considerations. Reg Anesth Pain Med.2016;41(4):548-549 7. Ueshima H, Otake H, Jui-An L. Ultrasound-guided quadratus lumborum block: an updated review of anatomy and techniques. Biomed Res Int. 2017; 2017:1-7 8. Aditianingsih D, Pryambodho AN, Tantri AR, et al. A randomized controlled trial on analgesic effect of repeated quadratus lumborum block versus continuous epidural analgesia following laparoscopic nephrectomy. BMC Anesthesiol. 2019; 19:221 9. Niraj G, Tariq Z. Continuous erector spinae plane (ESP) analgesia in different open abdominal surgical procedures: a case series. J Anesth Surg. 2018;5(1):57-60

    BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This randomized prospective study will be carried out in Ain shams university hospitals for 6 months on 82 adult patients with American Society of Anesthesiologists (ASA) Physical Status Class I and II, aged between 30 and 60 years, and scheduled for laparoscopic abdominal surgery after approval by local ethical committee. Written and informed consent will be taken from each patient. Every patient will receive an explanation to the purpose of the study and will have a secret code number to ensure privacy to participant and confidentiality of data. Patients will be randomly allocated into two equal groups: * Group E (41 patients): Each patient will receive general anesthesia plus bilateral ESP block. * Group Q (41 patients): Each patient will receive general anesthesia plus bilateral posterior QLB.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

March 28, 2022

Study Start

November 23, 2021

Primary Completion

May 10, 2022

Study Completion

May 23, 2022

Last Updated

April 12, 2022

Record last verified: 2022-02

Locations