NCT05094193

Brief Summary

For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using opioids. The transversus abdominis plane (TAP) block has been used as part of a multimodal analgesia strategy. Besides, Wang et al found that TAP block is more effective than a conventional pain control, but not significatively different from another local incisional pain control that is port site infiltration.So, the aim of this study, is to compare the analgesic efficacy and safety of trocar-site infiltration with ropivacaine with ultrasound-guided TAP block following laparoscopic cholecystectomy when used as part of multimodal analgesia.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

October 1, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

October 3, 2021

Last Update Submit

October 13, 2021

Conditions

Laparoscopic Cholecystectomy

Keywords

Acute pain managementRopivacaineTrocar-site infiltrationTAP-blockLaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (2)

  • Acute postoperative pain

    Visual analog scale (VAS) 0: "no pain" to 10: "severe pain" at rest and cough

    up to 24 hours

  • Total opioid consumption

    Day 1

Secondary Outcomes (5)

  • Length of hospital stay

    up to 1 week

  • postoperative nausea and vomiting

    Day 1

  • Patient satisfaction and quality of recovery

    Day 1

  • Incidence of shoulder pain

    Day 1

  • Postoperative complication

    up to 1 week

Study Arms (2)

Trocar-site infiltration

EXPERIMENTAL

Trocar-site infiltration with 20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 5 mm trocar site) associated with bilateral TAP block with 20 mL of normal saline in each side

Procedure: Trocar-site infiltrationProcedure: TAP block placebo

TAP block

ACTIVE COMPARATOR

Trocar-site infiltration with 20 mL of normal saline associated with bilateral TAP block with 20 mL of ropivacaine 0.375% in each side

Procedure: TAP blockProcedure: Trocar site infiltration placebo

Interventions

Trocar-site infiltrationPROCEDURE

20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site)

Trocar-site infiltration
TAP blockPROCEDURE

bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side

TAP block
Trocar site infiltration placeboPROCEDURE

20 mL of normal saline

TAP block
TAP block placeboPROCEDURE

bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side

Trocar-site infiltration

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \< 30 kg/m2
  • Scheduled for laparoscopic cholecystectomy
  • ASA grade I, II and III

You may not qualify if:

  • Bile duct exploration, insertion of a T-drain or patients with acute cholecystitis
  • Conversion to open cholecystectomy or if the surgery exceeded 200 minutes
  • Severe systemic disease
  • Patients on analgesics for any reason
  • History of allergy to local anesthetics
  • An ongoing pregnancy
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Habib Thameur Hospital

Tunis, Tunisia

RECRUITING

Study Officials

  • BEN FADHEL Kamel, M.D

    Habib Thameur Hospital of Tunis, Department of Anesthesia

    STUDY DIRECTOR

Central Study Contacts

DAGHMOURI Mohamed Aziz, M.D

CONTACT

0029442474aziz.daghmouri@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 3, 2021

First Posted

October 26, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2021

Study Completion

January 31, 2022

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

TU(1)