Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03394807
Other study ID # LaGRA-MRHM
Secondary ID
Status Completed
Phase Phase 4
First received December 15, 2017
Last updated January 8, 2018
Start date October 1, 2016
Est. completion date August 30, 2017

Study information

Verified date January 2018
Source Health Service Executive, Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.


Description:

A prospective, double blind, randomised controlled trial was performed. Consenting patients undergoing laparoscopic cholecystectomy were randomised, by envelope, to a laparoscopic guided 2-point blockade (subcostal transversus abdominis plane and rectus sheath) using either Chirocaine® 2.5mg/ml (LaGRA) or 0.9% Saline (Placebo) after specimen extraction.

Primary endpoints were post-operative pain in the first 6 hours. Secondary endpoints were analgesic/anti-emetic usage and day case and re-admission rates. Data was analysed using GraphPad Prism (V7).


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date August 30, 2017
Est. primary completion date July 30, 2017
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing laparoscopic cholecystectomy

- ASA I, II or III

Exclusion Criteria:

- Patients that don't consent to be included

- Allergy to levobupivacaine

Study Design


Intervention

Drug:
Levobupivacaine
Levobupivacaine injection to Transversus abdominis plane and rectus sheath
Placebo
Saline injection to Transversus abdominis plane and rectus sheath

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Health Service Executive, Ireland

Outcome

Type Measure Description Time frame Safety issue
Primary Post operative pain score Visual analogue pain scores ranging from 0 to 10 6 hours post operatively
Secondary Opioid use Amount (mg) of opioid medication administered Perioperative period including first 6 hours post operatively
Secondary Analgesic use Type and dose of all non opioid analgesic medications prescribed Perioperative period including first 6 hours post operatively
Secondary Readmission rate Patient readmitted to hospital for any reason 30 days post operative
Secondary Daycase rates Patient that was planned for daycase but admitted overnight Day of surgery
See also
  Status Clinical Trial Phase
Completed NCT01441141 - Genetics and Pain Severity in Sickle Cell Disease
Recruiting NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
Completed NCT01198197 - PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Early Phase 1
Enrolling by invitation NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03459872 - Acupuncture Outcomes Based Rehabilitation N/A
Recruiting NCT03256487 - Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department Phase 2
Recruiting NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Completed NCT02533908 - Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children Phase 3
Recruiting NCT02829736 - ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively N/A
Recruiting NCT02911168 - Comparison of US-Guided Paravertebral and Proximal Intercostal Nerve Blocks N/A
Recruiting NCT02943772 - Does Local Cooling of Testis in Patients With Epididymitis Relieve Pain and Reduce Quantity of Analgetics Intake? N/A
Active, not recruiting NCT02917603 - Shared Decision Making to Improve Palliative Care in the Nursing Home N/A
Not yet recruiting NCT02819544 - Evaluation of the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care Phase 3
Completed NCT02916927 - Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department Phase 4
Not yet recruiting NCT02834481 - Assessment of Pain Monitoring With ANI/NIPE Monitor Program in Pediatric Cardiac Surgery Postoperative. Phase 4
Not yet recruiting NCT02854553 - TAP Block Alone Versus TAPblock With Rectus Sheath Block in Liposuction Surgery N/A