NCT06359743

Brief Summary

Pain following laparoscopic hysterectomy may interfere with early ambulation, discharge of patient from hospital and interfere with enhanced recovery with more opioid consumption. Most of methods for postoperative pain depend on the use of high doses of opioids with more side effects such as nausea, vomiting, respiratory center depression, delay bowel motility and hemodynamics instability. To decrease of opioid consumption in postoperative pain management as well as related side effects, previous studies showed that quadratus lumborum block or superior hypogastric plexus block (SHPB) had shown promising success in management of postoperative pain in patients undergoing laparoscopic hysterectomy. The present study will be conducted to compare of ultrasound guided QL block and laparoscopic superior hypogastric plexus block as a part of multimodal analgesia may allow adequate analgesia and decrease the overall use of opioids and allow patient enhanced recovery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

April 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 7, 2024

Last Update Submit

April 7, 2024

Conditions

Post Hysterectomy Pain

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption decrease

    Avoid excessive usage of opioid by regional blocks

    24hours

Study Arms (2)

Group QL:

EXPERIMENTAL

patients will receive Ultrasound Guided bilateral QL lumborum block (Anterior Approch) by anesthesiologist (20 ml of 0.25% bupivacaine hydrochloride at each side).

Procedure: Quadratus Lamborum versus superior hypogatric

Group SH:

EXPERIMENTAL

will receive laparoscopic Superior Hypogastric block by gynecologist (30 ml of 0.25% bupivacaine hydrochloride ).

Procedure: Quadratus Lamborum versus superior hypogatric

Interventions

Quadratus Lamborum versus superior hypogatricPROCEDURE

Ultrasound Guided Quadratus Lumborum Block versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia after Laparoscopic Hysterectomy

Group QL:Group SH:

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent from the patient.
  • BMI of less than or equal 30.0 kg m-2.
  • Age 45-60 years old.

You may not qualify if:

  • \. Allergy to local anesthetics. 2. Infection at site of injection. 3. Patients with coagulopathy. 4. Patients with chronic pain syndromes. 5. Physical and mental disease which could interfere with pain scores evaluation.
  • \. Patients with distorted local anatomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Zagazig university

Zagazig, Sharqia Province, Egypt

Location

Related Publications (2)

  • Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.

    PMID: 28043841BACKGROUND

  • Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

    PMID: 23392233BACKGROUND

Study Officials

  • Eslam S Almaghawry Mohamed, MD

    Faculty of medicine, Zagazig university

    STUDY CHAIR

  • Abdalla H Gad, MD

    Faculty of medicine, zagazig university

    STUDY CHAIR

  • Mohamed A Wasfy, MD

    Faculty of medicine, zagazig university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Abdalla mohamed goda mohamed ,MD

Study Record Dates

First Submitted

April 7, 2024

First Posted

April 11, 2024

Study Start

April 1, 2024

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Locations

EG(1)