NCT06393192

Brief Summary

included patients were divided into 4 groups and each group received a mode of post cesarian section analgesia and pain was assessed by visual analogue scale at rest and movement.

  1. 1.st group epidural analgesia
  2. 2.nd group Quadratus lumborum type 2
  3. 3.rd group Quadratus lumborum type 3
  4. 4.th group Quadratus lumborum type (2+3)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 27, 2024

Last Update Submit

April 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

    Total morphine consumption at specified intervals following operation in addition to postoperative pain assessment by the visual analogue scale (VAS, 0-100 mm) at rest and movement

    zero, four, six, twelve, twenty-four hours & forty-eight hours postoperatively

Secondary Outcomes (1)

  • The side effects of the different interventions

    four, six, twelve, twenty-four hours & forty-eight hours postoperatively

Study Arms (4)

Epidural analgesia (EA) only group

In this group 20 patients fulfilling the eligibility criteria, the epidural needle was inserted at the level of the intervertebral gap that separates the 2nd \& 3rd spinal bones. Upon locating the epidural space through the utilization of the loss of resistance to saline approach, the tip of a spinal needle was inserted through the epidural needle. In order to reach a specific level of sensory block up to the sixth thoracic dermatome, each pregnant woman was administered intrathecal anesthetic consisting of 0.75 percent bupivacaine in a volume of 1.3-1.7 milliliter. Subsequently, we removed the needle \& proceeded to place an epidural catheter through the epidural needle as a precautionary measure in the event of intrathecal anesthetic failure. The EA group received a single dosage of six milliliters of saline solution containing nine milligrams of bupivacaine (0.15%) \& 2 mg of morphine via the epidural catheter for postoperative pain management.

Procedure: Epidural analgesia (EA) only group

Quadratus Lumborum 2 (QL2) group

In this group 20 patients fulfilling the eligibility criteria, the ultrasound transducer was positioned horizontally at the level of L2-3 on both sides of the body. It was adjusted until the "Shamrock sign" created by the QL muscle, psoas major, and erector spinae was visible. The imaging depth was set among 0 as well as 9.9 cm. Needles were inserted from the front-lateral to back-medial direction. An injection of local anesthetic was administered behind the QL muscle.0.2% bupivacaine were administered at a volume of thirty milliliters at the specified sites on each side, resulting in a total of Sixty mL

Procedure: Quadratus lumborum block (QL2)

Quadratus Lumborum 3 (QL3) group

In this group 20 patients fulfilling the eligibility criteria, the ultrasound transducer was positioned horizontally at the level of L2-3 on both sides of the body. It was adjusted until the "Shamrock sign" created by the QL muscle, psoas major, and erector spinae was visible. The imaging depth was set among 0 as well as 9.9 cm. Needles were inserted from the front-lateral to back-medial direction. An injection of local anesthetic was administered among the QL and the psoas major muscles.0.2% bupivacaine were administered at a volume of thirty milliliters at the specified sites on each side, resulting in a total of Sixty mL

Procedure: Quadratus lumborum block 3(QL3)

Quadratus Lumborum 2+3 (QL2+3) group

In this group 20 patients fulfilling the eligibility criteria, the QL2+3 block can be performed in a single plane with only one puncture on each side. 0.2 percent bupivacaine solution of fifteen milliliters were administered at each injection site, with the needle being inserted once on each side

Procedure: Quadratus lumborum block 2+3 QL(2+3)

Interventions

The epidural needle will be inserted into the lumbar epidural space at the level of L2-3 intervertebral space.

Epidural analgesia (EA) only group

0.2% bupivacaine at a volume of thirty milliliters were administered at the specified sites on each side behind the QL muscle, resulting in a total of Sixty mL

Quadratus Lumborum 2 (QL2) group

0.2% bupivacaine at a volume of thirty milliliters were administered at the specified sites on each side among the QL muscle and the psoas major, resulting in a total of Sixty mL

Quadratus Lumborum 3 (QL3) group

0.2 percent bupivacaine solution of fifteen milliliters were administered at each injection site, with the needle being inserted once on each side

Quadratus Lumborum 2+3 (QL2+3) group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The current study is a prospective cohort study that was conducted on (80) patients in Sohag university hospital who were fulfilling the eligibility criteria and presented to the department of Obstetrics and Gynecology at Sohag University hospital (Egyptian tertiary referral hospital) who are requesting immediate postpartum analgesia. The attending physician had explained the nature of the study and all patients included signed an informed consent. All participants were subjected to thorough history taking including age, obstetric history, menstrual history, residency, occupation, medical history, surgical history and family history. Clinical examination and full investigations were done as preparation for elective cesarean section.

You may qualify if:

  • a normal singleton pregnancy lasting at least 37 weeks, body weight (50-70) kg, as well as having an American Society of Anesthesiologists (ASA) physical status I or II

You may not qualify if:

  • Individuals with a history of congenital coagulopathy, certain infections, or cognitive impairments that would prevent them from using the verbal rating pain score method or the patient-controlled analgesia (PCA) pump were not involved in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sohag University, Medical school

Sohag, 82524, Egypt

Location

Sohag University hospital

Sohag, Egypt

Location

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

April 27, 2024

First Posted

May 1, 2024

Study Start

October 1, 2023

Primary Completion

March 28, 2024

Study Completion

April 15, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Locations