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Comparative Study on the Effect of Quadratus Lumborum Block Versus Intrathecal Morphine on the Incidence of Chronic Pain Post Caesarean Section in a University Hospital of Middle-income Country

Comparative Study on the Effect of Quadratus Lumborum Block Versus Intrathecal Morphine on the Incidence of Chronic Pain Post Caesarean Section in a University Hospital of Middle-income Country; A Randomized Control Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05602038
Enrollment
100
Registered
2022-11-01
Start date
2023-02-01
Completion date
2023-12-12
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Post Cesarean Pain

Brief summary

The aim of this study is to compare the incidence of CPSCP in patients receiving QLB quadratus lumborum block and ITM versus control as a primary outcome and associated risk factors that might predispose patients to develop CPSCP.

Detailed description

The aim of this study is to compare the incidence of chronic post cesarean pain in patients receiving quadratus laborum block and and intrathecal morphine versus control as a primary Study design: Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Data will be collected regarding the demographic data, gestational stage, parity and number of previous cesarean section, previous abdominal surgeries, and narcotic consumption. Postoperative pain day 1 and day2 will be followed by anesthetist who is blinded to the applied technique used. Follow up for the subsequent period of observation (2,4and 6 months) will be done by the department secretary who will contact the patients by phone to ask them if there is any concern after the operation. If the patient refers to a pain at the surgical site that has been lasting for the past three months a call will be conducted by the anesthetist and a referral schedule will be appointed to the pain clinic consultant for further evaluation

Interventions

PROCEDUREQuadratus laborum block

quadratus lumborum block will be performed using ultrasound machine (Sonosite Portable Ultrasound System, SonoSite, Bothell, Washington, USA). A 5-8 MHZ curved probe will be used with the patient positioned on the lateral side

DRUGIntrathecal morphine

Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg

intrathecal bupivacaine 0.5% 15mg and fentanyl

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block

Intervention model description

randomized control study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* patients admitted to the operating theatre for elective caesarean section

Exclusion criteria

* lack of informed consent * Allergy to drugs used during the study * Depression and epilepsy that required antidepressants or anticonvulsants * known coagulopathy as a contraindication for spinal anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scaleSix monthsAs zero is no pain and 10 is the maximum pain that can be felt

Secondary

MeasureTime frameDescription
narcotic consumption48 hoursnarcotic consumption

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026