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Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Comparison Between Ultrasound Guided Erector Spinae Plane Block and Intrathecal Morphine

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05218733
Enrollment
120
Registered
2022-02-01
Start date
2022-02-15
Completion date
2023-09-20
Last updated
2023-10-03

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

Conditions

Post Operative Pain

Brief summary

Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. Intrathecal opioid administration is an attractive analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close to the structures of the central nervous system where the opioid acts.

Interventions

General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive bilateral ultrasound-guided ESPB by the an experienced anesthetist in US regional blocks, with each block 20 mL of bupivacaine 0.25%

DRUGIntra thecal morphine.

General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive intra thecal morphine with spinal needle 25G, 3 ml containing 300 ug preservative free morphine

DRUGGeneral anesthesia using intravenous fentanyl (1µgm/kg)

Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Body mass index (BMI) 25 to 35kg/m². * American Society of Anesthesiologist (ASA) physical status I or II.

Exclusion criteria

* patient's refusal * Altered mental status * Known allergy to study drugs (bupivacaine or morphine) * Local infection at site of puncture. * Known case with any pulmonary disease * Known case with Obstructive sleep apnea (OSA) * Coagulopathy and /or thrombocytopenia * Chronic pain * Severe hepatic or kidney impairment

Design outcomes

Primary

MeasureTime frameDescription
The time for requirement of first rescue analgesic (min)24 hours postoperativelyThe time for requirement of first rescue analgesic (min)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026