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COMPARISON of the EFFECT of TWO DIFFERENT ANALGESIS TECHNIQUES in ABDOMINAL HYSTERECTOMY

Comparison of the Analgesic Effect of Intrathecal Morphine and Bilateral Transversus Abdominis Plane Block in Patients Undergoing Elective Abdominal Hysterectomy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06815393
Enrollment
80
Registered
2025-02-07
Start date
2025-02-01
Completion date
2026-03-01
Last updated
2025-02-19

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

Conditions

Abdominal Hysterectomy

Keywords

abdominal hysterectomy, intratechal morphine, transversalis fascia plane block

Brief summary

Hysterectomy is one of the most commonly performed surgical procedures after cesarean section in many countries worldwide, especially among women of reproductive age. Postoperative pain is typically managed with oral and parenteral narcotics. Patient-controlled analgesia (PCA) is an effective pain management method that provides advantages such as faster pain relief, better dosage control, and elimination of the need for timer adjustments. Facilitating the recovery process and optimizing postoperative pain management are crucial components of perioperative care. To minimize systemic opioid requirements and opioid-related side effects, multimodal analgesia combining local anesthesia, peripheral, and non-opioid analgesics has become increasingly popular.

Interventions

OTHERIntratechal Morphine

Prior to induction, the patient will be positioned seated, and morphine will be slowly injected intrathecally at a dose of 5 μg/kg, adjusted to the L4-L5 or L3-L4 intervertebral space using a 27G pencil point spinal needle. The injection will be administered over approximately 10 seconds

Prior to induction, patients will be positioned supine, and bilateral transversus abdominis plane (TAP) block will be performed with the aid of ultrasound. As the blocking agent, 20 cc of 0.25% bupivacaine will be used bilaterally.

Sponsors

Ataturk Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Women aged between 18 and 65 years classified as ASA 1 and ASA 2.

Exclusion criteria

* Patients with allergies to the active substance, those with severe liver or renal insufficiency, a history of long-term nonsteroidal anti-inflammatory drug (NSAID) and opioid analgesic use, a history of gastrointestinal bleeding, peptic ulcer or inflammatory bowel disease, a history of diabetes or other neuropathic conditions, preoperative atrioventricular block and bradycardia, underlying serious respiratory diseases, a history of psychiatric disorders, patients classified as ASA stage 3 or higher, patients weighing less than 40 kg, patients unable to use the patient-controlled analgesia (PCA) device, and patients who need to discontinue the study medication during surgery for any reason will be excluded from the study

Design outcomes

Primary

MeasureTime frameDescription
Postoperatve Opioid Consumptionpostoperatively 24 hoursThe primary aim of this study is to compare the analgesic efficacy of intrathecal morphine and bilateral transversalis fascia plane block in patients undergoing elective abdominal hysterectomy, in terms of morphine consumption during the first 24 hours postoperatively

Secondary

MeasureTime frameDescription
Quality of recovery 24 hours after the surgery assessed using QoR-40 questionnairepostoperative 24 hourEvaluation of quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire
Advers Eventpostoperative 24 hourincidence of side effects (nause, vomiting, urinary retention) for 24 hours
Postoperative Pain Scores at movement and restpostoperatively 24 hoursevaluation of pain scores during movement and rest within 24 hours postoperatively using Visual Analogue Scale

Countries

Turkey (Türkiye)

Contacts

Primary ContactEmirhan Akarsu
emirhanakarsu@gmail.com+90 535 283 28 97

Outcome results

None listed

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