Skip to content

Analgesic and anaesthetic effects of spinal opioid added to local anaesthetic for perioperative management of minor anorectal surgery

Spinal anaesthesia with 4 mg versus 3 mg of hyperbaric bupivacaine plus 10 µg of fentanyl for adult anorectal surgery: faster recovery with prolonged analgesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84658134
Enrollment
124
Registered
2024-10-04
Start date
2005-12-15
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Sensory, motor and analgesic effects of spinal anesthesia Surgery

Interventions

Patients are allocated randomly to one of two groups using sealed envelopes: Group S3F (n = 65) receive 3 mg (0.6 ml) of spinal 0.5 % hyperbaric bupivacaine along with 10 µg (0.2 ml) to a total volume

Sponsors

Lithuanian University of Health Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult consecutive patients admitted for elective minor anorectal surgery

Exclusion criteria

Exclusion criteria: 1. ASA physical scale greater than 3 2. Body mass index (BMI) exceeding 30 kg/m² 3. Unfit for spinal anaesthesia 4. Under chronic use of psychotropic or analgesic medications 5. Unwilling to participate

Design outcomes

Primary

MeasureTime frame
Duration of sensory block is regarded as the primary variable. Level and duration of sensory block is measured using dermatomes and alcohol swab at 10 min after dural puncture and, at the end of surgery, in postoperative ward every 30 minutes until full resolution of the block.

Secondary

MeasureTime frame
1. Demographics using patient records (age, gender, type of surgery) at patient arrival. 2. Duration of anaesthesia measured using time record at time from dural puncture until patient left the operating room. 3. Duration of surgery measured using time record from the start to the end of surgery. 4. Rate of success and failed block determined as the ability to make a dural puncture at the start of anaesthesia. 5. Level and duration of motor block measured using Bromage scale at 10 minutes after dural puncture, at the end of surgery, in postoperative ward every 30 minutes until full resolution of the block. 6. Time to voiding measured using time record at the moment of first postoperative urination. 7. Time to ambulation measured using time record at the time of the patient's ability to walk without assistance. 8. The rate of postoperative complications measured using patient complaints and recovery records: pruritus measured as patient complaint after resolution of the spinal block; urinary retention measured using patient complaints and recovery records on 0-2 point scale (where 0 = normal urination, 1 = difficult spontaneous urination, 2 = unable to urinate and catheterisation is required) at patient discharge. 9. Level of pain using VAS scale 0-100 at 1.5, 2, 2.5, 3, 6, 9, 12, 18 and 24 h postoperatively at rest and movement. 10. Consumption of analgesics measured counting the total doses of opioid and non-opioid analgesics consumed over 24 h postoperatively. 11. Quality of anaesthesia according to the patient and medical staff is measured using a scale of 0 – 2 scores at patient discharge from the operating room (surgeon and anaesthesiologist) and at patient discharge from the hospital (surgical ward nurse, patient). 12. Data collection is continued until patient discharge or until 24 h postoperatively and is stopped at 24 h after surgery.

Countries

Lithuania

Contacts

Public ContactJurate;Tautvydas Gudaityte;Scefanavicius

;

jurate.gudaityte@kaunoklinikos.lt;tautvydas.scefanavicius@stud.lsmu.lt+370 69808531;+370 37326221

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026