To compare the pain relief from combined intrathecal bupivacaine-morphine with bupivacaine alone in lower limb surgery

Analgesic efficiency of intrathecal bupivacaine with morphine and bupivacaine alone in lower limb orthopaedic surgery. A comparative study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31685121

Enrollment

150

Registered

2022-05-12

Start date

2021-09-10

Completion date

Unknown

Last updated

2022-05-23

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

Conditions

Postoperative pain management in trauma patients Surgery

Interventions

After meeting the inclusion criteria, eligible patients received 15 mg preservative free hyperbaric bupivacaine and 0.2 mg morphine or 15 mg bupivacaine alone. Patients were followed up 72 hrs for pos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective lower limb orthopaedic surgery 2. ASA status class I and II 3. Patients between 16 - 60 years of age 4. Patients who were on admission for 72 hours or more postoperatively

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding mothers 2. Patients with polytrauma 3. Glasgow coma scale <15 4. Opioids abusers 5. Expected post-surgical stay <24 hours 6. ASA physical status class III and IV 7. Patients allergic to bupivacaine and/morphine 8. Contraindication to spinal anaesthesia

Design outcomes

Primary

Measure	Time frame
1. Vital signs (pulse rate, blood pressure, oxygen saturation, and respiratory rate) of the patient were monitored and recorded for every 5 minutes for the first 30 minutes and then for every 15 minutes during surgery 2. Pain severity was measured every 4 hours for 72 hours immediately after the surgery on a 100-mm VAS, 0 mm = no pain, and 100 mm = intolerable pain.	—

Secondary

Measure	Time frame
1. The episodes of postoperative nausea and vomiting (PONV) were identified by direct scheduled assessments or by a spontaneous complaint by the patients after the surgery. The incidence of PONV was recorded hourly for the first 4 hours and then 4 hourly for the next 24 hours using a 3 point ordinal scale (0 = none, 1 = nausea, 2 = vomiting). The incidence of PONV was calculated and categorized as early (0 – 4 hours) or delayed (5 – 24hours). 2. The incidence of pruritus was recorded every 4 hours for 48 hours after surgery on a four-point categorical scale as; 0 = no pruritus, 1 = mild, 2 = moderate, 3 = severe pruritus. 3. Overall perioperative satisfaction was evaluated on the day of discharged during an interview as; 4 = excellent, 3 = good, 2 = satisfactory, 1 = poor.	—

Measure

Time frame

1. The episodes of postoperative nausea and vomiting (PONV) were identified by direct scheduled assessments or by a spontaneous complaint by the patients after the surgery. The incidence of PONV was recorded hourly for the first 4 hours and then 4 hourly for the next 24 hours using a 3 point ordinal scale (0 = none, 1 = nausea, 2 = vomiting). The incidence of PONV was calculated and categorized as early (0 – 4 hours) or delayed (5 – 24hours). 2. The incidence of pruritus was recorded every 4 hours for 48 hours after surgery on a four-point categorical scale as; 0 = no pruritus, 1 = mild, 2 = moderate, 3 = severe pruritus. 3. Overall perioperative satisfaction was evaluated on the day of discharged during an interview as; 4 = excellent, 3 = good, 2 = satisfactory, 1 = poor.

—

Countries

Ghana

Outcome results

None listed

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