NCT07280949

Brief Summary

The aim of this study is to compare perioperative analgesic efficacy and safety profile of combined SMPB and posterior TAP block versus posterior TAP block in patients undergoing laparoscopic colorectal cancer surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

December 1, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 1, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

transversus abdominis plane blockSacral blockLaparoscopicColorectal surgeries

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain score (VAS)

    (VAS) at rest and during coughing at 2hr postoperative.

    2 hours

Secondary Outcomes (8)

  • Fentanyl consumption

    6 hours

  • Time to first postoperative analgesic request

    24 hours

  • Total morphine requirements

    24 hours

  • Visual analogue pain score (VAS)

    24 hours

  • Quality of Recovery (QoR-15) scale

    24 hours

  • +3 more secondary outcomes

Study Arms (2)

SMPB & TAP Block Group (ST-Group): bilateral ultrasound-guided SMPB & TAP block

ACTIVE COMPARATOR

Patient in lateral position. A curvilinear ultrasound probe (5-7 MHz) will be placed longitudinally in midline just above median sacral crest. After identifying hyper echoic median sacral crest with overlying hypo echoic latissimus dorsi muscle, the probe will be moved laterally to identify intermediate crest, dorsal sacral foramina (DSF), longissimus thoracic muscle, and multifidus muscle (MFM). After optimizing the image at S2 level, 21G 80 mm block needle will be advanced in plane approach until needle reached sacral foramen. A distinct loss of resistance will be felt once the needle pierced the fibrous covering of S2 foramen. After negative aspiration, a total of 20 mL bupivacaine 0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side.

Procedure: sacral multifidus plane blockProcedure: TAP Block: posterior approach

TAP block Group (T-Group): this group will receive bilateral ultrasound-guided TAP block

EXPERIMENTAL

Technique of TAP Block: posterior approach The patient in semi-lateral position. A linear ultrasound probe (4-12MHz) will be placed posterior to the mid-axillary line between the costal margin and the iliac crest. When scanning posteriorly, transversus abdominis tailed off and turned into aponeurosis. Subsequently, a blunt-ended needle will be introduced into the TAP between the internal oblique and transversus abdominis, posterior to the mid-axillary line and near the aponeurosis. After confirmation with saline solution into the facial plane, as the appearance of a hypo echoic ellipsoid with well-defined margins on ultrasound imaging. After negative aspiration, a total of 20 mL bupivacaine0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side.

Procedure: TAP Block: posterior approach

Interventions

The patient in lateral position. A curvilinear ultrasound probe (5-7 MHz) will be placed longitudinally in the midline just above the median sacral crest. After identifying the hyper echoic median sacral crest with the overlying hypo echoic latissimus dorsi muscle, the probe will be moved laterally to identify the intermediate crest, the dorsal sacral foramina (DSF), longissimus thoracic muscle, and multifidus muscle (MFM). After optimizing the image at the S2 level, a 21G 80 mm block needle will be advanced in an in plane approach until the needle reached the sacral foramen. A distinct loss of resistance will be felt once the needle pierced the fibrous covering of S2 foramen. After negative aspiration, a total of 20 mL bupivacaine 0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side

SMPB & TAP Block Group (ST-Group): bilateral ultrasound-guided SMPB & TAP block

The patient in semi-lateral position. A linear ultrasound probe (4-12MHz) will be placed posterior to the mid-axillary line between the costal margin and the iliac crest. When scanning posteriorly, transversus abdominis tailed off and turned into aponeurosis. Subsequently, a blunt-ended needle will be introduced into the TAP between the internal oblique and transversus abdominis, posterior to the mid-axillary line and near the aponeurosis. After confirmation with saline solution into the facial plane, as the appearance of a hypo echoic ellipsoid with well-defined margins on ultrasound imaging. After negative aspiration, a total of 20 mL bupivacaine0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side.

SMPB & TAP Block Group (ST-Group): bilateral ultrasound-guided SMPB & TAP blockTAP block Group (T-Group): this group will receive bilateral ultrasound-guided TAP block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 90 years
  • Male or female
  • ASA class I to III
  • Elective laparoscopic or robotic colorectal surgery with or without resections requiring perineal incisions.

You may not qualify if:

  • Patient refusal
  • History of previous abdominal surgery, preoperative bowel obstruction symptoms, and requirement for emergency surgery
  • Conversion to open laparotomy
  • Coagulopathy, infection at the injection site, allergy to local anesthetics, body mass index \> 30 kg/m2, severe hepatic or renal disease, severe cardiopulmonary disease (≥ ASA IV), diabetic or other neuropathies, patients receiving opioids for chronic analgesic therapy, inability to comprehend visual analogue scale (VAS) and patients transferred to the intensive care unit (ICU) post-surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Governorate, 002, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 15, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations