Spinal Anaesthesia as an Adjunct to General Anaesthesia for Laparoscopic Abdominoperineal Rectal Amputation

Abstract

Background

Spinal anaesthesia as an adjunct to general anaesthesia may reduce postoperative pain and opioid consumption after laparoscopic abdominoperineal rectal amputation. We designed a randomized double blinded pilot study with two objectives: 1) to explore potential benefits of spinal anaesthesia as an adjunct to general anaesthesia and 2) to provide power and sample size estimations for potential differences between the groups. Primary outcome measures were postoperative pain and oral morphine equivalent (OMEq) consumption.

Methods

Patients scheduled for elective laparoscopic abdominoperineal rectal amputation at the University Hospital of North Norway were randomised to spinal (n=5) or a sham spinal procedure (n=5). Numeric rating scale (NRS) and OMEq were monitored postoperatively for 72 h.

Results

Age, sex, body mass index, and ASA were not significantly different between the groups. During surgery, patients in the spinal group received less remifentanil (p=0.06). NRS was lower in the spinal group 1 hr after admittance to the post-anaesthesia care unit (PACU) (p=0.06) and on the first postoperative day at 8 AM (p=0.03). OMEq consumption in the PACU was lower in the spinal group (p=0.008), but no differences between the groups were detected after discharge to the ward. Sample size estimations revealed that eight patients in each group would be needed to study potential NRS differences after admission to the PACU and 23 patients in each group to study potential differences in OMEq consumption on day 1.

Conclusion

Spinal anaesthesia as an adjunct to general anaesthesia reduces postoperative pain and opioid consumption after laparoscopic abdominoperineal rectal amputation. Data from the current study should be followed up by a sufficiently powered randomized controlled trial.

Clinical Trial Registration

Trial registered at https://clinicaltrials.gov (NCT05406765).

Keywords:

• anesthesiology
• opioid consumption
• rectal amputation
• spinal anesthesia
• surgery

Ethics Approval and Consent to Participate

The research protocol was approved by the regional committee for medical and health research ethics (REC 334882) and registered at https://clinicaltrials.gov (NCT05406765). The study was conducted at the University Hospital of North Norway, Tromsø with approval from the Institutional Regulatory Board (Record ID 2805). A written informed consent was obtained before inclusion.

Data Sharing Statement

The datasets generated during and/or analysed during the current study are available as individual deidentified participant data. All data will be shared on request for 3 years after the study has been published. Please contact the corresponding author if you would like to receive data from this study.

Institutional Review Board Contact Information

The regional committee for medical and health research ethics. Phone: [phone] (switch board) Email: [email protected] Uit- The Arctic University of Norway, 9038 Tromsø, Norway.

Key Messages Regarding Feasibility

• It was uncertain whether patients would benefit from a spinal anesthesia

• Spinal anesthesia as an adjunct to general anesthesia provides better pain control

• Data should be confirmed in a properly powered randomized clinical study

Acknowledgments

Statistician Lars Hindenes is acknowledged for his expert advice on statistical methods. Name of Departments and Institutions to which this work should be attributed:

Department of Anaesthesiology, University Hospital of North Norway and Acute and Critical Care Research Group, UiT – The Arctic University of Norway, Tromsø, Norway.

Author Contributions

All authors met the authorship criteria, read and approved the final version of this manuscript. All authors contributed to data analysis, drafting or revising the article, have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

The authors report no competing interests related to this work.

Additional information

Funding

This study has received departmental funding only.